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Treatment for Chronic Hepatitis C

Novelos Therapeutics Files IND for Novel Hepatitis C Drug; IND Represents Company's Second Clinical Stage Compound

NEWTON, Mass., March 22, 2006 - Novelos Therapeutics, Inc., a biotechnology company focused on the development of therapeutics to treat cancer and hepatitis, today announced that it has filed an Investigational New Drug Application (IND) with the Food and Drug Administration (FDA) for NOV-205, its second clinical stage compound. The initial U.S.-based trial will evaluate NOV-205 as monotherapy for chronic hepatitis C patients who have failed pegylated interferon plus ribavirin therapy.

NOV-205 is designed to act as a hepatoprotective agent with immunomodulating and antiviral activity. Its regulatory approval in the Russian Federation was based on clinical studies in hepatitis B and C patients in which NOV-205 greatly reduced or eliminated hepatitis viral levels and significantly improved abnormal liver enzyme values. NOV-205 was well-tolerated in these studies, and its manufacturing is simple and low cost. 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 Russian studies.

"This is another significant and fundamental milestone for us," said Harry Palmin, President and CEO of Novelos. "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."

The World Health Organization estimates that chronic hepatitis C affects 170 million people worldwide and up to four million people are newly infected each year. Chronic infection can progress to cirrhosis, end-stage liver disease and hepatocellular carcinoma. While estimates of the size of the global market for hepatitis C drugs vary, it is currently believed to be in excess of $2 billion per year, and projected to grow to $10 billion by 2012. In the U.S., according to the Centers for Disease Control and Prevention, an estimated 3.9 million persons are infected with hepatitis C, and 2.7 million persons in the U.S. are chronically infected. Hepatitis C accounts for approximately 30,000 new infections and 8,000-10,000 deaths each year in the U.S.

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 are non-responders to pegylated interferon plus ribavirin therapy, and currently there is no approved standard of care to treat these chronic HCV patients.

Source: Novelos Therapeutics, Inc.

Posted: March 2006

NOV-205 FDA Approval History