NanOlogy Announces Initiation of a Lung Cancer Clinical Trial Following FDA Allowances of Two IND Applications for NanoPac® in Lung Cancer

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NanOlogy Announces Initiation of a Lung Cancer Clinical Trial Following FDA Allowances of Two IND Applications for NanoPac® in Lung Cancer

  • First-in-human clinical trial of intratumoral (IT) injections of NanoPac in non-small cell lung cancer (NSCLC) and small cell lung cancer (SCLC) is expected to begin enrollment in August
  • The clinical trial follows FDA allowance of IT NanoPac in neoplasms of the lung
  • FDA also allowed a second IND for nebulized inhalation of NanoPac in NSCLC

FT. WORTH, (June 9, 2020) — NanOlogy, LLC, a clinical-stage oncology company, announced today initiation of a clinical trial of IT NanoPac® (submicron particle paclitaxel) for suspension via endobronchial ultrasound-guided transbronchial needle injection (EBUS-TBNI) in NSCLC and SCLC. The trial follows FDA allowance of an investigational new drug (IND) application for IT NanoPac in neoplasms of the lung. A second IND was also allowed by FDA for a nebulized inhaled form of NanoPac in NSCLC. Five INDs have been established for NanoPac allowing progress of clinical trials via multiple routes of targeted administration for a variety of solid tumors including pancreatic, prostate, ovarian, peritoneal, and now lung.

Clinical Trial of NanoPac in Lung Cancer
The first study to proceed will be a Phase 2a dose-rising and expansion trial (NCT04314895) evaluating the safety and tolerability of up to 3 monthly IT injections of NanoPac delivered via EBUS-TBNI, concurrent with standard of care therapy, in patients with primary or recurrent NSCLC or SCLC. In addition to safety and pharmacokinetics (PK), the study will measure progression free survival, overall survival, and tumor response determined from CT scan imaging. Blood and biopsy samples will be evaluated for immune effect through flow cytometry and multiplex immunohistochemistry analysis. The trial will begin at two clinical sites: Parkview Healthcare Institute in Fort Wayne, Indiana and University of Florida Health Cancer Center in Gainesville, Florida. More clinical sites will follow. The first subject is expected to be enrolled in August 2020.

Preclinically, a nebulized inhaled form of NanoPac was retained in lung tissue for more than 14 days in a PK model and caused tumor regression and immune cell infiltration in an orthotopic model of NSCLC. Clinical plans for inhaled NanoPac are under development.

Other Clinical Experience with Targeted Delivery of NanoPac
To date, approximately 70 patients have received targeted injections of NanoPac across clinical trials in the prostate and pancreas. Another 30 patients have received intraperitoneal NanoPac for peritoneal and ovarian cancers. NanoPac has been well tolerated in these study subjects with no confirmed drug-related serious adverse events reported. Along with safety and tolerability, signs of activity have also been observed across the clinical programs.

NanOlogy Submicron Particle Therapeutic Platform
The NanOlogy submicron particle therapeutic platform is based on a proprietary production technology that converts taxane API crystals into stable submicron particles of pure drug with disproportionate size to surface area ratio. The particles are covered by two composition of matter patents (US 9,814,685) and (US 10,507,195) both valid until 2036 in the US and pending globally. In addition to lung cancer, NanOlogy clinical programs are advancing in pancreatic, genitourinary, peritoneal, ovarian, and dermal cancers. 

About Lung Cancer
In 2020, an estimated 228,820 new cases of lung cancer will be diagnosed in the U.S. and 135,720 people will die from the disease. Lung cancer is by far the leading cause of cancer deaths in the U.S. responsible last year for 22% of all cancer-related deaths (SEER). Globally, lung cancer is also the most common form of cancer and the deadliest accounting for an estimated 2.1 million annual new cases and 1.8 million deaths (GLOBOCAN 2018).

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About NanOlogy
NanOlogy, LLC (www.nanology.us) is a private clinical-stage oncology company formed in 2015 to finance and clinically develop a patented submicron particle technology platform for targeted, sustained delivery of proven drugs aimed at increasing their value in the treatment of cancer and other serious diseases.

Disclaimers
This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements about our product development, business, and other activities. Such statements are subject to the risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical trial, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement and the company disclaims any intent or obligation to update these statements. NanOlogy investigational drugs have not been proven to be safe and effective as required by U.S. FDA and have not been approved for commercial distribution. NanOlogy and NanoPac are trademarks of NanOlogy LLC.

Media Contact

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
404-245-0591

NanOlogy Presents Updated Clinical Data on Targeted Injections of NanoPac® for Pancreatic Cancer and Mucinous Cystic Neoplasms on DDW2020 Site

NanOlogy Presents Updated Clinical Data on Targeted Injections of NanoPac® for Pancreatic Cancer and Mucinous Cystic Neoplasms on DDW2020 Site

 

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NanOlogy Presents Updated Clinical Data on Targeted Injections of NanoPac® for Pancreatic Cancer and Mucinous Cystic Neoplasms on DDW2020 Site

Updated clinical data from both trials available through Digestive Disease Week® (DDW) Online Education Site

FT. WORTH, (May 14, 2020) — NanOlogy, LLC, a clinical-stage oncology company, announced today that updated data from two of its ongoing clinical trials were presented as abstracts last week through the DDW ePosters and ePresentations site . The clinical trials are evaluating endoscopic ultrasound guided fine needle injection (EUS-FNI) of NanoPac® (submicron particle paclitaxel) suspension for treatment of locally advanced pancreatic cancer (LAPC) and mucinous cystic neoplasms (MCNs/IPMNs) of the pancreas.

The lead author of the abstract on intratumoral NanoPac for LAPC is Neil Sharma, MD (Parkview Cancer Institute – Fort Wayne, IN). The lead author of the abstract on intracystic NanoPac for MCNs/IPMNs is Mohamed O. Othman, MD (Baylor College of Medicine – Houston, TX).

Pancreatic Cancer

The Phase 2a dose-rising and expansion trial is evaluating over 6 months the safety and preliminary efficacy of NanoPac delivered intratumorally by EUS-FNI in patients with LAPC, concurrent with or following SOC therapy for the disease. After completing the dose-rising cohort (n=11), a dose expansion cohort has now fully enrolled (n=22) in which patients receive 2 monthly intratumoral (IT) injections of NanoPac. FDA has also recently allowed expansion of up to 30 additional patients who will receive up to 4 monthly IT injections.

Dr. Sharma’s abstract submitted to DDW in December 2019 reports data from the first 7 evaluable subjects from the dose expansion cohort. No drug-related local or systemic SAEs were reported including no reports of acute pancreatitis in any subject, 4 subjects had a partial response, 2 had stable disease, and 1 had progressive disease. Encouraging data has continued to accrue from the fully enrolled dose expansion (2- injection) cohort, which are expected to be presented later in 2020

Pancreatic Cyst

The Phase 2a dose rising and expansion trial is evaluating over 6 months the safety and preliminary efficacy of NanoPac delivered intracystically by EUS-FNI following aspiration in patients with MCNs/IPMNs. The study has now completed enrollment (n=19) with patients in the dose expansion phase (n=8) receiving two intracystic injections of NanoPac 12 weeks apart.

Dr. Othman’s abstract also submitted in December reports data from the first 9 subjects who had completed the trial. No confirmed drug-related local or systemic SAEs were reported including no reports of acute pancreatitis. Plasma paclitaxel levels have not exceeded 1 ng/mL indicating that NanoPac particles are retained in the cyst over time. Evaluation of cyst volume showed decreases ranging from 8% to 89% in 8 subjects, 6 of whom showed a volume decrease > 50%. Cyst volume increased in 1 subject.

Based on encouraging results from both trials, NanOlogy is designing follow-on clinical protocols for evaluation by FDA.

In 2020, about 57,600 new cases of pancreatic cancer will be diagnosed in the U.S. and 47,050 people will die from the disease. Pancreatic cancer is currently the third most frequent cause of cancer related death in western countries and is predicted to become the second leading cause of death from cancer within the next 10 years. It is one of the few cancers for which no meaningful improvement in survival has been achieved over recent time with only an 8% survival rate at 5 years.

MCNs/IPMNs are a subset of pancreatic cysts that risk progression to pancreatic cancer. While estimates vary widely, as many as 30,000 new cases of high risk MCNs/IMPNs are diagnosed annually in the U.S. These patients may ultimately be required to undergo surgical resection of the pancreas to remove the lesion, a complicated procedure associated with high morbidity. No approved drug therapy exists in the U.S to treat the condition.

In addition to pancreatic neoplasms, NanOlogy clinical programs are advancing in genitourinary, peritoneal, lung, and dermal cancers.

The NanOlogy submicron particle therapeutic platform is based on a proprietary production technology that converts taxane API crystals into stable submicron particles of pure drug with disproportionate size to surface area ratio. The particles are covered by two composition of matter patents (US 9,814,685) and (10,507,195) both valid until 2036 in the US and pending globally.

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About NanOlogy

NanOlogy, LLC (www.nanology.us) is a private clinical stage oncology company formed in 2015 to finance and clinically develop a patented submicron particle technology platform for targeted, sustained delivery of proven drugs aimed at increasing their value in the treatment of cancer and other serious diseases.

 

Disclaimers

This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements about our product development, business, and other activities. Such statements are subject to the risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical trial, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement and the company disclaims any intent or obligation to update these statements. NanOlogy investigational drugs have not been proven to be safe and effective as required by U.S. FDA and have not been approved for commercial distribution. NanOlogy and NanoPac are trademarks of NanOlogy LLC.

Media Contact

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
404-245-0591

NanOlogy Clinical Updates on Local Injection of NanoPac® for Pancreatic Cancer and Mucinous Cystic Neoplasms of the Pancreas

NanOlogy Clinical Updates on Local Injection of NanoPac® for Pancreatic Cancer and Mucinous Cystic Neoplasms of the Pancreas

 

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NanOlogy Clinical Updates on Local Injection of NanoPac® for Pancreatic Cancer and Mucinous Cystic Neoplasm of the Pancreas

Interim data from both clinical trials presented at the 2019 American College of Gastroenterology (ACG) Conference in San Antonio

FT. WORTH (November 7, 2019) — NanOlogy LLC, a clinical-stage oncology company, announced today that interim data were presented last week at the 2019 ACG annual meeting from two of its clinical trials each evaluating endoscopic ultrasound guided fine needle injection (EUS-FNI) of NanoPac (submicron particle paclitaxel): one for treatment of locally advanced pancreatic cancer (LAPC) and the other for treatment of mucinous cystic neoplasms of the pancreas (MCNs).

