Novelos ends safety trial of hep C drug on good news

Mass High Tech: The Journal of New England Technology

Thursday, December 13, 2007
www.bizjournals.com

Novelos Therapeutics Inc. reports concluding its initial U.S.-based Phase 1b trial for a hepatitis C therapy with good safety results.

The Newton-based biopharmaceutical company was evaluating NOV-205 as a therapy in chronic hepatitis C genotype 1 patients who had previously failed treatment with interferon plus ribavirin.

Based on favorable safety data in the 14-dose trial with 18 subjects, Novelos said it plans to initiate a longer proof-of-concept trial in hepatitis C nonresponders during the second half of 2008.

NOV-205 has been approved in the Russian Federation, based on a longer duration of dosing in treating hepatitis B and C patients who have not yet received other treatments. NOV-205 was also tolerated well in those studies, officials said.

According to the World Health Organization, chronic hepatitis C affects 170 million people worldwide and up to 4 million people are newly infected each year. Chronic infection can progress to cirrhosis, end-stage liver disease and hepatocellular carcinoma.