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(1) www.novelos.com/ NOV-002, the lead compound acts as a chemopotentiator and a chemoprotectant, in combination with chemotherapy. Novelos is conducting an international pivotal Phase 3 trial of NOV-002 for treatment of lung cancer, under a Special Protocol Assessment (SPA) and Fast Track. Trial conclusion is expected in early 2010. NOV-002 is approved and marketed in Russia by Pharma BAM under the trade name Glutoxim®. It has been administered to over 10,000 patients, including clinical studies of 390 patients across many tumor types, demonstrating clinical efficacy and excellent safety data.
Novelos' randomized, open-label, international, pivotal Phase 3 trial is evaluating NOV-002 in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone, in approximately 900 patients with Stage IIIb/IV NSCLC. The trial, with a primary efficacy endpoint of improvement in median overall survival, is being conducted across approximately 12 countries and 100 clinical sites. Novelos commenced the trial in November 2006, and reached target enrollment of 840 patients in March 2008. This pivotal Phase 3 trial is expected to conclude in early 2010. (2) www.novelos.com/docs/Novelos%20PR%201-7-10%20Ph3%20725.pdf January 7, 2010
NOVELOS THERAPEUTICS REACHES 725th EVENT IN PIVOTAL PHASE 3 LUNG CANCER TRIAL ...According to the SAP, a total of 725 events are required to detect a 25% improvement in overall survival (hazard ratio of 0.8) with 85% power and a two-sided significance level of 0.05. (3) www.novelos.com/ NOV-002 was approved in Russia where it is marketed by PharmaBAM under the trade name Glutoxim®. NOV-002 has already been administered to over 10,000 patients, including clinical studies of 390 patients across many tumor types, demonstrating clinical efficacy and excellent safety. In one controlled, randomized Russian Phase 2 trial, NOV-002 in combination with cisplatin-based chemotherapy increased the one-year survival of advanced NSCLC patients from 17% to 63% (p < 0.01) and improved tolerance of chemotherapy (p < 0.01) versus the control. (4) finance.yahoo.com/news/Novelos-NVLTOB-Study-Patients-iw-313571586.html Novelos' (NVLT.OB) Study Patients Continue to Live Longer as Pfizer Stops Lung Cancer Study ...it was reported that an independent data monitoring committee found by analyzing data from Pfizer's late-stage study that the addition of figitumumab to a combination of older medications -- paclitaxel and carboplatin -- was unlikely to meet the primary endpoint of improving overall survival compared to the combination of paclitaxel and carboplatin alone. Meanwhile, Novelos' randomized, open-label, international, pivotal Phase 3 trial continues evaluating NOV-002 in combination with paclitaxel and carboplatin versus paclitaxel and carboplatin alone, in approximately 900 patients with Stage IIIb/IV lung cancer. Other drugs like motesanib, by Takeda Pharmaceutical and Amgen and Nexavar, from Bayer and Onyx Pharmaceuticals, have shown negative effects in that cell type, leaving the market wide open for Novelos' NOV-002. "We actually potentiate the chemotherapy," said Palmin in a recent interview with BioMedReports. "We make the cancer cells more sensitive to chemotherapy and we also inhibit the cancer's ability to metastasize (spread), so there are all sorts of interesting effects that happen at the tumor level. However, on the normal cells -- for example bone marrow cells and blood cells -- which of course get damaged by chemotherapy -- we don't stop the damage but we do help the recovery from that damage. In the words of big pharma, 'if this Phase III trial is positive, this will be revolutionary for the cancer field.'"
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