The pancreatic cancer clinical update of intratumoral NanoPac for treatment of LAPC was presented by Simon K. Lo, MD (Cedars-Sinai) as part of the Pancreatic Cancer/Esophagus plenary session.

The Phase 2a dose-rising and expansion pancreatic cancer trial is evaluating the safety and preliminary efficacy of NanoPac delivered intratumorally by EUS-FNI over 6 months in patients with nonresectable LAPC. After completion of the dose-rising phase, the trial has now enrolled 16 of 22 subjects into the dose expansion phase of the trial in which patients are receiving two intratumoral injections of NanoPac 4 weeks apart.

Highlights from Dr. Lo’s presentation on the dose expansion phase of the trial:

  • No drug-related local or systemic serious adverse events have been reported to date (n=25) including no reports of acute pancreatitis.
  • Of 7 subjects who have completed the 6-month study to date, one subject had a partial response with restaging from nonresectable to resectable (see video), 3 had stable disease, 1 had progressive disease, and 2 were withdrawn from the study.
  • Tumor volume decreases ranging from 7% to 76% have been seen in 7 of 11 subjects upon latest mpMRI to date at either the 3- or 6-month time point.
  • CA19-9 reductions of greater than 20% have been seen in 5 of 11 subjects upon latest measure to date at either the 3- or 6-month time point.

The pancreatic cyst clinical update on intracystic NanoPac for treatment of MCNs of the pancreas was presented during the poster sessions by Mohamed O. Othman, MD (Baylor College of Medicine). Dr Othman’s poster was recognized as a Presidential Poster, a distinction given to fewer than 5% of accepted abstracts each year, and was ultimately named co-winner for high quality, novel, unique and interesting research.

The Phase 2a dose rising and expansion pancreatic cyst trial is evaluating the safety and preliminary efficacy of NanoPac delivered intracystically by EUS-FNI following aspiration in patients with MCNs. The study is also enrolling in the dose expansion phase of the study and patients are receiving two intracystic injections of NanoPac 12 weeks apart.

Highlights from Dr. Othman’s poster presentation on the trial:

  • No drug-related local or systemic serious adverse events (SAE) have been reported to date (n=15) including no reports of acute pancreatitis. One case of gastric outlet obstruction that was possibly drug-related occurred in a subject who had a recent unrelated endoscopic procedure for hepatobiliary dysfunction. This condition was subsequently added as an exclusion criterion for the trial.
  • Plasma paclitaxel levels for all subjects analyzed have not exceed 1ng/mL suggesting that NanoPac particles are retained in the cyst over time.
  • Cyst volume decreases ranging from 8% to 89% have been seen in 9 of 11 subjects at last available imaging at either the 3- or 6-month time point.

Nanology plans to design follow-on clinical trials for both pancreatic cancer and pancreatic cysts in 2020 to further advance the programs toward regulatory submission.

In 2019, an estimated 57,000 new cases of pancreatic cancer will be diagnosed in the U.S. and 46,000 people will die from the disease. Pancreatic cancer is among the deadliest cancers with 9% survival rate at 5 years. It is also one of the few cancers for which no meaningful improvement in survival has been achieved in the last two decades. MCNs are a subset of pancreatic cysts that risk progression to pancreatic cancer. Patients with high risk MCNs may undergo surgical resection of the pancreas to remove the lesion, a complicated procedure associated with mortality and morbidity rates of 2% and 30% respectively. For both the disease itself and one of its common precursors, Nanology investigational drugs may offer a new way to help prevent or treat pancreatic cancer.

In addition to these trials, NanOlogy is advancing its therapeutic platform in preclinical and clinical programs across genitourinary, peritoneal, lung, and dermal cancers. The NanOlogy therapeutic platform is based on a proprietary submicron particle production technology that reduces the size of taxane API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The characteristics of the particles have recently been granted a composition of matter patent valid in the US (9,814,685) and Australia until 2036, and pending globally.

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About NanOlogy
NanOlogy, LLC (www.nanology.us) is a private clinical-stage oncology company developing a submicron particle therapeutic platform designed for local delivery to increase the effectiveness of cancer treatment while reducing the serious adverse effects normally associated with systemic chemotherapy.

Disclaimers
This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements about our product development, business, and other activities. Such statements are subject to the risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical trial, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement and the company disclaims any intent or obligation to update these statements. NanOlogy investigational drugs have not been proven safe and effective as required by U.S. FDA and have not been approved for commercial distribution.

Media Contact

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
404-245-0591

NanOlogy to Present Interim Data for Pancreatic Cancer and Mucinous Cystic Neoplasms of the Pancreas with Local Injection of NanoPac®

NanOlogy to Present Interim Data for Pancreatic Cancer and Mucinous Cystic Neoplasms of the Pancreas with Local Injection of NanoPac®

 

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NanOlogy to Present Interim Data for Pancreatic Cancer and Mucinous Cystic Neoplasms of the Pancreas with Local Injection of NanoPac®

Abstracts will be presented at the 2019 American College of Gastroenterology (ACG) Conference in San Antonio

FT. WORTH, (October 15, 2019) — NanOlogy LLC, a clinical-stage oncology company, announced today that abstracts for two of its clinical studies each evaluating endoscopic ultrasound guided fine needle injection (EUS-FNI) of NanoPac (submicron particle paclitaxel), one for treatment of locally advanced pancreatic cancer and the other for treatment of mucinous cystic neoplasms of the pancreas, were accepted for presentation at the 2019 American College of Gastroenterology Conference in San Antonio, Texas.

The pancreatic cancer abstract presents interim clinical data on intratumoral delivery of NanoPac for treatment of locally advanced pancreatic cancer on October 29th at 8:40AM by Simon K. Lo, MD (Cedars-Sinai) as part of plenary session 2B (Pancreatic Cancer/Esophagus) in the Stars at Night Ballroom-B4 of the Henry B. Gonzalez Convention Center.

The pancreatic cyst abstract is a mid-study report of safety and preliminary efficacy on intracystic delivery of NanoPac presented by Mohamed O. Othman, MD (Baylor College of Medicine) on October 28th from 10:30AM to 4:15PM as part of the Biliary/Pancreas poster session in Exhibit Hall 3/4 (P0930) of the convention center. Dr Othman’s poster received the Presidential Poster Award.

The Phase 2a dose-rising and expansion pancreatic cancer trial is evaluating the safety and preliminary efficacy of NanoPac delivered intratumorally by EUS-FNI in patients with locally advanced pancreatic cancer. The study is currently enrolling in the dose expansion phase of the study and patients are receiving two intratumoral injections of NanoPac four weeks apart.

In 2019, an estimated 57,000 new cases of pancreatic cancer will be diagnosed in the U.S. and 46,000 people will die from the disease. Despite being relatively rare, pancreatic cancer is the third leading cause of cancer death in the USA with a survival rate of only 25% at one year and less than 10% at five years. Pancreatic cancer is so deadly because it is seldom diagnosed at an early stage and tends to be aggressive and resistant to systemic chemotherapy. Recent advances in abdominal imaging hold the promise for earlier diagnosis of pancreatic cancer and the ability to treat the disease before it spreads to other parts of the body. If successful, NanOlogy may provide a local therapy to assist in the treatment of patients with pancreatic cancer.

The Phase 2a dose-rising and expansion pancreatic cyst trial is evaluating the safety and preliminary efficacy of NanoPac delivered intracystically by EUS-FNI following aspiration in patients with mucinous cystic neoplasms (MCNs). The study is also enrolling in the dose expansion phase of the study and patients are receiving two intracystic injections of NanoPac twelve weeks apart.

Pancreatic cysts are diagnosed in more than a 500,000 people annually in the United States and their diagnoses are increasing with advances in imaging technology. MCNs are a subset of pancreatic cysts that risk progression to pancreatic cancer. Patients with high risk MCNs may undergo surgical resection of the pancreas to remove the lesion, a complicated procedure associated with mortality and morbidity rates of 2% and 30% respectively. If successful, intracystic injection of NanoPac may provide an alternative to surgery for these patients.

In addition to these trials, NanOlogy is advancing its therapeutic platform in preclinical and clinical programs across genitourinary, gastrointestinal, peritoneal, lung, and dermal cancers.

The NanOlogy therapeutic platform is based on a proprietary submicron particle production technology that reduces the size of taxane API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The characteristics of the particles have recently been granted a composition of matter patent valid in the US (9,814,685) and Australia until 2036, and pending globally.

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About NanOlogy

NanOlogy, LLC (www.nanology.us) is a private clinical-stage oncology company formed in 2015 to finance and clinically develop a patented submicron particle technology platform for local, sustained delivery of therapeutic agents aimed at increasing their value in the treatment of cancer and related conditions.

Disclaimers

This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements about our product development, business, and other activities. Such statements are subject to the risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical trial, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement and the company disclaims any intent or obligation to update these statements. NanOlogy investigational drugs have not been proven safe and effective as required by U.S. FDA and have not been approved for commercial distribution.

Media Contact

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
404-245-0591

NanOlogy to Present Preclinical Lung Cancer Study Showing Inhaled NanoPac® Resulted in Increased Tumor Regression and Immune Response

NanOlogy to Present Preclinical Lung Cancer Study Showing Inhaled NanoPac® Resulted in Increased Tumor Regression and Immune Response

 

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NanOlogy to Present Preclinical Lung Cancer Study Showing Inhaled NanoPac® Resulted in Increased Tumor Regression and Immune Response

Abstract will be presented at the 2019 American Thoracic Society (ATS) International Conference in Dallas

FT. WORTH, (May 14, 2019) — NanOlogy LLC, a clinical-stage oncology company, announced today that its abstract showing encouraging therapeutic effects from a preclinical pharmacology study on inhaled NanoPac® (submicron particle paclitaxel) for treatment of lung cancer has been accepted for presentation at the 2019 American Thoracic Society International Conference.

The abstract, entitled Enhanced Tumor Regression and Immune Cell Infiltration by Inhaled Submicron Particle Paclitaxel in an Orthotopic Athymic Nude Rat Model of Non-Small Cell Lung Cancer (NSCLC), will be presented at the conference on May 20th, 1 PM to 4 PM, during the Oncogenic Mutations, Metastases, and Novel Therapeutics poster session at the Kay Bailey Hutchison Convention Center in Dallas.

