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.

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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

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

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

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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

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.

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