FORT WORTH, Texas--(BUSINESS WIRE)--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 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.
NanOlogy has four Phase 2 clinical trials underway for NanoPac®, a sterile suspension of submicron particle, 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 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.
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.
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 FDCA and have not been approved by FDA for commercial distribution.