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Novelos Therapeutics Announces Collaboration With Medical University of South Carolina

Posted on: Tuesday, 13 September 2005, 09:00 CDT

Novelos Therapeutics, Inc. (OTCBB: NVLT), a biotechnology company focusing on oxidized glutathione for use in fighting cancer and hepatitis, announced today a research collaboration with the Medical University of South Carolina (MUSC). Further, Novelos Therapeutics and MUSC will make a joint presentation on recent NOV-002 mechanism of action studies at the upcoming International Conference on Molecular Targets and Cancer Therapeutics sponsored by the American Association for Cancer Research, the National Cancer Institute and the European Organization for Research and Treatment of Cancer.

The overall objective of the Novelos/MUSC research program is to add to the understanding of how NOV-002 and NOV-205 (Novelos' development stage products) act at a cellular and molecular level to provide the clinical benefits they have demonstrated in cancer and hepatitis C patients, respectively. This information will aid design and execution of clinical studies, facilitate interactions with the FDA and other global Regulatory Authorities, and provide a basis for further growth of its product portfolio. Kenneth D. Tew, Ph.D., D.Sc., the program's principal investigator, is Chairman of the Department of Cell and Molecular Pharmacology and Experimental Therapeutics at MUSC and is a world renowned expert on the glutathione pathway and its relation to cancer therapy. He also serves as Chairman of Novelos Therapeutics' Scientific Advisory Board.

The Novelos/MUSC presentation at the International Conference on Molecular Targets and Cancer Therapeutics (to be held in Philadelphia, PA on November 14-18, 2005), describes the ability of NOV-002 to reversibly modify proteins in human cells, some of which are known to play critical regulatory roles in governing cell proliferation and apoptosis (programmed cell death). Such signal pathway modulation may contribute to the clinical efficacy demonstrated by NOV-002 in US and non-US clinical studies in combination with cytotoxic chemotherapies.

"We are very pleased to be collaborating with MUSC, a leading medical research institution, to better understand the cellular and molecular actions of NOV-002 and, in particular, how it interacts with the glutathione pathway", said Christopher J. Pazoles, Ph.D., Vice President of Research & Development at Novelos Therapeutics. "We are encouraged by the results of these initial mechanistic studies, and look forward to continued fruitful collaboration with Dr. Tew and his staff."

About Novelos Therapeutics, Inc.

Novelos Therapeutics, Inc. (OTCBB: NVLT) was established in 1996 to commercialize two promising oxidized glutathione-based compounds, NOV-002 and NOV-205, for the treatment of cancer and hepatitis. Both compounds have completed clinical trials in humans and have been approved for use in the Russian Federation where they were developed. NOV-002, marketed in Russia by an unrelated entity under the trade name GLUTOXIM(R), has been administered to over 5,000 patients, demonstrating clinical efficacy and excellent safety data. The U.S.-based Phase 1/2 clinical study of NOV-002 in combination with chemotherapy for lung cancer has been completed, with positive results. A Phase 2B/3 study is expected to commence in 2006. The Company plans to file an IND with the FDA for NOV-205 as a mono-therapy for hepatitis C in 2005.

About the Products

NOV-002, the lead compound, is being developed to treat non-small cell lung cancer (NSCLC). NOV-002 is designed to act as a cytoprotectant and an immunomodulator. When used in combination with chemotherapy, NOV-002 increased the one-year survival rate from 17% to 63% in a Russian study, a result that also represents an 80% improvement above the U.S. 35% current standard of care. A U.S.-based Phase 1/2 clinical study has been completed. NOV-002 treated patients demonstrated improved objective tumor response (defined as greater than 50% tumor shrinkage) and higher tolerance of chemotherapy versus the control group. NOV-002 was well tolerated, thus adding to the compound's already extensive safety data base.

NOV-002 is also being developed to treat refractory (that is, not responsive to chemotherapy) ovarian cancer. Two additional clinical indications, radiation protection and psoriasis, will also be investigated for NOV-002.

NOV-205 is being developed to treat chronic hepatitis C in the U.S. NOV-205 is designed to act as a hepatoprotective agent with immunomodulating and antiviral activity. In Russian clinical studies, when used as mono-therapy for one month in hepatitis B and for two months in hepatitis C, NOV-205 has been shown to greatly reduce or eliminate viral loads and to vastly improve liver function relative to existing drugs on the market.

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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