Previously, NanOlogy conducted a pharmacokinetic study examining retention of NanoPac in healthy rat lung tissue following a single inhalation via nose-only exposure chamber. Data showed measurable amounts of drug in lung tissue 14-days post exposure, with treated lungs microscopically indistinguishable from normal lung tissue. A preclinical proof-of-concept study was then conducted to examine the therapeutic effect of inhaled NanoPac in an orthotopic athymic nude rat model of NSCLC. An abstract of that study was presented at the 2018 ASCO Annual Meeting showing inhaled NanoPac achieved a significant decrease in primitive tumor cell population as well as significant tumor reduction.

The ATS abstract presents follow-on immunohistochemical analysis of lung tissue from the proof-of concept study, which showed NanoPac-treated animals had greater incidence and degree of tumor regression, immune cell infiltration, and tertiary lymphoid structures compared to untreated controls and intravenously administered nab-paclitaxel.

Describing the antitumoral immune response, Gere diZerega, MD, VP of Medical Affairs, observed, “Immunohistochemical analysis showed the immune cell infiltrates appeared to facilitate destruction of tumor and its conversion into small fibrin deposits.”

NanOlogy is finalizing preclinical work of inhaled NanoPac in preparation for an investigational new drug (IND) submission to the US FDA in mid-2019 to allow for clinical trials in NSCLC.

During the conference, NanOlogy has also been selected to participate in the International Society for Aerosols in Medicine/ATS Pre-Conference session on “Current Practice and Future Developments in Aerosol Medicine.” The session will be held on Saturday, May 18, from 1 PM to 4 PM at the Omni Dallas Hotel Trinity Ballroom 5-7 (Level 3).

Lung cancer is by far the leading cause of cancer death in the United States according to the American Cancer Society with more than 143,000 deaths projected this year. More people die of lung cancer annually than breast, prostate, and colon cancers combined.

In addition to lung cancer, NanOlogy clinical programs are advancing in genitourinary gastrointestinal, peritoneal, lung, and dermal cancers.

The NanOlogy submicron particle technology platform is based on a proprietary production process that reduces the size of taxane API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The characteristics of the particles have recently been granted a composition of matter patent (US 9,814,685) valid in the US until 2036.

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About NanOlogy

NanOlogy, LLC (www.nanology.us) is a private clinical stage oncology company formed in 2015 to finance and clinically develop a patented submicron particle technology platform for local, sustained delivery of therapeutic agents aimed at increasing their value in the treatment of cancer and related conditions.

Disclaimers

This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements about our product development, business, and other activities. Such statements are subject to the risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical trial, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement and the company disclaims any intent or obligation to update these statements. NanOlogy investigational drugs have not been proven to be safe and effective as required by U.S. FDA and have not been approved by FDA or any other jurisdiction for commercial distribution.

Media Contact

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
404-245-0591

NanOlogy announces First Patient Enrolled in a Phase 1/2 Clinical Trial of NanoDoce® for Treatment of Bladder Cancer

NanOlogy announces First Patient Enrolled in a Phase 1/2 Clinical Trial of NanoDoce® for Treatment of Bladder Cancer

 

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NanOlogy announces First Patient Enrolled in a Phase 1/2 Clinical Trial of NanoDoce® for Treatment of Bladder Cancer

  • NanOlogy may offer an alternative treatment option for patients with bladder cancer

  • Investigational drug, NanoDoce, is injected locally into tumor resection bed via cystoscope guidance followed by intravesical instillation

FT. WORTH, Texas (April 9, 2019) —NanOlogy, a clinical-stage oncology company, today announced the first patient has been enrolled in a clinical trial of NanoDoce (sterile submicron particle docetaxel suspension) for treatment of bladder cancer. The Phase 1/2 dose-rising trial will evaluate the safety and preliminary efficacy of NanoDoce for patients with high-risk non-muscle invasive bladder cancer (NMIBC) and muscle invasive bladder cancer (MIBC).

In 2019, an estimated 80,000 new cases of bladder cancer will be diagnosed in the United States and an estimated 18,000 will die from the disease. Despite being one of the top five cancer diagnoses in the U.S., the last drug FDA approved for NMIBC was more than a decade ago. Of all cancers, bladder cancer tends to have the highest lifetime treatment costs due to the frequency of recurrence, progression to MIBC often requiring removal of the bladder (cystectomy), and lifetime cost of care thereafter.

In the NanOlogy clinical trial, following transurethral resection of the bladder tumor, subjects will receive direct injections of NanoDoce into the base of the index tumor resection site in combination with an intravesical instillation of NanoDoce. Additional intravesical instillations of NanoDoce will be administered to NMIBC subjects while MIBC subjects will follow institutional standard of care.

The local delivery of submicron particle docetaxel suspension [NanoDoce] represents an important step in evaluating new therapies for the treatment bladder cancer”, said Dr. Donald Lamm, MD, President of BCG Oncology and principal investigator on the trial. “Preclinical studies suggest the submicron particle technology improves both the penetration of drug into the bladder wall and its duration of activity. If this investigational drug can be proven to delay or prevent disease progression and need for cystectomy, it would contribute significantly to the quality of life of patients with this disease.”

An abstract from preclinical studies of NanoDoce was presented in February at the 2019 Genitourinary Cancer Symposium. In one of the studies, NanoDoce administered via intratumoral injection resulted in prolonged, high concentration of drug in tumor tissue, significant tumor regression, and immune cell infiltration in a xenograft animal model of transitional cell bladder carcinoma. The immune cell infiltration is of particular interest to NanOlogy for future research into the role NanoDoce may play in combination with immunoncology therapy for the treatment of advanced disease.

This work is in addition to extensive preclinical and clinical development programs underway by NanOlogy in peritoneal/ovarian cancers, prostate cancer, pancreatic cancer, pancreatic mucinous cysts, renal cell carcinoma, non-small cell lung cancer, and cutaneous metastases.

All NanOlogy investigational drugs are progressing under FDA’s streamlined 505(b)(2) regulatory pathway. The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The submicron particles are so unique they are protected under a composition of matter patent (US 9,814,685) valid until 2036, which provides new molecular entity-like advantages without the risks and timeline associated with NME drug development.

About NanOlogy

NanOlogy, LLC (www.nanology.us) is a private clinical stage oncology company formed in 2015 to finance and clinically develop a patented submicron particle technology platform for local, sustained delivery of proven drugs aimed at increasing their safety and efficacy in the treatment of cancer and related conditions.

Disclaimers

This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements about our product development, business, and other activities. Such statements are subject to the risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical trial, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement and the company disclaims any intent or obligation to update these statements. NanOlogy investigational drugs have not been proven to be safe and effective in accordance with the requirements of the U.S. FDCA and have not been approved by FDA for commercial distribution.

Media Contact

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
404-245-0591

NanOlogy to Present Positive Preclinical Data for NanoDoce® in Treatment of Uro-Oncologic Cancers at 2019 Genitourinary Cancers (ASCO-GU) Symposium

NanOlogy to Present Positive Preclinical Data for NanoDoce® in Treatment of Uro-Oncologic Cancers at 2019 Genitourinary Cancers (ASCO-GU) Symposium

 

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NanOlogy to Present Positive Preclinical Data for NanoDoce® in Treatment of Uro-Oncologic Cancers at 2019 Genitourinary Cancers (ASCO-GU) Symposium

Intratumoral delivery of NanoDoce in multiple murine xenograft studies resulted in prolonged, high concentration of drug in tumor tissue, significant tumor regression, and immune cell infiltration

FT WORTH/DALLAS, (February 13, 2019) NanOlogy, a clinical-stage oncology company, will present an abstract at the 2019 Genitourinary Cancer Symposium, co-sponsored by the American Society of Clinical Oncology (ASCO), held February 14-16, 2019 in the Moscone West Building, San Francisco.

Data from preclinical studies of NanoDoce (submicron particle docetaxel suspension) administered via intratumoral injection will be presented showing prolonged, high concentration of drug at the tumor site and significant tumor regression in multiple xenograft animal models including clear cell renal carcinoma (768-O cell line), transitional cell bladder carcinoma (UM-UC-3 cell line), and prostate carcinoma (PC-3 cell line). Abstract title, location, and times follow:

Title:                  Evaluation of submicron particle docetaxel directly injected into uro-oncologic xenografts
Poster Session:     B – Prostate Cancer; Urothelial Carcinoma; Penile, Urethral, Testicular, and Adrenal Cancers
Where:                Board E17 Abstract #360, West Building Moscone, San Francisco
When:                 Friday, February 15, 2019, 12:15 to 1:45 PM and 5:15 to 6:15 PM

Data from the preclinical studies showed that tumor volume decreases with two and three intratumoral doses of NanoDoce were significantly greater than or similar to IV docetaxel. Immunohistochemistry evaluations for the renal and bladder cancer models revealed immune cell infiltration in NanoDoce-treated animals. Drug was detected in NanoDoce-treated tumor tissue up to 50 days after administration, and at levels far greater than IV-treated animals.

Persistent, therapeutic levels of docetaxel from intratumoral NanoDoce appear to kill tumor cells through direct and indirect means. NanoDoce is known to directly inhibit tumor cell mitosis, and its persistence results in prolonged release of tumor antigen, which appears to promote indirect immune cell-mediated tumor kill.

A clinical trial in high-risk non-muscle invasive (NMIBC) and muscle invasive bladder cancer (MIBC) will begin enrollment in the first quarter of this year. Following transurethral resection of bladder tumor, subjects will receive direct injections of NanoDoce into the base of the index tumor resection site in combination with intravesical instillations of NanoDoce.

In addition, IND-enabling studies are nearing completion on NanoDoce for renal cell carcinoma to allow for a clinical trial via intratumoral injection in the second half of 2019. This work is part of an extensive preclinical and clinical development program underway by NanOlogy in peritoneal cancers, prostate cancer, pancreatic cancer, pancreatic mucinous cysts, breast cancer, non-small cell lung cancer, and cutaneous metastases.

All NanOlogy investigational drugs are progressing under FDA’s streamlined 505(b)(2) regulatory pathway. The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The submicron particles are so unique that they are protected under a composition of matter patent (US 9,814,685) valid until 2036 in the US, which provides new molecular entity-like advantages without the risks and timeline associated with NME drug development.

###

About NanOlogy
NanOlogy, LLC (www.nanology.us) is a private clinical stage oncology company formed in 2015 to finance and clinically develop a patented submicron particle technology platform for local, sustained delivery of proven drugs aimed at increasing their value in the treatment of cancer related conditions.

Disclaimer

This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements about our product development, business, and other activities. Such statements are subject to the risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical trial, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement and the company disclaims any intent or obligation to update these statements. NanOlogy investigational drugs have not been proven to be safe and effective by FDA and have not been approved by FDA for commercial distribution.

