NexMed, Inc. (NASDAQ: NEXMD) is currently trading at $3.40, up $1.20 or 54.55%. NexMed 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 throughout 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.
In its most recent press release on June 28th, the company announced that it will present its PrevOnco® Data at the International Liver Cancer Association (ILCA) 4th Annual Conference from September 10-12, 2010 in Montreal. PrevOnco is NexMed’s proprietary cancer treatment for patients with advanced, unresectable hepatocellular carcinoma (HCC), or liver cancer. 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; hence, the need for a drug such as NexMed’s PrevOnco.
PrevOnco was granted orphan drug status by the U.S. Food & Drug Administration (FDA) in August 2008. It 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.”
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