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

On February 13, 2019 / NanOlogy Press Release

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.

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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 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

On February 5, 2019 / NanOlogy Press Release

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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, 6^th floor, New York Marriot Marquis.

The panel, entitled “Reshaping 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.

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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

On October 30, 2018 / NanOlogy Press Release

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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.

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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 proven drugs aimed at increasing their safety and efficacy in the treatment of cancer and related conditions.

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

On September 18, 2018 / NanOlogy Press Release, Soria

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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

On August 8, 2018 / NanOlogy Press Release

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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.

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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

On May 29, 2018 / NanOlogy Press Release

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NanOlogy^™to 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 3^rd, 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

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

On April 30, 2018 / NanOlogy Press Release

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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

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

On April 25, 2018 / NanOlogy Press Release

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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.

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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

On February 14, 2018 / NanOlogy Press Release, Soria

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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.

###

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

On February 5, 2018 / NanOlogy Press Release, Soria

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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

On January 3, 2018 / NanOlogy Press Release, Soria

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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.

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.

###

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

On December 18, 2017 / NanOlogy Press Release, Soria

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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

On November 7, 2017 / NanOlogy Press Release, Soria

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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

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

On October 16, 2017 / NanOlogy Press Release, Soria

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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.

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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

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 Ovarian Cancer

On October 9, 2017 / NanOlogy Press Release, Soria

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

Intraperitoneal NanoPac transforms systemic administration into local delivery

DALLAS/FT.WORTH, (October 9, 2017) — NanOlogy LLC , a clinical-stage pharmaceutical development company, today announced enrollment of the first patient in a Phase 2 clinical trial of intraperitoneally (IP) administered NanoPac^® (nanoparticle paclitaxel) sterile suspension in patients with ovarian cancer. Part of a broad nanoparticle technology platform developed by the company, NanoPac will be evaluated for safety and efficacy after IP instillation of NanoPac at the end of cytoreductive (debulking) surgery.

“Systemically administered paclitaxel has been shown to be effective in ovarian cancer but is limited by its adverse effects,” said Gere diZerega, MD, VP of Medical Affairs. “We are attempting to show that a single, IP-instilled dose of NanoPac will effectively treat the cancer with high locally sustained concentrations of the drug and no contribution to systemic adverse effects.”

Ovarian cancer is newly diagnosed in more than 22,000 women annually and almost 70% of these women will die from the disease. As a result, ovarian cancer is the fifth leading cause of cancer-related deaths in women. First line treatment is surgery to remove as much of the tumor as possible followed by systemic chemotherapy to attempt to eradicate any of the cancer that remains.

“If successful, we may add to the newer treatment options that are just becoming available and ideally improve the prognosis and quality of life for patients diagnosed with ovarian cancer,” said Marc Iacobucci 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 pharmacokinetic studies demonstrated retention of drug in lung tissues for more than 14 days following nebulized delivery and no abnormalities 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 patented, 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.

###

About NanOlogy

About DFB Pharmaceuticals

Disclaimer

This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding Soria and NanOlogy 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 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

DFB Soria Gives Update on Enrollment in Phase 2 Clinical Trial of SOR007 (Nanoparticle Paclitaxel) Ointment for Actinic Keratosis (AK)

On September 26, 2017 / NanOlogy Press Release, Soria

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DFB Soria Gives Update on Enrollment in Phase 2 Clinical Trial of SOR007 (Nanoparticle Paclitaxel) Ointment for Actinic Keratosis (AK)

AK can lead to the second most common form of skin cancer

DALLAS/FT.WORTH, (September 26, 2017) —DFB Soria, a clinical-stage pharmaceutical development company, and an affiliate of NanOlogy™, today announced completion of the second of four patient cohorts enrolled in a Phase 2 actinic keratosis (AK) clinical trial of a topical ointment containing nanoparticle paclitaxel formed by a proprietary production process. Identified as SOR007, the ointment is being evaluated topically in a dose escalating trial for safety and preliminary efficacy.

“The most widely prescribed topical treatment for AK is 5-fluorouracil, which causes severe dermal irritation and significantly decreases the patient’s quality of life for several weeks.” said Gere diZerega, MD, Soria VP of Medical Affairs. “Preclinical dermal irritation studies and a Phase 1 clinical trial of SOR007 showed minimal dermal irritation and negligible systemic absorption, and formed the basis for FDA approving the clinical protocol for our AK trial.”

AK is a precancerous condition caused primarily by exposure to the sun, and affects an estimated 58 million Americans. If left untreated, AK can progress to cutaneous squamous cell carcinoma (CSCC), the second most common form of skin cancer. More than one million people are diagnosed with CSCC each year, and as many as 9,000 people die from the disease. Paclitaxel administered systemically is effective in the treatment of advanced CSCC but can cause systemic adverse effects.

“Our goal is to demonstrate that SOR007 is effective without the severe topical irritation that limits other AK products.” said Maxwell Lea of Soria. “Successful results from this clinical trial will allow selection of the most efficacious SOR007 concentration to move forward into phase 3-enabling clinical trials.”

Nanoparticle paclitaxel contained in SOR007 is produced by a proprietary nanoparticle production technology that reduces the size of unprocessed paclitaxel API crystals up to 400 times into patented, stable, naked nanoparticles with exponentially increased surface area and unique geometry. NanoPac is then suspended in a topical anhydrous base, which has successfully shown penetration of the drug through the epidermis into the dermis. Both the nanoparticle and the ointment are patent pending.