Media Contact

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
404-245-0591

NanOlogy Chief Medical Officer on Panel to Discuss Next Wave of Innovation in IO Therapy at BIO CEO & Investor Conference

NanOlogy Chief Medical Officer on Panel to Discuss Next Wave of Innovation in IO Therapy at BIO CEO & Investor Conference

 

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NanOlogy Chief Medical Officer on Panel to Discuss Next Wave of Innovation in IO Therapy at BIO CEO & Investor Conference

Company’s submicron particle investigational drugs show promise as immune system booster

FT. WORTH—February 5, 2019 — NanOlogy, a clinical-stage oncology company, announced today its Chief Medical Officer, Gere diZerega, MD, will participate on an immuno-oncology panel at the BIO CEO and Investor Conference February 11, 2019 9:00-9:55 am, Schubert Complex, 6th floor, New York Marriot Marquis.

The panel, entitledReshaping Tumor Microenvironments via Immunotherapies,” will examine the next wave of innovation in immunotherapies for leveraging knowledge of how tumor microenvironments develop to create treatments able to demonstrate more durable effects on shrinking tumors across wider ranges of patients.

Based on a proprietary production technology platform, NanOlogy is developing patented submicron particle forms of paclitaxel and docetaxel designed for local delivery directly to the disease site. Preclinical and clinical data across broad therapeutic areas, including genitourinary, gastrointestinal, peritoneal, and lung cancers indicate targeted delivery of the submicron particles of pure drug enhance tumor kill and generate significant immune stimulation with minimal systemic side effects. The data underscore the potential for NanOlogy investigational drugs to be ideal companions to IO therapy for certain solid tumors.

The company is in clinical development of its investigational drugs for prostate cancer, bladder cancer, renal cancer, peritoneal/ovarian cancers, pancreatic cancer, pancreatic mucinous cysts, and lung cancer.

BioSpace recently named NanOlogy to its list of Top 20 Life Sciences companies to watch in 2019.

Joining Dr. diZerega on the panel are: Moderator: Jotin Marango, MD, PhD, Managing Director, Senior Research Analyst, ROTH Capitol; Lewis H. Bender, Chief Executive Officer, Intensity Therapeutics; Sabine Chlosta, MD, PhD, Chief Medical Officer, Triumvira Therapeutics; and Eric Falcand, Vice President of Business Development & Licensing, Servier.

NanOlogy investigational drugs are progressing under the FDA streamlined 505(b) (2) regulatory pathway. The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The submicron particles are so unique that they are protected under a composition of matter patent (US 9,814,685) valid until 2036, which provides new molecular entity-like advantages without the risks and timeline associated with NME drug development.

###

About NanOlogy
NanOlogy, LLC (www.nanology.us) is a private clinical stage oncology company formed in 2015 to finance and clinically develop a patented submicron particle technology platform for local, sustained delivery of proven drugs aimed at increasing their value in the treatment of cancer related conditions.

Disclaimer
This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements about our product development, business, and other activities. Such statements are subject to the risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical trial, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement and the company disclaims any intent or obligation to update these statements. NanOlogy investigational drugs have not been proven to be safe and effective in accordance with the requirements of the U.S. FDCA and have not been approved by FDA for commercial distribution.

 

Media Contact

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
404-245-0591

Positive Preclinical Findings from Inhaled NanoPac® Lung Study Published in the Journal of Aerosol Medicine and Pulmonary Drug Delivery

Positive Preclinical Findings from Inhaled NanoPac® Lung Study Published in the Journal of Aerosol Medicine and Pulmonary Drug Delivery

 

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Positive Preclinical Findings from Inhaled NanoPac® Lung Study Published in the Journal of Aerosol Medicine and Pulmonary Drug Delivery

Preclinical Study Demonstrated Inhaled NanoPac Shows Prolonged Retention and Limited Systemic Exposure

 

FORT WORTH/DALLAS, (October 30, 2018) — NanOlogy, a clinical-stage oncology development company, announced today that positive findings from a pharmacokinetic (PK) preclinical study of inhaled NanoPac (submicron particle paclitaxel for nebulized inhalation) was published in an article entitled “Pharmacokinetic Profile of Inhaled Submicron Particle Paclitaxel (NanoPac) in a Rodent Model,” in the Journal of Aerosol Medicine and Pulmonary Drug Delivery.

The preclinical PK study examined the retention of NanoPac in rat lung following a single inhalation via a nose-only exposure chamber. Data showed measurable amounts of drug in the lung at the end of the 14-day study with examined tissue being microscopically indistinguishable from normal lung tissue. The 14-day retention of drug in lung tissue came as a surprise to researchers who had never seen this length of retention before.

A follow-on preclinical study examined the therapeutic effect of inhaled NanoPac using an orthotopic model of non-small cell lung cancer (NSCLC). Histologic analysis revealed NanoPac achieved a significant decrease in primitive tumor cell population as well as significant tumor regression. Data from this study was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting this past June in an abstract entitled “NanoPac Inhalation Treatment of NSCLC in a Nude Rat Orthotopic Lung Cancer Model”. Immunohistochemistry stains of NanoPac treated animals demonstrated immune cell infiltration that suggested immune-mediated tumor kill in addition to a direct tumoricidal effect.

IND-enabling studies are underway on NanoPac to allow for a clinical trial in 2019. This work is in addition to an extensive preclinical and clinical development program underway by NanOlogy in peritoneal cancers, prostate cancer, pancreatic cancer, pancreatic mucinous cysts, bladder cancer, renal cancer, breast cancer, and cutaneous metastases.

All NanOlogy investigational drugs are progressing under FDA’s streamlined 505(b)(2) regulatory pathway. The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The submicron particles are so unique that they are protected under a composition of matter patent (US 9,814,685) valid until 2036, which provides new molecular entity-like advantages without the risks and timeline associated with NME drug development.

###

About NanOlogy
NanOlogy, LLC (www.nanology.us) is a private clinical stage oncology company formed in 2015 to finance and clinically develop a patented submicron particle technology platform for local, sustained delivery of proven drugs aimed at increasing their safety and efficacy in the treatment of cancer and related conditions.

Disclaimer
This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements about our product development, business, and other activities. Such statements are subject to the risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical trial, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement and the company disclaims any intent or obligation to update these statements. NanOlogy investigational drugs have not been proven to be safe and effective in accordance with the requirements of the U.S. FDCA and have not been approved by FDA for commercial distribution.

 

Media Contact

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
404-245-0591

DFB Soria Completes a Phase 2 Clinical Trial of Submicron Particle Paclitaxel Anhydrous Ointment for Actinic Keratosis

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DFB Soria Completes a Phase 2 Clinical Trial of Submicron Particle Paclitaxel Anhydrous Ointment for Actinic Keratosis

Soria investigational drug provides evidence of actinic keratosis (AK) lesion reduction without the local irritation of approved topical AK treatment products

FT.WORTH, Texas & DALLAS– DFB Soria, a DFB Pharmaceuticals company, today announced completion of a dose-rising clinical trial of a topically applied submicron particle paclitaxel suspended in a pharmaceutically elegant, preservative-free anhydrous base. The trial was designed to evaluate safety and preliminary efficacy of four strengths of the product applied twice daily for 28 days. Results from the trial show evidence of AK lesion reduction in size and count, dose response, and minimal local irritation or other side effects.

Actinic Keratosis affects 58 million Americans and is caused by exposure to the sun and other sources of UV radiation. The condition is responsible for 8 million visits to dermatologists or primary care physicians in the US annually. Left untreated, AK can progress to squamous cell carcinoma (SCC), the second most common form of skin cancer. Each year, more than one million people are diagnosed with SCC and as many as 9,000 people die from the disease. IV Paclitaxel is approved by FDA for the treatment of advanced SCC, which provided Soria the rationale for developing its topical product for AK.

“The most widely prescribed topical treatment for AK contains 5-fluorouracil, which causes severe dermal irritation and significantly decreases quality of life for several weeks during use,” said Gere diZerega, MD, VP of Medical Affairs. “Our goal was to demonstrate our product would result in AK lesion reduction without the severe irritation that limits other topical products. We now may identify a pharma partner or proceed ourselves as the results from this trial allow us to move forward with a dose confirmation trial followed by a pivotal phase 3 trial if successful.”

The submicron particle paclitaxel contained in the Soria product is produced by a proprietary production technology that reduces the size of unprocessed paclitaxel API crystals up to 400 times into stable, uncoated particles of pure drug with exponentially increased surface area and unique geometry. The particles are so unique they have been granted a composition of matter patent (US 9,814,685) that is valid until 2036. This provides the product new molecular entity-like IP advantages with a streamlined 505(b)2 FDA regulatory pathway.

NanOlogy, LLC, a company related to Soria, is also underway on a phase1/2 clinical trial of a similar topical product for the treatment of cutaneous metastases, which is expected to complete in early 2019. Cutaneous metastases are skin lesions secondary to certain metastatic cancers and represents an unmet medical need because no approved topical treatments exist for common forms of the condition.

The company is evaluating options for bringing both products to regulatory approval including sale or license to a dermatology-focused company or continued internal investment.

NanOlogy has an exclusive license for the submicron particle production technology with investigational drugs currently in clinical trials for peritoneal malignancies (with orphan drug status), prostate cancer, pancreatic cancer, and pancreatic mucinous cysts. In addition, clinical trials are planned by NanOlogy in bladder cancer in late 2018 and in lung cancer and renal cancer in 2019.

About Soria and NanOlogy

DFB Soria, LLC (www.dfbsoria.com) is owned and operated by DFB Pharmaceuticals LLC. Soria developed its submicron particle paclitaxel anhydrous ointment under an exclusive worldwide license from CritiTech, Inc. for dermatology. NanOlogy, LLCis a private clinical stage pharmaceutical company formed in 2015 to finance and clinically develop the submicron particle technology platform for local, sustained delivery of chemotherapeutic agents aimed at increasing their safety and efficacy in the treatment of cancer and related conditions.

 

Disclaimer

This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements about our product development, business, and other activities. Such statements are subject to the risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical trial, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement and the company disclaims any intent or obligation to update these statements. NanOlogy and Soria investigational drugs have not been proven to be safe and effective in accordance with the requirements of the U.S. FDCA and have not been approved by U.S. FDA for commercial distribution.

