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Novelos Therapeutics to Meet FDA in Early December to Review Positive Phase 1/2 Lung Cancer Data and Present Its Proposed Pivotal Phase 3 Study Design

Posted on: Monday, 24 October 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 FDA has granted the Company an End-of-Phase 2 meeting, scheduled for December 2, 2005.

On October 14, 2005, Novelos Therapeutics submitted a request for a Type B end of Phase 2/pre-Phase 3 meeting for its lead development product, NOV-002, with the FDA, Center for Drug Evaluation and Research, Division of Oncology Drug Products. One objective of the December 2nd meeting will be to review the positive Phase 1/2 tumor response data in non-small cell lung cancer (NSCLC) patients treated with NOV-002 in combination with chemotherapy. In addition, the Company will present its proposed design for the pivotal Phase 3 study of NOV-002 in combination with chemotherapy for NSCLC. Novelos is asking to conduct the Phase 3 study under a Special Protocol Assessment (SPA). The Company and the FDA intend to design the SPA to allow the study to support approval of NOV-002 in combination with chemotherapy for the treatment of NSCLC patients.

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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