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Novelos Therapeutics Phase 3 trial of NOV-002 in advanced NSCLC fails to meet primary and secondary endpoints

Published on March 18, 2010 at 9:33 AM · No Comments

Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that primary and secondary endpoints were not met in Novelos’ pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) with its lead product, NOV-002, in combination with first-line chemotherapy. Adding NOV-002 to paclitaxel and carboplatin chemotherapy was not statistically or meaningfully different in terms of efficacy-related endpoints or recovery from chemotherapy toxicity versus chemotherapy alone. NOV-002 was safe, as it did not add to the overall toxicity of chemotherapy. Detailed trial results are expected to be presented at the 2010 annual meeting of the American Society of Clinical Oncology (ASCO) taking place June 4-8 in Chicago, Illinois.

“We designed and executed a robust Phase 3 NSCLC trial, but disappointingly, NOV-002 did not work in this very difficult to treat indication in combination with this chemotherapy

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