Below is the text of a Novelos press release describing NOV-205 and the new study. Further trial details and enrollment information is available on the ClinicalTrials.gov web site.
Novelos Therapeutics Enrolls First Patient in Phase 2
Hepatitis C Trial with NOV-205
Trial Conclusion Expected in 2011; Preliminary Results Expected 3Q 2010
Newton, Mass. -- March 25, 2010 -- Novelos Therapeutics, Inc., 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 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.
4/2/10
Source
Novelos Therapeutics. Novelos Therapeutics Enrolls 1st Patient in Phase 2 Hepatitis C Trial with NOV-205. Press release. March 25, 2010.
