EpiCept Corporation, a company focused on the development and commercialization of pharmaceutical products for the treatment of pain and cancer, has announced that new preclinical research for its apoptosis inhibitor drug candidate EP1013 (now renamed F573) has concluded that F573 is a new therapeutic drug candidate for the treatment of late-stage viral infection-induced hepatitis.

The data were published in the Chinese Pharmacological Bulletin (2102 Volume 28 (1):136-139). F573 was discovered by EpiCept and licensed to GNI Group Ltd. in 2008 for clinical development in Asia, Australia and New Zealand.

F573 delivered intravenously demonstrated a therapeutic effect in a study involving 60 mice with acute liver injury, including a reduction in TNF-a and cell apoptosis. GNI Group Ltd. also noted that F573 reduced mice mortality caused by acute liver injury and that these animal studies provide important proof and direction for future human studies.

EpiCept president and CEO Jack Talley commented, "This is the first published evidence of F573's activity in viral hepatitis, an inflammation of the liver caused mainly by three specific viruses (hepatitis A, B and C). According to the C. Everett Koop Institute, 3-5 million Americans are infected with hepatitis C alone, with at least 170 million people infected globally. GNI's continued progress against this disease may enable us to advance the development of the compound in other territories, particularly North America and Europe."

As part of its license agreement with GNI Group Ltd., EpiCept is eligible to receive milestone payments of more than $12 million based on the clinical advancement of F573 in Asia, Australia and New Zealand, as well as royalties on commercial sales. EpiCept retains the commercial rights to F573/EP1013 in all other markets. The next potential milestone payment would occur in conjunction with initiation of a phase I trial in any of the territories outlined in the agreement. In July 2011, Shanghai Genomics, a wholly owned subsidiary of GNI Group Ltd., filed an Investigational New Drug (IND) application for F573 in China.

F573 is a di-peptide small-molecule compound with a potent inhibitory effect on caspases, a class of enzymes involved in cell death and inflammation. Drug efficacy has been shown in animal models relating to liver failure, brain ischemia and myocardial infarction. GNI Group Ltd. has secured a series of patent rights for F573 in China, Japan other key territories from EpiCept Corporation to develop this drug for liver diseases.