During an “end-of-phase II meeting”, the FDA agreed that a single well-controlled study would be sufficient to support licensure of NOV-002 for the first-line treatment of chemotherapy-naïve, advanced stage, non-small cell lung cancer patients.
Novelos will seek to finalize the pivotal phase III study design under a special protocol assessment during the first half of 2006. The primary endpoint of the pivotal study will be overall survival. The company anticipates enrollment to begin in the third quarter of 2006.
“This is a very significant milestone for us,” said Harry Palmin, president and CEO of Novelos. “Novelos is now a phase III drug development company, with other programs reaching phase II in 2006, including NOV-002 for chemotherapy-resistant ovarian cancer and our second compound, NOV-205, targeting chronic hepatitis C.”