Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that it has enrolled the first patient in a U.S. Phase 2 trial evaluating NOV-205 as monotherapy in up to 40 chronic hepatitis C genotype 1 patients who previously failed treatment with pegylated interferon plus ribavirin. Details of the trial design may be found on www.clinicaltrials.gov – ID: NCT01058512, or via a link at www.novelos.com ‘Clinical Trials’ section.
“The safety data from the U.S. Phase 1b short-term dosing trial support initiation of this Phase 2 trial, evaluating both dose escalation and extended dosing with NOV-205. Because NOV-205 is not a direct anti-viral agent, we believe the Phase 2 trial is more likely to demonstrate clinical activity,” said Dr. Raymond Koff, Novelos’ expert Medical Advisor for hepatitis. “We look forward to further evaluating the clinical activity of NOV-205 in chronic hepatitis C non-responders – a large patient population for which there is no established, beneficial therapy.”
About Hepatitis C
The World Health Organization estimates that chronic hepatitis C affects 170 million people worldwide. In the U.S., according to the Centers for Disease Control and Prevention (CDC), an estimated 4.1 million persons are affected. Chronic infection can progress to cirrhosis, end-stage liver disease and hepatocellular carcinoma. While there are varying estimates about the size of the global market for hepatitis C drugs, the current global market is believed to be in excess of $3 billion per year. Currently about 8,000-10,000 hepatitis C-related deaths occur annually in the U.S. and this could double over the next 10 to 20 years. The current standard-of-care drugs for chronic hepatitis C – the combination of pegylated interferon and ribavirin – are expensive, have significant toxicities, are difficult to tolerate for many patients and have limited long-term efficacy in genotype 1 patients (the most common HCV genotype seen in the U.S. and much of the world). Approximately 50% of the genotype 1 patients do not benefit from treatment with pegylated interferon plus ribavirin, and currently there is no approved standard of care to treat these non-responding chronic hepatitis C patients.