Healthcare Industry News: Novelos Therapeutics
News Release - May 30, 2006
Novelos Therapeutics Finalizes SPA with FDA for Phase 3 Trial in Lung Cancer
Company Expects to Begin Patient Enrollment in 3Q 2006NEWTON, Mass.--(HSMN NewsFeed)--May 30, 2006--Novelos Therapeutics, Inc. (OTCBB: NVLT ), a biotechnology company focused on the development of therapeutics to treat cancer and hepatitis, today announced that it has finalized a Special Protocol Assessment (SPA) with the Food and Drug Administration (FDA) for a single pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) for its lead product NOV-002 in combination with first-line chemotherapy.
This randomized, open-label, international Phase 3 trial will evaluate NOV-002 in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone, in 840 patients with Stage IIIb/IV NSCLC. The trial, with a primary efficacy endpoint of improvement in overall survival, will be conducted across approximately 10 countries and 100 clinical sites. Novelos is planning for patient enrollment to begin in the third quarter of 2006.
During the SPA process, the FDA evaluates the adequacy of the proposed trial's design (including its size, methodology and analysis) to support the efficacy claims that will be part of the New Drug Application (NDA). Under FDA procedures, after a SPA is established, NDA approval will be based on meeting the primary efficacy endpoint, assuming the trial is properly conducted.
"What is agreed to during the SPA process is binding on the FDA's review division and Novelos. As such, it removes much of the uncertainty as to whether our pivotal Phase 3 trial design for advanced NSCLC will be adequate and sufficient to support NOV-002 approval," said Taylor Burtis, Vice President of Regulatory, Quality and Compliance of Novelos.
About Novelos Therapeutics, Inc.
Novelos Therapeutics, Inc. 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 under a SPA, 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 anti-inflammatory properties. 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. For additional information about Novelos please visit www.novelos.com
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: Novelos Therapeutics
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