Jan 8 2010
Novelos Therapeutics, Inc. (OTCBB: NVLT), a biopharmaceutical company focused on the development of therapeutics to treat cancer and hepatitis, today announced that the 725th event (patient death) has been reached in its pivotal Phase 3 trial in advanced non-small cell lung cancer (NSCLC) studying its lead product, NOV-002, in combination with first-line chemotherapy. The 725th event triggers the steps towards the pre-specified analysis according to the trial’s Statistical Analysis Plan (SAP). Top-line trial results are expected to be available later in the first quarter.
“We are on track for our pivotal Phase 3 trial to conclude this quarter”
This randomized, controlled, open-label Phase 3 trial, being conducted under a Special Protocol Assessment (SPA) and Fast Track designation, has enrolled 903 patients with Stage IIIb/IV NSCLC, which includes all histological subtypes. The trial, conducted across approximately 100 clinical sites in 12 countries, is evaluating NOV-002 in combination with first-line paclitaxel and carboplatin chemotherapy versus paclitaxel and carboplatin alone. The primary efficacy endpoint of the trial is improvement in overall survival. Enrollment commenced in November 2006 and the target enrollment was achieved in March 2008. 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. No interim analysis was performed.
“We are on track for our pivotal Phase 3 trial to conclude this quarter,” said Harry Palmin, President and CEO of Novelos. “Should this registrational trial be positive, we will proceed with filing a New Drug Application (NDA) in 3Q 2010. Thereafter, based on our Fast Track designation, we would project FDA approval for first-line treatment of advanced NSCLC in combination with chemotherapy in 1Q 2011.”
Source: Novelos Therapeutics, Inc.
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