Media Contacts

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
404-245-0591

NanOlogy Adds Clinical Trial Sites for Phase 2 Clinical Trials of NanoPac® in Pancreatic Cancer and Pancreatic Mucinous Cysts

NanOlogy Adds Clinical Trial Sites for Phase 2 Clinical Trials of NanoPac® in Pancreatic Cancer and Pancreatic Mucinous Cysts

 

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NanOlogy Adds Clinical Trial Sites for Phase 2 Clinical Trials of NanoPac® in Pancreatic Cancer and Pancreatic Mucinous Cysts

Preliminary Data from Both Trials Show NanoPac Well-Tolerated via Intratumoral and Intracystic Injection

 

FORT WORTH/DALLAS, (August 8, 2018) — NanOlogy LLC, a clinical-stage pharmaceutical development company, today announced the opening of three new sites for its Phase 2 clinical trials of NanoPac (submicron particle paclitaxel) sterile suspension in the treatment of pancreatic adenocarcinoma and mucinous cystic neoplasms (MCNs) of the pancreas.

The new sites for the pancreatic cancer trial are Parkview Regional Medical Center in Fort Wayne, IN with Neil Sharma, MD serving as principal investigator (PI) and Texas Tech University Health Sciences Center in El Paso with Antonio Mendoza-Ladd, MD the PI. Parkview will also be a new site for the Phase 2 MCN trial with Dr. Sharma serving as PI.

Parkview and Texas Tech join two other sites for the pancreatic cancer trial: Baylor St. Luke’s Medical Center in Houston, TX and Cedars-Sinai Medical Center in Los Angeles. The PIs for the Baylor and Cedars-Sinai sites are Mohamed Othman, MD and Simon Lo, MD, respectively.

In addition to Parkview, the other sites for the Phase 2 MCN trial are Baylor St. Luke’s Medical Center with Dr. Othman as the PI and University of Chicago Medical Center with Irving Waxman, MD, serving as PI.

To date, the independent Data and Safety Monitoring Boards for both trials have found no drug-related safety concerns and both studies have dose-escalated in accordance with their clinical protocols.

NanoPac is part of a broad submicron particle technology platform developed by NanOlogy. The technology reduces paclitaxel crystals to submicron particles for direct injection into the pancreatic cancer tumors and MCNs. The particles are so unique in terms of size and surface area that they have recently been granted a composition of matter patent valid until 2036.

Intratumoral injection of NanoPac, rather than systemic infusion of paclitaxel, enables local delivery of a more concentrated dose at the site of disease that kills pancreatic cancer cells over a longer period without adverse systemic side effects.

If successful in clinical trials, intracystic delivery of a high, locally sustained concentration of NanoPac for patients with high risk MCN’s could serve as an alternative to surgery, which is the primary treatment.

An estimated 55,000 new cases of pancreatic cancer will be diagnosed in 2018 and 44,000 people will die from the disease. Despite being relatively rare, pancreatic cancer is the third leading cause of cancer death in the US with a survival rate of only 25% at one year and less than 10% at five years.

Pancreatic cysts affect an estimated 3 million Americans, and most are benign. However, a subset of pancreatic cysts called MCN’s are deemed to be at high risk for progression to pancreatic cancer and prevalence estimates range from 60,000 to 180,000 people.

The Phase 2 trials in pancreatic cancer and pancreatic mucinous cysts are part of an extensive clinical development program underway by NanOlogy. Local administration of NanoPac also is being evaluated in Phase 2 clinical trials for ovarian cancer (with orphan drug designation) and prostate cancer. A clinical trial of NanoDoce (submicron particle docetaxel sterile suspension) is planned to begin in in late 2018 for bladder cancer and in 2019 for renal cancer.

In addition, NanOlogy is progressing a clinical trial of a submicron particle paclitaxel topical anhydrous ointment for cutaneous metastases. An inhaled version of NanoPac in preclinical lung cancer studies demonstrated prolonged retention of drug in lung tissue and significant tumor regression without adverse drug-related observations. The positive findings will be used to support an IND to begin clinical trials of inhaled NanoPac for treatment of non-small cell lung cancer.

###

About NanOlogy

NanOlogy, LLC (www.nanology.us) is a clinical stage pharmaceutical company formed by DFB Pharmaceuticals, LLC of Fort Worth, TX, CritiTech, Inc. of Lawrence, KS, and US Biotest, Inc. of San Luis Obispo, CA, to finance and clinically develop a patented submicron particle technology platform for local, sustained delivery of proven drugs aimed at increasing their safety and efficacy in the treatment of cancer and related conditions.

 

Disclaimer

This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding our product development, business, and other activities. Such statements are subject to risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement and NanOlogy disclaims any intent or obligation to update these statements. NanOlogy investigational drugs have not been proven safe and effective in accordance with the requirements of the FDCA and are not approved by FDA for commercial distribution.

Media Contacts

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
404-245-0591

NanOlogy to Unveil Positive Preclinical Data for Inhaled NanoPac® in Treatment of Lung Cancer at 2018 ASCO Annual Meeting

 

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NanOlogyto Unveil Positive Preclinical Data for Inhaled NanoPac® In Treatment of Lung Cancer at 2018 ASCO Annual Meeting

Update – 6/4/18:  Link to NanOlogy Poster presented at 2018 ASCO Annual Meeting

 

  • Studies of Inhaled NanoPac Show Prolonged Retention in the Lung, Decreased Primitive Tumor cells, and Increased Tumor Regression

FT. WORTH/DALLAS, (May 29, 2018) BUSINESS WIRE — NanOlogy LLC, a clinical-stage pharmaceutical development company, will present data from preclinical studies of inhaled NanoPac (submicron particle paclitaxel) showing prolonged retention of drug in lung tissue and significant tumor regression without adverse drug-related observations in an orthotopic animal model of non-small cell lung cancer (NSCLC).

The data will be presented in an abstract entitled “NanoPac Inhalation Treatment of NSCLC in a Nude Rat Orthotopic Lung Cancer Model” during the American Society of Clinical Oncology (ASCO) Annual Meeting on Sunday, June 3rd, from 8:00 AM to 11:30 AM in Hall A of McCormick Place in Chicago.

An initial preclinical pharmacokinetic (PK) study examined the retention of NanoPac in rat lung tissue following a single inhalation via a nose-only exposure chamber. Data showed measurable amounts of drug in the lung at the end of the 14-day study with examined tissue being microscopically indistinguishable from normal lung tissue.

A preclinical study followed to examine the therapeutic effect of inhaled NanoPac using an orthotopic model of NSCLC. Histologic analysis revealed NanoPac achieved a significant decrease in primitive tumor cell population as well as significant tumor regression.

Gere diZerega, MD, VP of Medical Affairs, said, “In our initial PK study, inhaled NanoPac resulted in longer lung retention of drug at a higher concentration compared to systemically administered paclitaxel. The evidence seen in our preclinical PK and efficacy studies has given us the confidence to move forward with IND-enabling studies in preparation for clinical trials.”

Lung cancer is by far the leading cause of cancer death according to the American Cancer Society with more than 154,000 deaths expected this year. More people die of lung cancer every year than breast, prostate, and colon cancers combined.

The preclinical lung cancer studies are in addition to an extensive clinical development program underway by NanOlogy. Local administration of NanoPac is also being evaluated in Phase 2 clinical trials for ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer, and pancreatic mucinous cysts. A clinical trial of NanoDoce® (submicron particle docetaxel sterile suspension) is planned to begin in September for bladder cancer.

NanOlogy is also progressing a clinical trial of a submicron particle paclitaxel topical anhydrous ointment for cutaneous metastases.

All NanOlogy investigational drugs are progressing under FDA’s streamlined 505(b)(2) regulatory pathway. The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into stable submicron particles of pure drug with exponentially increased surface area and unique geometry. The submicron particles are so unique that they are protected under a composition of matter patent (US 9,814,685) valid until 2036, which provides NME-like advantages without the risk and timeline associated with new molecular entity drug development.

###

About NanOlogy

NanOlogy, LLC (www.nanology.us) is a clinical stage pharmaceutical company formed by DFB Pharmaceuticals, LLC of Fort Worth, TX, CritiTech, Inc. of Lawrence, KS, and US Biotest, Inc. of San Luis Obispo, CA, to finance and clinically develop a patented submicron particle technology platform for local, sustained delivery of proven drugs aimed at increasing their safety and efficacy in the treatment of cancer and related conditions.

Disclaimer

This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements about our product development, business, and other activities. Such statements are subject to the risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical trial, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement and the company disclaims any intent or obligation to update these statements. NanOlogy investigational drugs have not been proven to be safe and effective in accordance with the requirements of the U.S. FDCA and have not been approved by FDA for commercial distribution.

Media Contacts

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
404-245-0591

NanOlogy Completes Dose Escalation Portion of Phase 2 Clinical Trial of NanoPac® for Treatment of Prostate Cancer

 

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NanOlogy Completes Dose Escalation Portion of Phase 2 Clinical Trial of NanoPac® for Treatment of Prostate Cancer

 

  • Intratumoral injection of three concentrations of NanoPac successfully completed across a total of 9 patients
  • Highest concentration of NanoPac continues into dose confirmation phase of trial as no drug-related local or systemic side effects observed
  • Histologic examination of prostate tissue shows tumor regression

 

FT.WORTH/DALLAS, (April 30, 2018) — NanOlogy LLC, a clinical-stage pharmaceutical development company, has completed the dose escalation phase of an open-label clinical trial of NanoPac (submicron particle paclitaxel sterile suspension) injected directly into the tumor area for treatment of prostate cancer. Successful completion of the dose escalation phase has allowed the highest concentration of NanoPac to begin the dose confirmation phase of the trial, which will continue to generate data on safety and tumor response.

The Phase 2a trial is enrolling patients with local prostate cancer scheduled for prostatectomy. In the trial, patients receive intratumoral injection of NanoPac 28 days before surgery. Tumor volume and prostate tissue biopsy taken prior to NanoPac administration is compared to tumor volume and tissue after surgery.

In the dose escalation phase to determine highest concentration of drug which can be safely administered, 6 mg/mL, 10 mg/mL, 15 mg/mL concentrations of NanoPac were each injected into three patient cohorts followed by safety review for each cohort. No drug related serious adverse events were reported in any of the cohorts and preliminary data show evidence of tumor reduction and tumor cell death.

“NanoPac is injected directly into the cancerous lobe of the prostate under MRI/TRUS fusion guidance”, said Andre Abreu, MD, Assistant Professor of Clinical Urology, Co-director of Image-Guided Surgery & Focal Therapy of Prostate and Kidney Cancer at the University of Southern California’s Institute of Urology. “The drug injected locally has been well tolerated to date and we have progressed into the dose confirmation phase of the trial to further assess safety and tumor response.”

