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Novelos Therapeutics Enrolls 1st Patient in Hepatitis C Trial With NOV-205

Posted on: Thursday, 28 September 2006, 09:00 CDT

Novelos Therapeutics, Inc. (OTCBB: NVLT), a biotechnology company focused on the development of therapeutics to treat cancer and hepatitis, today announced that the first patient has been enrolled in a hepatitis C trial with NOV-205, the company's second compound. The initial U.S.-based double-blind, placebo-controlled Phase 1b trial will evaluate NOV-205 versus placebo as monotherapy in 30 chronic hepatitis C genotype 1 patients who previously failed treatment with pegylated interferon plus ribavirin. A link to the trial description and contact information is available at www.novelos.com on the 'Clinical Trials' page.

NOV-205 acts as a hepatoprotective agent with immunomodulating and anti-inflammatory properties. 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 for at least 30 days post treatment and significantly improved or normalized serum biochemical markers of liver damage. NOV-205 was well-tolerated in these studies. The compound's manufacture is simple and low cost. The U.S.-based Phase 1b trial aims to expand the safety and pharmacokinetic 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 Novelos," said Harry Palmin, President and CEO of Novelos. "In addition to being in Phase 3 development with NOV-002 for lung cancer, Novelos has now commenced a U.S. trial with NOV-205 in chronic hepatitis C non-responders -- another indication with a large patient population and a major unmet medical need. We expect results from this robustly designed trial in the first half of 2007."

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 $3 billion per year, and projected to grow in excess of $8 billion by 2010. 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.

About Novelos Therapeutics, Inc.

Novelos Therapeutics, Inc. is a biotechnology company commercializing oxidized glutathione-based compounds for the treatment of cancer and hepatitis. NOV-002, the lead compound currently in Phase 3 development for lung cancer under a SPA and Fast Track, acts together with chemotherapy as a chemoprotectant and an immunomodulator. NOV-002 is also in Phase 2 development for chemotherapy-resistant ovarian cancer and is in addition being developed for acute radiation injury. NOV-205 acts as a hepatoprotective agent with immunomodulating and anti-inflammatory properties. NOV-205 is in Phase 1b development for chronic hepatitis C non-responders. Both compounds have completed clinical trials in humans and have been approved for use in the Russian Federation where they were originally developed. For additional information about Novelos please visit www.novelos.com

This news release contains forward-looking statements. Such statements are valid only as of today, and we disclaim any obligation to update this information. These statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk. Factors that might cause such a material difference include, among others, uncertainties related to the ability to attract and retain partners for our technologies, the identification of lead compounds, the successful preclinical development thereof, the completion of clinical trials, the FDA review process and other government regulation, our pharmaceutical collaborators' ability to successfully develop and commercialize drug candidates, competition from other pharmaceutical companies, product pricing and third-party reimbursement.

Source: Business Wire

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