Novelos abandons candidate in lung cancer
pharmafile | March 20, 2010 | News story | Research and Development | NSCLC, breast cancer
Novelos Therapeutics is to abandon its phase III trials of its drug NOV-002, in combination with first-line chemotherapy.
Trial data shows that 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.
The open-label trial 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.
Novelos says it will now discontinue its NSCLC trials based on these results.
“We designed and executed a robust phase III 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 chief executive of Novelos. “Moving forward, our phase II programmes continue in cancer and hepatitis with our oxidised glutathione-based compounds.
The company expects results from an ongoing NOV-002 phase II breast cancer trial in 3Q 2010, and are scheduled to present new NOV-002 non-clinical data at the American Association for Cancer Research (AACR) Annual Meeting in April 2010. It also expects to begin a phase II hepatitis C trial shortly with its second compound, NOV-205. It also aims rebuild its pipeline through licensing or acquiring clinical-stage oncology compounds.
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