NexMed to Present PrevOnco™ Data at ILCA Annual ConferencePremier Event for Liver Cancer Research
SAN DIEGO-- (BUSINESS WIRE)-- NexMed, Inc. (Nasdaq: NEXMD), a specialty CRO with a pipeline of product candidates based on the NexACT® technology, today announced that the Company will present data at the International Liver Cancer Association (ILCA) Fourth Annual Conference from September 10-12, 2010 in Montreal, Canada. The presentation, entitled, "PrevOnco™ Exhibits In Vitro Cytolytic Activity, Prolongs Survival in Kidney Cancer and Leukemia Models and Reduces Tumor Growth Rates Alone and in Concert in a Liver Cancer Model," is scheduled to be presented by Bassam Damaj, Ph.D., President and Chief Executive Officer of NexMed, on Saturday, September 11, 2010 from 2:30 - 4:30 p.m.
PrevOnco™ is NexMed's proprietary cancer treatment for patients with advanced, unresectable hepatocellular carcinoma (HCC), or liver cancer, and was granted orphan drug status by the U.S. Food & Drug Administration (FDA) in August 2008. PrevOnco™ incorporates lansoprazole, which is the generic anti-ulcer compound approved under the name Prevacid® and marketed in the U.S. by Takeda Pharmaceuticals North America, Inc. In vitro and in vivo data generated to date has demonstrated the ability of lansoprazole to inhibit tumor cell growth and enhance survival in mouse models of cancer alone, and in combination with Doxorubicin.
In March 2010, NexMed filed an Investigation New Drug (IND) application for PrevOnco™. In April 2010, the FDA cleared the Company's protocol to test the product in a Phase 2 study as a first line therapy for HCC. In the same IND communication, the FDA gave NexMed the opportunity to move PrevOnco™ directly into a Phase 3 trial that would support marketing approval, subject to positive study results. In order to pursue this regulatory path, NexMed would need to expand the proposed Phase 2 study design to use PrevOnco™ in combination with Doxorubicin as a second-line therapy for patients who have failed NEXAVAR® , the currently marketed first-line anticancer treatment for patients with either HCC or advanced renal cell carcinoma (cancer of the kidney).
Dr. Damaj stated, "This is the first time that PrevOnco™ data will be presented for peer review at a leading industry conference. The product has generated significant interest, as patients who have HCC and fail the currently marketed first-line treatment currently have no other viable alternative. Given the potential of this product candidate, we remain in active discussions with the FDA about the protocol design for testing our product in a larger scale Phase 3 study."
About Hepatocellular Carcinoma (HCC)
Hepatocellular carcinoma (HCC) is the seventh most common cancer in the world, with a high incidence in China and other Asian countries. Although uncommon in the U.S., there are a reported 8,500 to 11,000 new cases diagnosed each year, comprising 2% of all malignancies. Cases in the U.S. occur primarily in men of Chinese descent, a subpopulation which has a high incidence of viral hepatitis - a known risk factor for HCC.
About NexMed, Inc.
NexMed is the largest specialty CRO based in San Diego, CA and is one of the industry's most experienced CROs for in vitro and in vivo pharmacology services and research models. The Company's goal is to generate revenues from the growth of its Discovery Pre-clinical CRO business, while aggressively seeking to monetize its proprietary NexACT® drug delivery technology through out-licensing agreements with pharmaceutical and biotechnology companies, worldwide. At the same time, NexMed is actively pursuing partnering opportunities for its NexACT-based treatments for onychomycosis, psoriasis, sexual dysfunction and cancer. For further information on NexMed and its subsidiaries, visit the following websites: www.nexmed.com and www.bio-quant.com.
Forward-Looking Statement Safe Harbor for NexMed
Statements under the Private Securities Litigation Reform Act: with the exception of the historical information contained in this release, the matters described herein contain forward-looking statements that involve risks and uncertainties that may individually or mutually impact the matters herein described for a variety of reasons that are outside the control of the Company. For example, and without limitation, there can be no assurance that PrevOnco™ will be successful in clinical testing, or the FDA will approve it for marketing.
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