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Novelos Therapeutics IND for Novel Hepatitis C Drug is Accepted by FDA; Company Is on Track to Begin Patient Enrollment by July 2006
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NEWTON, Mass.--(BUSINESS WIRE)--April 24, 2006 - Novelos Therapeutics, Inc. (OTCBB: NVLT), a biotechnology company focused on the development of therapeutics to treat cancer and hepatitis, today announced that the Food and Drug Administration (FDA) accepted Novelos' Investigational New Drug Application (IND) for NOV-205, its second clinical stage compound. The initial U.S.-based Phase 1b trial will evaluate NOV-205 as monotherapy for chronic hepatitis C genotype 1 patients who have failed pegylated interferon plus ribavirin therapy.
NOV-205 is designed to act as a hepatoprotective agent with immunomodulating and antiinflammatory 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 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 Novelos," 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 July 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.
About Novelos Therapeutics, Inc.
Novelos Therapeutics, Inc. (OTCBB: NVLT) 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, is designed to act as a chemoprotectant and an immunomodulator. NOV-002 is also being developed to treat chemotherapy-resistant ovarian cancer and acute radiation injury. NOV-205, a second compound, is designed to act as a hepatoprotective agent with immunomodulating and antiviral activity. Novelos plans to initiate a U.S.-based NOV-205 clinical trial for chronic hepatitis C by mid-2006. Both compounds have completed clinical trials in humans and have been approved for use in the Russian Federation where they were originally developed.
NOV-002, the lead compound, is designed to act as a chemoprotectant and an immunomodulator. It is marketed in Russia by PharmaBAM under the trade name Glutoxim , and has been administered to over 5,000 patients, demonstrating clinical efficacy and excellent safety. The U.S.-based Phase 1/2 clinical trial of NOV-002 for non-small cell lung cancer (NSCLC) has been completed, with positive results. During an End-of-Phase 2 meeting, the FDA agreed that a single well-controlled trial would be sufficient to support licensure of NOV-002 (in combination with chemotherapy) for the first-line treatment of chemotherapy-naive Stage IIIb/IV NSCLC patients. The pivotal Phase 3 trial is expected to commence in 2006. NOV-002 is also being developed to treat chemotherapy-resistant ovarian cancer and acute radiation injury.
NOV-205, a second compound, is designed to act as a hepatoprotective agent with immunomodulating and antiinflammatory properties. In Russian clinical studies in hepatitis B and C patients, NOV-205 greatly reduced or eliminated viral load and significantly improved liver function. Novelos plans to file an Investigational New Drug Application (IND) with the FDA for NOV-205 as mono-therapy for chronic hepatitis C in the first quarter of 2006 and initiate a U.S.-based clinical trial in the second quarter.
Novelos's current pipeline of drugs is based on oxidized glutathione, a natural metabolite, and has shown excellent safety as well as preclinical and clinical efficacy in numerous cancers, hepatitis B and C, HIV, psoriasis, tuberculosis and certain other diseases. The lead products are believed to act via glutathionylation of critical regulatory molecules that mediate immune function, tumor progression (in combination with chemotherapy), and drug detoxification. Manufacturing of these proprietary small molecules is simple, low cost, and scalable, and both compounds are currently produced cGMP in the U.S. by manufacturing partners.
Novelos' intellectual property is very strong. The intellectual property includes 4 U.S., 2 European and 1 Japanese patents (issued 2000-2004) and 30 patent applications filed worldwide, with coverage including composition of matter, method of use and manufacturing. The breadth of the intellectual property will also allow Novelos to expand its pipeline by claiming and commercializing additional compounds that are based on oxidized glutathione.
Contact Novelos Therapeutics, Inc. Harry S. Palmin, 617-244-1616 x11 President and CEO hpalmin@novelos.com OR H.C. Wainwright & Co, Inc. Stephen Lichaw, 212-856-5706 Vice President slichaw@hcwainwright.com
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