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.”
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.
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.
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.
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.
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.