Novelos Therapeutics, Inc. a biotechnology company focused on the development of therapeutics to treat cancer and hepatitis, 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 centre.
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 enrolment to be completed in the first quarter of 2008.
"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 per cent 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 per cent at one year after diagnosis and 5 per cent 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."
NOV-002 is a small molecule drug based on oxidized glutathione that acts as a chemoprotectant and immunomodulator. In a controlled randomized US phase 1/2 clinical trial, advanced NSCLC patients treated with NOV-002 in combination with paclitaxel and carboplatin demonstrated improved objective tumour 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 per cent to 63 per cent NOV-002 has an extensive safety database.