Archive for the Soria Category

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.

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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 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.

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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 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.

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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 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.

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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.

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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

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 Ovarian Cancer

 

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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

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

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)

 

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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.

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.

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

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