Novelos Therapeutics Enrolls 1st Patient in Phase 2 Hepatitis C Trial with NOV-205
Trial Conclusion Expected in 2011; Preliminary Results Expected 3Q 2010
NEWTON, Mass.–(BUSINESS WIRE)–Novelos Therapeutics, Inc. (OTCBB: NVLT – News), 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.
About NOV-205 for Hepatitis
NOV-205 is a unique, injectable, small-molecule proprietary formulation of oxidized glutathione and inosine that acts as a hepatoprotective agent with immunomodulating and anti-inflammatory properties. A U.S. Phase 1b trial in chronic hepatitis C patients who previously failed treatment with pegylated interferon plus ribavirin was successfully concluded based on demonstration of a favorable safety profile. Previously, NOV-205 demonstrated clinical activity (reduced viral load and improved liver function) and safety as monotherapy for treatment of hepatitis B and C in a total of 178 patients from Russia. The ongoing U.S. Phase 2 trial aims to expand the safety database for NOV-205 and assess its effects on the same efficacy-related endpoints using a comparable dosing regimen, although this trial is being conducted in a more difficult to treat interferon/ribavirin non-responder patient population.
About Novelos Therapeutics, Inc.
Novelos Therapeutics, Inc. is a biopharmaceutical company commercializing oxidized glutathione-based compounds for the treatment of cancer and hepatitis. Novelos is seeking to build a pipeline through licensing or acquiring clinical stage compounds or technologies for oncology indications. Our lead compound, NOV-002, has been administered to approximately 1,000 cancer patients in clinical trials and is in Phase 2 development for solid tumors in combination with chemotherapy. Novelos has a partnership with Mundipharma, an independent associated company of Purdue Pharma, to develop and commercialize NOV-002 in Europe and Asia (excluding China). Novelos’ second compound, NOV-205, which has been administered to approximately 200 hepatitis patients in clinical trials, is in Phase 2 development for chronic hepatitis C non-responders. Both compounds have been partnered with Lee’s Pharm in China. For additional information about Novelos please visit www.novelos.com