NexMed, Inc. (NASDAQ: NEXM), a specialty CRO with a pipeline of products based on the NexACT ® technology, today announced that the U.S. Food & Drug Administration (FDA) has cleared the Company to proceed with the proposed Phase 2 trial of PrevOnco ™, its proprietary cancer treatment for patients with advanced, unresectable hepatocellular carcinoma (HCC), or liver cancer. The FDA granted PrevOnco ™ orphan drug status in August 2008, and in March 2010, NexMed filed its Investigational New Drug (IND) application for the product candidate.
The Company also noted that in IND review communication, the FDA has given 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).
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.
Commenting on today’s news, Dr. Bassam Damaj, President and Chief Executive Officer of NexMed, stated, “We are very pleased that the FDA agreed with our protocol for the HCC Phase 2 trial for PrevOnco ™ as a first-line therapy for HCC. Additionally, we are actively assessing the suggestion made by the FDA to move directly into a Phase 3 trial, by studying PrevOnco ™ in combination with Doxorubicin as a second-line therapy for patients who have failed NEXAVAR ® therapy. Following this path could be very advantageous for NexMed since advancing the drug directly into a Phase 3 study would save us at least 12-24 months in development time.”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.