Unfortunately Novelos Therapeutics, Inc. made the announcement that the initial endpoint of progress in overall survival was not met in Novelos’ pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) studying its lead product, NOV-002, in combination with first-line chemotherapy.
“We are very disappointed that our pivotal Phase 3 lung cancer trial did not meet the primary survival endpoint,” said Harry Palmin, President and CEO of Novelos. “We were hopeful of a positive outcome based on our statistical model simulations and stated assumptions. In retrospect, it appears our simulations were inaccurate due to trial data deviating from our statistical model, the impact of censoring patterns, and control arm survival exceeding our expectations based on historical precedents. We will conduct a thorough analysis of all the data, and expect to present detailed Phase 3 lung cancer trial results later this year. Meanwhile, we are scheduled to present new NOV-002 preclinical data at the AACR Annual Meeting in April 2010, and we are on track for results from a NOV-002 Phase 2 breast cancer trial in 3Q 2010. We are also on track to initiate a Phase 2 hepatitis C trial shortly, with our second compound NOV-205.”
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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 that completed a Phase 3 trial for lung cancer, acts together with chemotherapy as a chemopotentiator and a chemoprotectant. NOV-002 is also in Phase 2 development for early-stage breast cancer and chemotherapy-resistant ovarian cancer. Novelos has a partnership with Mundipharma, an independent associated company of Purdue Pharma, to develop and commercialize NOV-002 in Europe and Asia (excluding China). Novelos’ second compound, 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 been partnered with Lee’s Pharm in China.
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