“NanoPac is injected directly into the cancerous lobe of the prostate under MRI/TRUS fusion guidance”, said Andre Abreu, MD, Assistant Professor of Clinical Urology, Co-director of Image-Guided Surgery & Focal Therapy of Prostate and Kidney Cancer at the University of Southern California’s Institute of Urology. “The drug injected locally has been well tolerated to date and we have progressed into the dose confirmation phase of the trial to further assess safety and tumor response.”

The dose confirmation phase has begun and will enroll 9 additional patients for a total of 18 patients who received direct injection of NanoPac 28 days prior to their scheduled prostatectomy. In addition to assessing safety and tolerability, tumor size and histologic evidence of tumor response will be evaluated, and local lymph nodes will be analyzed to investigate potential lymphatic transport of NanoPac. Completion of the clinical trial and final report are expected in the third quarter of 2018.

Prostate cancer affects an estimated 3 million men in the US with about 160,000 new cases and 27,000 deaths annually. Patients at higher risk for disease progression or those in whom the cancer has spread may face surgical removal of the prostate or radiation therapy. Unfortunately, these patients often suffer incontinence or impotence, which significantly decrease quality of life.

Dr. Abreu added, “If we are successful, we may offer a treatment option for moderate or high-risk patients with localized or non-metastatic disease potentially providing better oncologic outcomes while minimizing side-effects of chemotherapy, and therefore maintaining quality of life.”

The prostate cancer study is part of an extensive clinical development program underway by NanOlogy. Local administration of NanoPac is also being evaluated in Phase 2 clinical trials for ovarian cancer (with orphan drug designation), pancreatic cancer, and pancreatic mucinous cysts.

An inhaled version of NanoPac for lung cancer has demonstrated prolonged lung tissue residence time and tumor regression in preclinical studies and a clinical trial of NanoDoce® (submicron particle docetaxel sterile suspension) is planned to begin in September for bladder cancer.

In addition, NanOlogy is progressing a clinical trial of a submicron particle paclitaxel topical anhydrous ointment for cutaneous metastases. The topical product was developed by NanOlogy affiliate DFB Soria, who has also recently completed a Phase 2 clinical trial of the product in actinic keratosis, which showed lesion reduction and no drug-related local or systemic adverse events.

All the NanOlogy and Soria products are progressing under FDA’s streamlined 505(b)(2) regulatory pathway. The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into stable, naked submicron particles of pure drug with exponentially increased surface area and unique geometry. The particles are so unique they have recently been granted a composition of matter patent (US 9,814,685) which provides NME-like advantages without the risk and timeline associated with new molecular entity drug development.

###

About NanOlogy

NanOlogy, LLC (www.nanology.us) is a clinical stage pharmaceutical company formed by DFB Pharmaceuticals, LLC of Fort Worth, TX, CritiTech, Inc. of Lawrence, KS, and US Biotest, Inc. of San Luis Obispo, CA, to finance and clinically develop a patented submicron particle technology platform for local, sustained delivery of proven drugs aimed at increasing their safety and efficacy in the treatment of cancer and related conditions.

Disclaimer

This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements about our product development, business, and other activities. Such statements are subject to the risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical trial, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement. DFB disclaims any intent or obligation to update these statements. NanOlogy and Soria investigational drugs have not been proven to be safe and effective in accordance with the requirements of the U.S. FDCA and have not been approved by FDA for commercial distribution.

Media Contacts

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
404-245-0591

NanOlogy to Present Abstract on Preclinical Study of Nebulized NanoPac for Lung Cancer at 2018 ASCO Annual Meeting

 

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NanOlogy to Present Abstract on Preclinical Study of Nebulized NanoPac® for Lung Cancer at 2018 ASCO Annual Meeting.

Presentation on Sunday, June 3 at 8 am in Chicago’s McCormick Place

FT.WORTH/DALLAS, (April 25, 2018) — NanOlogy LLC, a clinical-stage pharmaceutical development company, will present an abstract detailing results of a preclinical trial of a nebulized form of NanoPac (submicron particle paclitaxel) at the American Society of Clinical Oncology 2018 Annual Meeting in Chicago, June 1 – 5.

The abstract, “NanoPac Inhalation Treatment of NSCLC in a Nude Rat Orthotopic Lung Cancer Model,” will be presented Sunday, June 3, 8 am to 11:30 am, in Hall A of the McCormick Place.

NanOlogy is currently conducting Phase 2 clinical trials of NanoPac sterile suspension for ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer and pancreatic mucinous cysts.

In addition, NanOlogy and affiliate, DFB Soria, are progressing clinical trials of Soria-developed SOR007, a topical ointment form of NanoPac for cutaneous metastases and actinic keratosis. Clinical trials for NanoDoce, (submicron particle docetaxel) are planned in 2018 pending IND approval.

The NanOlogy submicron particle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into patent-pending, stable, naked submicron particles with exponentially increased surface area and unique geometry. The technology enables delivery of concentrated doses of paclitaxel and docetaxel directly into the disease site without the serious adverse side effects associated with systemic infusions of the chemotherapy.

 

###

About NanOlogy and DFB Soria
NanOlogy, LLC (www.nanology.us) is a company formed between DFB Pharmaceuticals, LLC, CritiTech Inc., and US Biotest, Inc. to finance and develop a submicron particle technology platform to transform systemic chemotherapy through local delivery to improve the lives of patients with cancer and other serious illnesses. DFB Soria, LLC is owned and operated by DFB. Soria developed the topical formula under an exclusive worldwide license of the submicron particle production technology from CritiTech for certain fields outside of oncology including dermatology.

Disclaimer
This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding NanOlogy and Soria product development, business, and other activities. Such statements are subject to risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement and NanOlogy disclaims any intent or obligation to update these statements. The Soria and NanOlogy investigational new drugs have not yet been proven to be safe and effective in accordance with the requirements of the U.S. FDCA and are not approved by FDA for commercial distribution.

Media Contacts

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
404-245-0591

NanOlogy Announces First Patient Enrolled in a Phase 2 Clinical Trial for Cutaneous Metastases and DFB Soria Provides an Update on AK Trial

 

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NanOlogy Announces First Patient Enrolled in a Phase 2 Clinical Trial for Cutaneous Metastases and DFB Soria Provides an Update on AK Trial

 

  • New study of submicron particle paclitaxel topical product seeks to address unmet medical need in treatment of cutaneous metastases
  • Affiliate, DFB Soria, completes enrollment of Phase 2 actinic keratosis (AK) trial with evidence of lesion reduction and minimal side effects
  • Company Representatives in San Diego during AAD annual meeting

 

DALLAS/FT.WORTH, (February 14, 2018) —NanOlogy, a clinical-stage pharmaceutical development company and affiliate of DFB Pharmaceuticals, today announced enrollment of the first patient in a Phase 1/2 clinical trial of a submicron particle paclitaxel topical anhydrous ointment for the treatment of cutaneous metastases. The open label dose escalating trial of three different strengths of the product will be followed by dose confirmation to evaluate safety and preliminary safety. NanOlogy has licensed the topical formulation for use in oncology from DFB Soria, which is owned and operated by DFB.

Cutaneous metastases occur when cells from cancer elsewhere in the body spread or metastasize to the skin. These metastatic skin lesions can appear as firm round or oval nodules, or red patches, which may ulcerate through the skin causing discomfort and disfigurement. Affecting as many as 700,000 late-stage cancer patients, the condition may originate from breast, lung, colon, or other types of cancers and adds to the distress faced by these patients.

“Treatment of metastatic skin lesions is widely seen as an unmet medical need as no approved topical treatments exist for lesions caused by the most common metastatic diseases.” said Dr. Sant Chawla of Sarcoma Oncology Research Center. “There is a strong scientific rationale for local treatment with a topical formulation because systemic paclitaxel is often used to treat the underlying cancer. We are hopeful that topical use of the formulation will be effective without causing the debilitating side effects of systemic chemotherapy.”

Because no other topical treatment options exist for many patients suffering from cutaneous metastases, the company will seek to gain FDA fast track status if the results of this trial are successful.

Separately, Soria has completed enrollment in a Phase 2 actinic keratosis (AK) clinical trial that is evaluating different strengths of the topical formulation for safety and efficacy. Results from the randomized, double-blind, placebo-controlled trial are expected in April but preliminary blinded observations are promising.

AK is a precancerous condition caused by exposure to the sun, affecting an estimated 58 million Americans. AK can progress to cutaneous squamous cell carcinoma (CSCC), the second most common form of skin cancer. More than 1 million people are diagnosed with CSCC each year, and as many as 9,000 people die from the disease. The most widely prescribed topical treatment for AK contains 5-fluorouracil, which can cause severe local irritation and inflammation.

“Our topical product has caused minimal local irritation and negligible systemic absorption in clinical trials.” said Managing Director, Marc Iacobucci. “Confirmation of lesion reduction in this clinical trial will allow selection of the most efficacious strength to move forward into pivotal trials.”

The key advance of the proprietary production technology is a patented process that reduces the size of taxane API crystals by up to 400 times into stable, naked submicron particles with exponentially increased surface area and unique geometry. The submicron particles, which are so unique they have recently been granted a composition of matter patent, are then suspended in a patent-pending topical anhydrous base, which has successfully shown penetration of drug through the epidermis into the dermis.

NanOlogy is also advancing four clinical trials of another product, NanoPac® (submicron particle paclitaxel sterile suspension), for evaluation in ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer, and pancreatic mucinous cysts. A clinical trial of NanoDoce® (submicron particle docetaxel sterile suspension) is expected to begin in bladder cancer in mid-2018.

Preclinical studies of a form of NanoPac delivered via nebulized inhalation for lung cancer have demonstrated significant tumor reduction and greater than 14-day retention in lung tissue with no gross or histological abnormalities.

Representatives from the company will be in San Diego during the American Academy of Dermatology Annual Meeting to meet with companies interested in partnering opportunities.

###

About NanOlogy and DFB Soria
NanOlogy, LLC (www.nanology.us) is a company formed between DFB Pharmaceuticals, LLC, CritiTech Inc., and US Biotest, Inc. to finance and develop a submicron particle technology platform to transform systemic chemotherapy through local delivery to improve the lives of patients with cancer and other serious illnesses. DFB Soria, LLC is owned and operated by DFB. Soria developed the topical formula under an exclusive worldwide license of the submicron particle production technology from CritiTech for certain fields outside of oncology including dermatology.

Disclaimer
This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding NanOlogy and Soria product development, business, and other activities. Such statements are subject to risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement and NanOlogy disclaims any intent or obligation to update these statements. The Soria and NanOlogy investigational new drugs have not yet been proven to be safe and effective in accordance with the requirements of the U.S. FDCA and are not approved by FDA for commercial distribution.

