Novelos files IND for novel hepatitis C drug, NOV-205

By Lisa Kerner

Erie, Pa., March 22 - Novelos Therapeutics, Inc. filed an Investigational New Drug application with the Food and Drug Administration for NOV-205, its second clinical stage compound, for hepatitis C.

An initial trial will evaluate NOV-205 as monotherapy for chronic hepatitis C patients who have failed pegylated interferon plus ribavirin therapy, according to a company news release.

NOV-205 is designed to act as a hepatoprotective agent with immunomodulating and antiviral activity.

Previous clinical studies demonstrated that NOV-205 greatly reduced or eliminated hepatitis viral levels and significantly improved abnormal liver enzyme values in patients with hepatitis B and hepatitis C.

The U.S.-based phase 1b trial aims to expand the safety database for NOV-205 and assess its effects on the same key efficacy-related endpoints that showed improvement in the previous studies, the company said.

"This is another significant and fundamental milestone for us," president and chief executive officer Harry Palmin said in the release.

"In addition to being a phase 3 cancer company with NOV-002, Novelos has now commenced a U.S. clinical development program with NOV-205 in chronic hepatitis C - an indication with a large patient population and a major unmet medical need. We plan to initiate this phase 1b trial by mid-2006."

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. The global market for hepatitis C drugs is projected to grow to $10 billion by 2012.

Novelos said the combination of pegylated interferon and ribavirin, the current standard-of-care drugs for chronic hepatitis C, are expensive, have significant toxicities and are difficult for many patients to tolerate.

Located in Newton, Mass., Novelos is a biotechnology company commercializing oxidized glutathione-based compounds for the treatment of cancer and hepatitis.

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