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Novelos Therapeutics Enrolls 1st Patient in Pivotal Phase 3 Lung Cancer Trial

Posted on: Monday, 6 November 2006, 21:00 CST

Novelos Therapeutics, Inc. (OTCBB: NVLT), a biotechnology company focused on the development of therapeutics to treat cancer and hepatitis, today announced that the first patient has been enrolled 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. from Massachusetts General Hospital (MGH) are the trial co-Chairs. Dr. Lynch is Director of MGH's Center for Thoracic Cancers and Dr. Fidias is Clinical Director for the Center.

This randomized, open-label, international Phase 3 trial is being conducted under a Special Protocol Assessment (SPA) and will study 840 patients with Stage IIIb/IV NSCLC. It will evaluate 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, will be conducted across approximately 100 clinical sites in 10 countries. Novelos is planning for patient enrollment to be completed in the first quarter of 2008. A link to the trial description and contact information is available at www.novelos.com on the 'Clinical Trials' page.

"I am very pleased to be collaborating with MGH and other excellent institutions world-wide, and having Drs. Lynch and Fidias, who are recognized experts in treating lung cancer, as Co-Chairs for our pivotal Phase 3 lung cancer trial," said Harry Palmin, President and CEO of Novelos.

Lung cancer is the leading cause of cancer death in the U.S. According to the American Cancer Society, it is expected that in 2006 approximately 175,000 Americans will be diagnosed with lung cancer and more than 160,000 will die 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 and 5% after five years) 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 be 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 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 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, and is in addition being developed for acute radiation injury. 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: Business Wire

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