NexMed, Inc. (NASDAQ: NEXM), a specialty CRO with a pipeline of products based on the NexACT ® technology, today announced that the Company has filed an Investigational New Drug (IND) application with the U.S. Food & Drug Administration (FDA) for a Phase II trial of its recently acquired cancer drug candidate PrevOnco™, in combination with doxorubicin in patients with advanced, unresectable hepatocellular carcinoma (HCC). The FDA has 30 days to comment on the IND before NexMed can proceed with human testing. PrevOnco (the anti-ulcer compound, lansoprazole, approved under the name Prevacid® and marketed in the U.S. by Takeda Pharmaceuticals North America, Inc.) had been under development by FasTrack Pharmaceuticals, Inc. for the treatment of solid tumors, in particular, for the treatment of HCC. FasTrack received orphan Drug status for PrevOnco from the FDA in August 2008. In vitro and in vivo pre-clinical 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. NexMed recently acquired PrevOnco from San Diego-based FasTrack Pharmaceuticals, which was spun out of Bio-Quant in October 2009; NexMed acquired Bio-Quant in December 2009. As an upfront payment, NexMed paid approximately $205,000 in the form of the cancellation of indebtedness owed by FasTrack to Bio-Quant. In addition, FasTrack and NexMed will share equally in any future revenues, including payments received from potential licensing partners, after first deducting NexMed’s future development expenses, including a 15% premium. NexMed’s prospective, open label, single-arm, multicenter Phase II trial will assess the safety and efficacy of lansoprazole and doxorubicin in patients with advanced unresectable HCC at up to 10 study sites throughout the U.S. The primary objective of the study is to assess the response rate to doxorubicin and lansoprazole. Subjects will be treated with oral lansoprazole 90mg twice daily and intravenous (IV) doxorubicin 60 mg/m 2 administered every 21 days. Subjects will continue to receive IV doxorubicin plus lansoprazole, if tolerated, up to a maximum of six consecutive cycles of doxorubicin, as long as there is no evidence of progressive disease. A total of between 15 and 70 subjects are expected to be enrolled in the study for a period of up to 12 months in the absence of disease progression or intolerance. Total study duration is anticipated to be one to three years, depending on the rate of enrollment and number of patients enrolled. Commenting on today’s news, Dr. Bassam Damaj, President and Chief Executive Officer of NexMed, stated, “Acquiring the rights to PrevOnco represents NexMed’s entrance into oncology and adds an important product candidate to our pipeline. With a solid safety profile, generated from over 15 years of human use of lansoprazol for the treatment of ulcers, and early indications of anti-cancer activity observed in pre-clinical studies, we believe that PrevOnco is a strong candidate for development with NexMed’s proprietary NexACT drug delivery technology as a second generation compound. Our recent filing of the IND with the FDA is a major milestone for NexMed, and we look forward to initiation of the Phase II trial.”
Dr. Ziad Mirza, Chief Executive Officer of FasTrack, stated, “We are excited to partner our company’s lead product candidate with NexMed. The expertise of Dr. Damaj and his team in the field of oncology will be invaluable in taking this program to the next level and we look forward to starting the pending Phase 2 trials.”About Hepatocellular Carcinoma (HCC) Hepatocellular carcinoma (HCC) is the seventh most common cancer in the world, with a higher 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 relatively 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 i n 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. About FasTrack Pharmaceuticals, Inc. Based in San Diego, CA and founded in 2009, FasTrack Pharmaceuticals, Inc. is a privately-held specialty pharmaceutical company engaged in the development of innovative human therapeutic drugs to treat life threatening diseases, including cancer and autoimmune diseases. The Company’s lead product candidate, PrevOnco, is under development for the treatment of various solid tumors. Forward-Looking Statement Safe Harbor 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 including, but not limited to, the ability to successfully launch and complete the planned PrevOnco Phase II trial and the ability to reproduce pre-clinical findings in clinical trials.