• E-mail
• Print
• Comment
• Font Size
• Digg
• del.icio.us
• Discuss article

Novelos Therapeutics to Present Positive Results From Phase 1/2 Lung Cancer Study at International Cancer Conference in Boston

Posted on: Friday, 16 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 that the Company's positive results from a Phase 1/2 non-small cell lung cancer study with its lead product, NOV-002, have been accepted for presentation at the 2nd International Conference on Tumor Progression & Therapeutic Resistance. The conference will be held on September 18-20 at the Boston Marriott Hotel in Burlington, Mass. and will focus on identifying new opportunities for therapeutic development derived from a better understanding of the complex molecular and cellular changes associated with malignant tumor progression. Sessions will include presentations on new drugs and combinations in pre-clinical or clinical testing, including NOV-002.

Christopher J. Pazoles, Ph.D., Vice President of Research and Development of Novelos Therapeutics, will conduct the poster presentation entitled "A Randomized Phase 1/2, Open-Label, Controlled Study of NOV-002 in Non-Small Cell Lung Cancer." Dr. Hal Gerstein of Cancer Research of Long Island, Inc., the principal investigator in the Phase 1/2 study, co-authored the presentation. It will summarize key findings including the significantly greater anti-tumor effect seen in patients treated with NOV-002 in combination with standard chemotherapy compared to those receiving chemotherapy alone. The presentation will also describe results showing that NOV-002 was well-tolerated, thus extending the compound's already extensive safety database.

The Novelos poster is available for viewing at www.novelos.com

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

More News in this Category