Nanology and Soria share a common nanoparticle technology platform that is currently in six clinical trials for evaluation in ovarian cancer (with orphan drug status), prostate cancer,

pancreatic cancer, pancreatic mucinous cysts, cutaneous metastases, and actinic keratosis. In addition, preclinical studies are underway for lung cancer and bladder cancer.

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About Soria and NanOlogy

DFB Soria, LLC (www.dfbsoria.com) is owned and operated by DFB Pharmaceuticals, LLC. Soria, an affiliate of NanOlogy, developed SOR007 under an exclusive worldwide license of the nanoparticle production technology from CritiTech, Inc. for certain fields outside of oncology including dermatology. NanOlogy, LLC (www.nanology.us) is a company formed between DFB, CritiTech, and US Biotest, Inc. to finance and develop a nanoparticle technology platform to transform systemic chemotherapy through local delivery to improve the lives of patients with cancer and other serious illnesses.

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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 Pharmaceuticals Forms NanOlogy™ for Clinical Development of Naked Nanoparticle Platform to Treat Cancer and Related Illnesses

On September 12, 2017 / NanOlogy Press Release

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DFB Pharmaceuticals Forms NanOlogy™ for Clinical Development of Naked Nanoparticle Platform to Treat Cancer and Related Illnesses

Systemic chemotherapy transformed into local delivery with potential for greater efficacy and safety to treat cancer and other serious illnesses.

FORT WORTH (September 12, 2017) – DFB Pharmaceuticals, a private investment and development group, in collaboration with CritiTech and US Biotest, has formed NanOlogy to finance and develop a breakthrough technology platform to produce unique, patented, naked nanoparticle forms of paclitaxel and docetaxel for local delivery with the potential for greater efficacy and safety to treat cancer and other serious illnesses.

NanOlogy has developed sterile suspension forms of NanoPac® (nanoparticle paclitaxel) and NanoDoce® (nanoparticle docetaxel) as well as an inhaled form of NanoPac. A topical form identified as SOR007 (nanoparticle paclitaxel) ointment was developed by affiliate, DFB Soria, and licensed to NanOlogy for clinical development in oncology.

The sterile suspension has been designed to be injected directly into tumors, cysts, peritoneum, or other body cavities, where studies have demonstrated the nanoparticles remain and slowly release for four weeks, resulting in prolonged local exposure. In contrast, systemic forms of taxanes remain at the treatment site for a short time as they are rapidly cleared from the body.

NanOlogy is progressing a broad clinical development program for NanoPac in 2017 that includes clinical trial evaluation of its sterile suspension in ovarian cancer (with orphan drug designation), prostate cancer, pancreatic cancer, and pancreatic mucinous cysts. In addition, clinical trial evaluation of SOR007 ointment is underway for actinic keratosis (under affiliate, Soria), and is expected to begin in the fourth quarter for cutaneous metastases. Clinical trials in various cancers are planned in 2018 for NanoDoce pending approval of its IND, and the inhaled version of NanoPac is in a preclinical efficacy study for lung cancer.

“Systemic administration of paclitaxel and docetaxel is associated with significant adverse effects. Physicians and scientists have known for decades that paclitaxel and docetaxel are effective cancer killing agents, and have long searched for ways to preferentially retain high concentration of drug at the treatment site to increase efficacy.” said Maurie Markman, MD, President of Medicine and Science, Cancer Treatment Centers of America®. “The NanOlogy technology may offer a solution by enabling local delivery of large, sustained amounts of the drug at the site of disease, and reducing systemic exposure and systemic side effects.”

NanoPac and NanoDoce are manufactured by a patented nanoparticle production technology platform that reduces the size of unprocessed paclitaxel and docetaxel crystals by up to 400 times into stable, naked nanoparticles with an exponential increase in surface area and unique geometry. Unlike other nanoparticles, which require coating agents to keep them stable, the patented NanOlogy nanoparticles are stable in their naked form and suspended prior to use in simple vehicles without coating agents.

“We are excited about the potential of this technology platform to bring breakthrough therapies to patients with a wide range of cancers and other serious illnesses.” commented H. Paul Dorman, Chairman and CEO of NanOlogy.

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About NanOlogy

About DFB Pharmaceuticals

About CritiTech

CritiTech, Inc. (www.crititech.com) is a private Kansas particle engineering company focused on developing new drugs and improving existing drugs. Using the company’s proprietary Supercritical Precipitation Technology (SCP Technology) CritiTech specializes in optimizing the delivery of challenging drug substances, potent molecules and poorly soluble compounds. In addition, CritiTech uses its SCP Technology to improve the efficacy, drug delivery options, dosing regimen and pharmacokinetics of a wide variety of drugs, including oral, injectable, and inhaled drugs.

About US Biotest

US Biotest, Inc. is a private California company dedicated to the development of therapeutics to address serious unmet medical needs. Building on strong relationships with industry experts, academic institutions, and leading physicians, the company provides product development strategy and support. US Biotest manages efficient delivery of programs from nonclinical through late-stage clinical trials.

Disclaimer

This announcement contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended, including statements about NanOlogy 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 investigational new drugs have not been approved by FDA for commercial distribution. They have not yet been proven to be safe and effective in accordance with the requirements of the Federal Food, Drug, and Cosmetic Act.

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

Archive for the NanOlogy Press Release Category

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