NOVELOS FILES SPA FOR PHASE 3 DEVELOPMENT IN LUNG CANCER

Novelos Therapeutics has filed a special protocol assessment (SPA) with the FDA for a single pivotal Phase III trial in advanced non-small cell lung cancer, for its lead product NOV-002 in combination with first-line chemotherapy. The primary endpoint of the trial is overall survival.

Novelos expects to finalize the trial design under the SPA by the end of the second quarter of 2006 and anticipates patient enrollment to begin in the third quarter of 2006.