SOURCE: Novelos Therapeutics, Inc.

August 03, 2005 08:00 ET

Novelos Therapeutics Names New Vice President of Regulatory, Quality and Compliance

Ms. Taylor Burtis, Former FDA Reviewer and Senior Executive at Wyeth and Genentech, to Head Novelos' Regulatory Affairs

NEWTON, MA -- (MARKET WIRE) -- August 3, 2005 -- Novelos Therapeutics, Inc. (OTC BB: NVLT), a biotech company focusing on oxidized glutathione for use in fighting cancer and hepatitis, announced today that Ms. Taylor Burtis has been named Vice President of Regulatory, Quality and Compliance for the Company.

Ms. Burtis has over 25 years of regulatory and senior management experience. Over the past several years, she has developed and implemented regulatory strategy at two cancer biotechnology companies, resulting in filings for multiple Phase 3 trials. Ms. Burtis was an Associate Director for World Wide Regulatory Affairs at Wyeth for three years and a Senior Manager of Regulatory Affairs at Genentech for four years. Notably, Ms. Burtis was an FDA Consumer Safety Officer in the Office of Compliance at the Center for Biologics Evaluation and Research from 1992-1996. Previously, she spent 12 years as a regulatory, project and operations manager at various medical institutions, including Children's Hospital, Brigham & Women's and the American Red Cross.

"We are extremely pleased to have Taylor Burtis join our senior management team," said Harry S. Palmin, President and Acting CEO of Novelos Therapeutics. "Her 25 years of regulatory expertise as an FDA reviewer and at both big pharma and biotech companies will be invaluable to Novelos. We very much look forward to Ms. Burtis developing and implementing our cancer and hepatitis regulatory strategies."

About Novelos Therapeutics, Inc.

Novelos Therapeutics, Inc. (OTC BB: 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®, has been administered to over 5,000 patients, demonstrating clinical efficacy and excellent safety data. The U.S.-based Phase 1/2 clinical trial of NOV-002 for lung cancer has been completed. 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. Phase 1/2 clinical study has been completed.

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.

Consulting For Strategic Growth I, Ltd. ("CFSG") has a June 1, 2005, contract to provide Novelos with consulting, business advisory, investor relations, public relations and corporate development services for a three-month period. In connection with these services, CFSG prepares press releases, corporate profiles, and other publications on behalf of the Company. Independent of CFSG's receipt of cash compensation from the Company, CFSG may choose to purchase the common stock of the Company and thereafter liquidate those securities at any time it deems appropriate to do so.

Contact Information

    Harry S. Palmin, President and Acting CEO
    Novelos Therapeutics, Inc.
    One Gateway Center, Ste. 504
    Newton, MA 02458
    Ph: 617-244-1616 ext.11
    Fax: 631-574-3130
    Email: Email Contact

    Stanley Wunderlich. CEO
    Consulting for Strategic Growth
    800 Second Avenue
    New York, NY 10017
    Ph: 800-625-2236
    Fax: 212-337-8089
    Email: Email Contact