NanOlogy Announces First Patient Enrolled In A Phase II Clinical Trial Of Nanopac For Ovarian Cancer
Published: Oct 09, 2017
Intraperitoneal NanoPac transforms systemic administration into local delivery
DALLAS & FT. WORTH, Texas--(BUSINESS WIRE)--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.
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.
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.