Media Contacts

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
404-245-0591

NanOlogy to Update Clinical Program Transforming Treatment of Cancer at BIO CEO and Investor Conference

 

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NanOlogy to Update Clinical Program Transforming Treatment of Cancer at BIO CEO and Investor Conference

 

  • Company has six Phase 2 trials underway for cancer and related illnesses via local delivery of submicron particle chemotherapeutic platform
  • Preliminary data showing tumor reduction and no drug-related adverse events
  • Composition patent valid until 2036 provides NME-like advantages with streamlined 505(b)2 regulatory pathway

DALLAS/FORT WORTH, TX-February 5, 2018 – NanOlogy, a clinical stage pharmaceutical development company, announced today that Gere diZerega, MD, VP of Medical Affairs, will present at BIO CEO & Investor Conference, February 12, 2018, at 3:15PM EST in the Brecht room of the New York Marriott Marquis.

Dr. diZerega will share promising preliminary data from the NanOlogy clinical development programs. The company is developing a submicron particle technology platform for local delivery of chemotherapeutic agents for the treatment of cancer and related illnesses via intratumoral, intracystic, intraperitoneal, and topical administration.

“The NanOlogy submicron particle platform may provide more effective therapies for multiple indications either as early first line treatments or in combination regimens,” said lead scientific advisor Maurie Markman, MD, President of Medicine and Science, Cancer Treatment Centers of America®. “Early trial results indicate that the platform may enable local delivery of large, sustained amounts of the drug at the site of disease, thereby reducing systemic exposure and systemic side effects.”

Clinical Programs
NanOlogy has four Phase 2 clinical trials underway for NanoPac®, a sterile suspension of submicron particle paclitaxel, in ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer, and pancreatic mucinous cysts. NanOlogy also is conducting a Phase 2 trial of SOR007, submicron particle paclitaxel suspended in a topical anhydrous base, for cutaneous metastases, while NanOlogy affiliate, DFB Soria, has a Phase 2 trial of SOR007 nearing completion for actinic keratosis. In 2018, a clinical trial is planned in bladder cancer for NanoDoce®, a sterile suspension of the submicron particle docetaxel, pending IND approval. 

Preclinical
In addition, NanoPac for nebulized inhalation has shown tumor reduction in a preclinical lung cancer study after pharmacokinetic studies demonstrated an unprecedented 14-day retention of drug in lung tissue with no gross or histologic abnormalities in the tissue.

Patent Portfolio
The NanOlogy submicron particle technology platform is protected by an extensive intellectual property (IP) portfolio covering production processes, uses, formulations, and specifications, as well as composition under US patent 9,814,685 entitled Taxane Particles and Their Use valid until June 2036 covering particle size, density, surface area, drug dissolution, and other aspects. NanOlogy investigational drugs are being developed under FDA’s streamlined 505(b)2 pathway. Coupled with the composition patent, and expanding IP portfolio, the company enjoys NME (new molecular entity) – like advantages without the corresponding risk and timeline.

NanOlogy expects results from its clinical trials in 2018 and during this time will be exploring options to progress its drug candidates to NDA submission, market approval, and commercial distribution.

###

About NanOlogy
NanOlogy, LLC (www.nanology.us) is a company formed by DFB Pharmaceuticals, LLC of Fort Worth, TX, CritiTech, Inc. of Lawrence, KS, and US Biotest, Inc. of San Luis Obispo, CA, to finance and clinically develop a patented submicron particle technology platform for local, sustained delivery of proven drugs aimed at increasing their safety and efficacy in the treatment of cancer and related conditions.

Disclaimer
This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements about our product development, business, and other activities. Such statements are subject to the risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical trial, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement. DFB disclaims any intent or obligation to update these statements. NanOlogy and Soria investigational drugs have not been proven to be safe and effective in accordance with the requirements of the U.S. FDCA and have not been approved by FDA for commercial distribution.

Contacts

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
404-245-0591

NanOlogy to Present Update on Cancer Treatment Clinical Program at Biotech Showcase in San Francisco

 

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NanOlogy to Present Update on Cancer Treatment Clinical Program at Biotech Showcase in San Francisco

Company has six Phase 2 trials underway and a composition patent just granted on its submicron particle active pharmaceutical ingredients

FORT WORTH, TX– January 2, 2018 – NanOlogy, a clinical stage pharmaceutical development company, announced today that Gere diZerega, MD, VP of Medical Affairs, will present at Biotech Showcase, January 8, 2018, at 3:45 pm in Franciscan room D on the Ballroom Level of https://ebdgroup.knect365.com/biotech-showcase/the Hilton San Francisco Union Square Hotel.

Dr. diZerega will present an update on the status of the NanOlogy clinical development programs. The company is developing a submicron particle technology platform for local delivery of chemotherapeutic agents in the treatment of cancer and related illnesses via intratumoral, intracystic, intraperitoneal, and topical administration.

Clinical Programs
NanOlogy has four Phase 2 clinical trials underway for NanoPac®, a sterile suspension of submicron particle paclitaxel, in ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer, and pancreatic mucinous cysts. NanOlogy also is conducting a Phase 2 trial of SOR007, submicron particle paclitaxel suspended in a topical anhydrous base, for cutaneous metastases, while NanOlogy affiliate, DFB Soria, has a Phase 2 trial of SOR007 nearing completion for actinic keratosis.

Preclinical
In addition, NanoPac for nebulized inhalation has shown tumor reduction in a preclinical lung cancer study after pharmacokinetic studies demonstrated more than 14 day retention of drug in lung tissue. In 2018, clinical trials are planned for NanoDoce®, a sterile suspension of the submicron particle docetaxel, pending IND approval.

Patent Portfolio
The NanOlogy submicron particle technology platform is protected by an extensive intellectual property (IP) portfolio covering production processes, uses, formulations, and specifications, as well as composition under US patent 9,814,685 entitled Taxane Particles and Their Use granted on November 14, 2017 covering particle size, density, surface area, drug dissolution, and other aspects. “NanOlogy investigational drugs are being developed under FDA’s streamlined 505(b) 2 pathway” said Michael Baltezor, PhD, head of product development. “Coupled with a composition patent on our particles, we now enjoy NME [new molecular entity] – like IP advantages without the corresponding risk and time associated with NME development.”

NanOlogy expects results from its clinical trials in 2018 and during this time will be identifying a pharmaceutical or strategic investment partner to progress its drug candidates to NDA submission, market approval, and commercial distribution.

###

About NanOlogy
NanOlogy, LLC (www.nanology.us) is a company formed by DFB Pharmaceuticals, LLC of Fort Worth, TX, CritiTech, Inc. of Lawrence, KS, and US Biotest, Inc. of San Luis Obispo, CA, to finance and clinically develop a patented submicron particle technology platform for local, sustained delivery of proven drugs aimed at increasing their safety and efficacy in the treatment of cancer and related conditions.

Disclaimer
This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements about our product development, business, and other activities. Such statements are subject to the risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical trial, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement. DFB disclaims any intent or obligation to update these statements. NanOlogy and Soria investigational drugs have not been proven to be safe and effective in accordance with the requirements of the FDCA and have not been approved by FDA for commercial distribution.

Contacts

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
404-245-0591

NanOlogy Announces First Patient Enrolled in a Pancreatic Cancer Phase 2 Clinical Trial of NanoPac® Adding to Trials in Prostate and Ovarian Cancers

 

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NanOlogy Announces First Patient Enrolled in a Pancreatic Cancer Phase 2 Clinical Trial of NanoPac® Adding to Trials in Prostate and Ovarian Cancers

NanOlogy chemotherapy drug injected directly into pancreatic tumor

FORT WORTH, Texas & DALLAS–(December 18, 2017)–NanOlogy LLC, a clinical-stage pharmaceutical development company, today announced the first patient has been enrolled in a clinical trial of NanoPac® (nanoparticle paclitaxel) sterile suspension administered intratumorally in patients with locally advanced pancreatic adenocarcinoma. The Phase 2a dose-rising trial will evaluate the safety and preliminary efficacy of NanoPac delivered directly into the tumor by endoscopic ultrasound-guided fine needle injection in patients who have completed current standard of care treatment prior to trial entry.

NanoPac is part of an extensive submicron technology platform developed by NanOlogy. Gere diZerega, MD, VP of Medical Affairs, will present an overview of the platform and an update of the clinical program at Biotech Showcase™, on January 8, 2018 at 3:45PM in Franciscan room D (Ballroom Level) of the Hilton San Francisco Union Square.

In 2017, an estimated 54,000 new cases of pancreatic cancer will be diagnosed in the U.S. and 43,000 people will die from the disease. Despite being relatively rare, pancreatic cancer is the third leading cause of cancer death in the USA with a survival rate of only 25% at one year and less than 10% at five years. Pancreatic cancer is so deadly because it is rarely diagnosed at an early stage while it is still local, and the disease tends to be aggressive and resistant to systemic chemotherapy. Recent advances in abdominal imaging techniques hold the promise for earlier diagnosis of pancreatic cancer and the ability to treat the disease before it spreads to other parts of the body.

“The advanced endoscopy team at Baylor College of Medicine and St Luke’s Medical Center performed the first endoscopic ultrasound-guided intratumoral injection of NanoPac for locally advanced pancreatic cancer last Friday,” said Dr. Mohamed Othman, MD, Director of Advanced Endoscopy and Associate Professor of Medicine at Baylor College of Medicine in Houston, TX. “The team is hopeful that this approach may offer a more potent and less toxic alternative for patients with locally advanced disease.”

“The targeted administration of submicron particle paclitaxel sterile suspension [NanoPac] by endoscopic ultrasound (EUS) represents an important step in the fight against pancreatic cancer,” said Jacques Van Dam, MD, PhD, Professor of Medicine and Clinical Scholar at the University of Southern California’s Keck School of Medicine, and Principle Investigator for this multicenter trial. “Pancreatic cancer patients, their families, and their physicians recognize all too well the limitations of current therapies. Delivering NanoPac directly into the tumor may eliminate many of the toxic side effects of standard chemotherapy, while providing a higher concentration of drug directly to its intended target.”

NanOlogy has a broad clinical development program underway for NanoPac sterile suspension, including clinical trials in ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer, and pancreatic mucinous cysts. In addition, NanOlogy and affiliate DFB Soria are progressing clinical trials for Soria-developed SOR007 (nanoparticle paclitaxel) ointment in cutaneous metastases and actinic keratosis. Clinical trials for NanoDoce® (nanoparticle docetaxel) are planned in 2018 pending IND approval. An inhaled version of NanoPac has shown evidence of tumor reduction in a preclinical lung cancer study after PK studies demonstrated retention of drug in lung tissues for more than 14 days following nebulized inhalation and no abnormalities within the trachea or lung upon gross and histologic exam.

