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

Mar 18 2010

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”

This randomized, controlled, open-label Phase 3 trial, conducted under a Special Protocol Assessment (SPA) and Fast Track designation, enrolled 903 patients with Stage IIIb/IV NSCLC and included all histological subtypes. The trial encompassed approximately 100 clinical sites in 12 countries and evaluated NOV-002 in combination with first-line paclitaxel and carboplatin chemotherapy versus paclitaxel and carboplatin alone. The primary efficacy endpoint of the trial was improvement in overall survival. Secondary endpoints included progression free survival, response rate and duration of response, recovery from chemotherapy-induced myelosuppression, determination of immunomodulation, quality of life and safety. Based on results from this Phase 3 trial, Novelos will discontinue development of NOV-002 for NSCLC in combination with first-line paclitaxel and carboplatin chemotherapy.

“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,” said Harry Palmin, President and CEO of Novelos. “Moving forward, our Phase 2 programs continue in cancer and hepatitis with our oxidized glutathione-based compounds. We expect results from an ongoing NOV-002 Phase 2 breast cancer trial in 3Q 2010, and are scheduled to present new NOV-002 nonclinical data at the American Association for Cancer Research (AACR) Annual Meeting in April 2010. We also expect to initiate a Phase 2 hepatitis C trial shortly with our second compound NOV-205. Meanwhile, we intend to rebuild our pipeline through licensing or acquiring clinical-stage oncology compounds, utilizing our experienced and proven development team.”