Novelos: FDA says single phase 3 trial sufficient to license NOV-002 to treat lung cancer

By E. Janene Geiss

Philadelphia, Dec. 5 - Novelos Therapeutics, Inc. said the Food and Drug Administration agreed that advancing NOV-002 into a single pivotal phase 3 study in advanced non-small cell lung cancer, in combination with first-line chemotherapy, is warranted at this time.

The FDA also provided helpful feedback regarding the prospective New Drug Application filing for NOV-002, company officials said in a Monday news release.

During the "End-of-Phase 2" meeting, the FDA agreed that a single, well-controlled study would be sufficient to support licensure of NOV-002 (in combination with chemotherapy) for the first-line treatment of chemotherapy-naive stage IIIb/IV non-small cell lung cancer patients, officials said.

Novelos said it will seek to finalize the pivotal phase 3 study design under a Special Protocol Assessment during the first half of 2006.

The primary endpoint of the pivotal study will be overall survival. Novelos anticipates enrollment to begin in the third quarter of 2006, officials said.

"Novelos is now a phase 3 drug-development company, with other programs reaching phase 2 in 2006, including NOV-002 for chemotherapy-resistant ovarian cancer and our second compound, NOV-205, targeting chronic hepatitis C," said Harry Palmin, president and chief executive officer, in the release.

Newton, Mass.-based Novelos is a biotechnology company focused on the development of therapeutics to treat cancer and hepatitis.

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