FDAnews
www.fdanews.com/articles/87163-novelos-completes-spa-for-nov-002-trial

NOVELOS COMPLETES SPA FOR NOV-002 TRIAL

May 30, 2006

Novelos Therapeutics has finalized a special protocol assessment 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 company stated that the trial will be conducted in about 10 countries and 100 clinical sites. The company is planning for patient enrollment to begin in the third quarter of 2006.