Novelos Therapeutics reported that a Phase III trial with its non-small-lung cancer (NSCLC) drug did not meet its primary endpoint of overall survival. NOV-002 was being assessed in combination with first-line chemotherapy in a randomized, controlled, open-label study in 903 patients with Stage 3b/4 NSCLC.
Enrollment commenced in November 2006, and target enrollment was achieved in March 2008. The trial, conducted across approximately 100 clinical sites in 12 countries, evaluated NOV-002 in combination with first-line paclitaxel and carboplatin chemotherapy versus paclitaxel and carboplatin alone. A total of 725 events were required to detect a 25% improvement of 12.5 months versus 10 months in overall median survival.
“We were hopeful of a positive outcome based on our statistical model simulations and stated assumptions,” remarks Harry Palmin, president and CEO of Novelos. “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 III lung cancer trial results later this year. Meanwhile, we are scheduled to present new NOV-002 preclinical data at the AACR meeting in April, and we are on track for results from a NOV-002 Phase II breast cancer trial in the third quarter of 2010. We are also on track to initiate a Phase II hepatitis C trial shortly with our second compound NOV-205.”
NOV-002 is a small molecule based on a formulation of oxidized glutathione that acts together with chemotherapy as a chemopotentiator and a chemoprotectant by regulating redox-sensitive cell-signaling pathways. Besides breast cancer, NOV-002 is also in Phase II development for chemotherapy-resistant ovarian cancer. Novelos has a partnership with Mundipharma to develop and commercialize NOV-002 in Europe and Asia excluding China.
The company’s second compound, NOV-205, acts as a hepatoprotective agent with immunomodulating and anti-inflammatory properties. NOV-205 is in Phase Ib development for chronic hepatitis C nonresponders. Both NOV-205 and NOV-002 compounds have been partnered with Lee’s Pharm in China.