Starting with the world’s most prescribed systemic chemotherapeutic agents, the patented NanOlogy submicron particle production technology reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into patented, stable, naked submicron particles with exponentially increased surface area and unique geometry. Unlike conventional nanoparticles, which use coating or carrier agents for stability, NanoPac and NanoDoce particles are stable in their naked form and suspended prior to use without such agents for local delivery to the site of disease.

About NanOlogy

NanOlogy, LLC (www.nanology.us) is a collaboration of DFB Pharmaceuticals, LLC of Fort Worth, TX, CritiTech, Inc. of Lawrence, KS, and US Biotest, Inc. of San Luis Obispo, CA, to finance and clinically develop a patented submicron production technology platform for local, sustained delivery of proven drugs aimed at increasing their safety and efficacy in the treatment of cancer and related illnesses.

Disclaimer

This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding our product development, business, and other activities. Such statements are subject to risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement and NanOlogy disclaims any intent or obligation to update these statements. NanOlogy and Soria investigational drugs have not been proven safe and effective in accordance with the requirements of the FDCA and are not approved by FDA for commercial distribution.

Contacts

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
404-245-0591

NanOlogy Announces First Patient Enrolled in a Phase 2 Clinical Trial of NanoPac® for Treatment of Mucinous Cysts of the Pancreas

 

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NanOlogy Announces First Patient Enrolled in a Phase 2 Clinical Trial of NanoPac® for Treatment of Mucinous Cysts of the Pancreas 

 NanOlogy may offer a nonsurgical treatment option for patients at high cancer risk

FORT WORTH/DALLAS, (November 7, 2017) — NanOlogy LLC, a clinical-stage pharmaceutical development company, today announced the first patient has been enrolled in a clinical trial of NanoPac® (nanoparticle paclitaxel) sterile suspension for treatment of mucinous cystic neoplasms (MCNs) of the pancreas. The Phase 2 dose-rising trial will evaluate the safety and preliminary efficacy of NanoPac delivered directly into MCNs by endoscopic ultrasound-guided fine needle injection.

NanoPac is part of an extensive submicron technology platform developed by NanOlogy. Gere diZerega, MD, VP of Medical Affairs, will present an overview of the platform and an update of the clinical program during the Biotech Showcase™, January 8-10, 2018, in San Francisco.

“There is no approved drug treatment for patients with MCNs who are at high risk for progression to cancer,” said Dr. diZerega. “This clinical trial is the first study in humans to examine whether NanoPac injected intracystically will safely chemically ablate the cyst with a high locally sustained concentration of the drug.”

Pancreatic cysts are diagnosed in more than a 500,000 people annually in the US and their diagnoses are increasing as advances in imaging technology have made abdominal imaging more common. MCNs are a subset of neoplastic pancreatic cysts and may progress to pancreatic cancer, which kills 90% of patients within five years of diagnosis. Patients with MCNs deemed at high risk for progression may undergo surgical resection of the pancreas to remove the cyst. This surgical procedure is complicated, however, and is associated with mortality and morbidity rates of 2% and 30% respectively. If successful, intracystic injection of NanoPac would represent an alternative to surgery for these patients.

“If we are successful, we may offer the first drug treatment for high-risk MCNs, which would help fill an unmet need in this increasingly diagnosed condition,” said Marc Iacobucci, a Managing Director of NanOlogy.

NanOlogy has a broad clinical development program underway for NanoPac sterile suspension, including clinical trials in ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer, and pancreatic mucinous cysts. In addition, NanOlogy and affiliate, DFB Soria, are progressing clinical trials for Soria-developed SOR007 (nanoparticle paclitaxel) ointment in cutaneous metastases and actinic keratosis. Clinical trials for NanoDoce® (nanoparticle docetaxel) are planned in 2018 pending IND approval. An inhaled version of NanoPac is in a preclinical pharmacology study for lung cancer after pharmacokinetic studies demonstrated retention of drug in lung tissues for more than 14 days following nebulized inhalation. In addition, no abnormalities were seen within the trachea or lung upon gross and histologic exam.

Starting with the world’s most prescribed systemic chemotherapeutic agents, the patented NanOlogy submicron particle production technology reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into patent-pending, stable, naked submicron particles with exponentially increased surface area and unique geometry. Unlike nanoparticles, which use coating or carrier agents for stability, NanoPac and NanoDoce are stable in their naked form and suspended prior to use without such agents for local delivery to the site of disease.

###

About NanOlogy 

NanOlogy, LLC (www.nanology.us) is a collaboration of DFB Pharmaceuticals, LLC of Fort Worth, TX, CritiTech, Inc. of Lawrence, KS, and US Biotest, Inc. of San Luis Obispo, CA, to finance and clinically develop a patented submicron production technology platform for local, sustained delivery of proven drugs aimed at increasing their safety and efficacy in the treatment of cancer and related conditions.

Disclaimer 

This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding NanOlogy and Soria product development, business, and other activities. Such statements are subject to risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement and NanOlogy disclaims any intent or obligation to update these statements. NanOlogy and Soria investigational new drugs have not yet been proven to be safe and effective in accordance with the requirements of the Federal Food, Drug, and Cosmetic Act and are not approved by FDA for commercial distribution.

Contacts

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
404-245-0591

NanOlogy Announces First Patient Enrolled in a Phase 2 Clinical Trial of NanoPac® for Treatment of Prostate Cancer

 

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NanOlogy Announces First Patient Enrolled in a Phase 2 Clinical Trial of NanoPac® for Treatment of Prostate Cancer

NanOlogy to Present at BIO Investor Forum on October 17 in San Francisco

 

FT.WORTH/DALLAS, (October 16, 2017) — NanOlogy LLC, a clinical-stage pharmaceutical development company, today announced the first patient has been enrolled in a clinical trial of NanoPac® (nanoparticle paclitaxel) sterile suspension administered into the prostate for treatment of prostate cancer. Part of a broad nanoparticle technology platform developed by the company, NanoPac will be evaluated for safety and preliminary efficacy in a dose-rising Phase 2(a) clinical trial following intratumoral injection of the prostate via transrectal ultrasound guidance in patients four weeks prior to radical prostatectomy. Gere diZerega, MD, VP of Medical Affairs, will present an overview of the NanOlogy platform and clinical program at BIO Investor Forum, October 17, 2017 9:45AM, at the San Francisco Westin St. Francis Hotel in Elizabethan D presentation room.

“Systemically administered paclitaxel has been shown to be effective for prostate cancer but is limited to metastatic disease,” said Dr. diZerega. “This clinical trial is the first study in humans to examine whether NanoPac injected intratumorally will effectively and safely treat the tumor with a high locally sustained concentration of the drug.”

Prostate cancer affects an estimated 3 million men in the US and about 27,000 die annually from the disease. In 2017, about 161,000 new cases of prostate cancer will be diagnosed and newly diagnosed patients considered at low risk may undergo “watchful waiting” or “active surveillance” to monitor but not treat the disease. Patients at higher risk for disease progression or those in whom the cancer has spread have a number of treatment options including prostatectomy. Unfortunately, prostatectomy can cause side effects like incontinence or impotence, which significantly decrease the patient’s quality of life.

“If we are successful, we may offer a treatment option for moderate or high risk patients with localized or non-metastatic disease without a negative impact on quality of life,” said Shelagh Verco, Clinical Director of NanOlogy.

NanOlogy has an extensive clinical development program underway for NanoPac sterile suspension, including clinical trials in ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer, and pancreatic mucinous cysts. In addition, NanOlogy and affiliate, DFB Soria, are progressing clinical trials for Soria-developed SOR007 (nanoparticle paclitaxel) ointment in cutaneous metastases and actinic keratosis. Clinical trials for NanoDoce® (nanoparticle docetaxel) are planned in 2018 pending IND approval. An inhaled version of NanoPac is in a preclinical efficacy study for lung cancer after pharmacokinetics studies demonstrated retention of drug in lung tissues for more than 14 days following nebulized delivery and no abnormalities were seen within the trachea or lung upon gross and histologic exam.

The NanOlogy nanoparticle technology platform is based on a patented production process that reduces the size of paclitaxel and docetaxel API crystals by up to 400 times into patent-pending, stable, naked nanoparticles with exponentially increased surface area and unique geometry. Unlike other nanoparticles, which use coating agents for stability, NanoPac and NanoDoce are stable in their naked form and suspended prior to use in simple vehicles without coating agents.

This open-label, dose-rising, Phase 2a trial will enroll up to 30 patients with local prostate cancer scheduled for prostatectomy. Four weeks prior to scheduled radical prostatectomy, patients will receive NanoPac injected under transrectal ultrasound guidance directly into the lobe of the prostate with the dominant tumor. In addition to assessing safety and tolerability of NanoPac, tumor size change and histologic changes will be evaluated. In addition, local lymph nodes will be analyzed to investigate potential lymphatic transport of NanoPac.

###

About NanOlogy

NanOlogy, LLC (www.nanology.us) is a company formed by DFB Pharmaceuticals, LLC of Fort Worth, TX, CritiTech, Inc. of Lawrence, KS, and US Biotest, Inc. of San Luis Obispo, CA, to finance and clinically develop a patented nanoparticle technology platform for local, sustained delivery of proven drugs aimed at increasing their safety and efficacy in the treatment of cancer and related conditions.

About DFB Pharmaceuticals

DFB Pharmaceuticals, LLC (www.dfb.com) is a private Texas investment group with an entrepreneurial drive for developing new healthcare products and businesses. Founded in 1990, DFB and its principals have realized more than $1.5 billion in value through startups, strategic acquisition and sale of companies and technologies, internal product development, brand optimization, and operations in the healthcare industry.

Disclaimer

Disclaimer

This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding NanOlogy and Soria product development, business, and other activities. Such statements are subject to risks and uncertainties inherent in any pharmaceutical development program which may cause actual results to differ materially due to developmental, clinical, regulatory, market, competitive, technological, or other factors. All forward-looking statements are made as of the date of this announcement and NanOlogy disclaims any intent or obligation to update these statements. NanOlogy and Soria investigational new drugs have not yet been proven to be safe and effective in accordance with the requirements of the Federal Food, Drug, and Cosmetic Act and are not approved by FDA for commercial distribution.

Contacts

Dan Eramian
Opus Biotech Communications
danieleramian@comcast.net
425-306-8716

Charles Craig
Opus Biotech Communications
charles.s.craig@gmail.com
404-245-0591