Healthcare Industry News: NOV-002
News Release - March 13, 2008
Novelos Therapeutics Reaches Target Enrollment in Pivotal Phase 3 Lung Cancer TrialTrial Conclusion is Expected mid-2009
NEWTON, Mass.--(HSMN NewsFeed)--Novelos Therapeutics, Inc. (OTCBB: NVLT ), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that Novelos has reached the target enrollment of 840 patients in the pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) for its lead product NOV-002 in combination with first-line chemotherapy. Thomas Lynch, M.D. and Panos Fidias, M.D., recognized experts in treating lung cancer from the Massachusetts General Hospital Cancer Center, are the trial co-Chairs. Dr. Lynch is Director of the Center for Thoracic Cancers and Dr. Fidias is Clinical Director for the Cancer Center.
This randomized, open-label, international Phase 3 trial, being conducted under a Special Protocol Assessment (SPA), has enrolled 840 patients with Stage IIIb/IV NSCLC since enrollment started in November 2006. The trial is evaluating NOV-002 in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone. The trial, with a primary efficacy endpoint of improvement in median overall survival, is being conducted across approximately 100 clinical sites in 12 countries. The independent Data Monitoring Committee (DMC), which reviews the safety data from the trial, has recommended continuation of the trial as planned at each of its quarterly data review meetings. The trial will conclude upon reaching 725 events, which Novelos expects in mid-2009.
“I am very pleased that we have reached our pivotal Phase 3 enrollment target on schedule,” said Harry Palmin, President and CEO of Novelos. “I would like to thank the Massachusetts General Hospital Cancer Center and other excellent institutions world-wide for their diligent patient enrollment and participation in our trial. We expect top-line median overall survival data in mid-2009.”
Lung cancer is the leading cause of cancer death in the U.S. According to the American Cancer Society, it is estimated that in 2007 approximately 213,000 Americans will have been diagnosed with lung cancer and 160,000 will have died as a result. NSCLC accounts for more than 80% of lung cancer. Platinum-based chemotherapy regimens, such as paclitaxel and carboplatin, are standard first-line treatment for advanced NSCLC patients since these patients are not eligible for surgery. However, the efficacy of currently available treatments is marginal (survival rates of only about 35% at one year after diagnosis, 5% after five years, median overall survival of 8-10 months) and they are characterized by a high rate of severe toxicities.
“Advanced lung cancer patients are in need of new, safer and more effective therapies,” said Dr. Fidias. “Based on overseas and U.S. clinical data, NOV-002 added to the chemotherapy holds promise in the therapy of lung cancer and we are excited to have been able to offer this trial to our patients.”
About NOV-002 for NSCLC
NOV-002 is a small molecule drug based on oxidized glutathione that acts as a chemoprotectant and immunomodulator. In a controlled randomized U.S. Phase 1/2 clinical trial, advanced NSCLC patients treated with NOV-002 in combination with paclitaxel and carboplatin demonstrated improved objective tumor response and higher tolerance of chemotherapy versus the control group. In a controlled randomized Russian trial, when used in combination with cisplatin-based chemotherapy, NOV-002 increased the one-year survival of advanced NSCLC patients from 17% to 63%. NOV-002 has an extensive safety database.
About Massachusetts General Hospital Cancer Center
As the largest provider of care to cancer patients in New England and a leading center in the United States, the Massachusetts General Hospital Cancer Center stands at the forefront in the fight against cancer. Additional information is available at www.massgeneral.org/cancer
About Novelos Therapeutics, Inc.
Novelos Therapeutics, Inc. is a biopharmaceutical 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 and Fast Track, acts together with chemotherapy as a chemoprotectant and an immunomodulator. NOV-002 is also in Phase 2 development for chemotherapy-resistant ovarian cancer and early-stage breast cancer. NOV-205 acts as a hepatoprotective agent with immunomodulating and anti-inflammatory properties. NOV-205 is in Phase 1b development for chronic hepatitis C non-responders. 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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