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Novelos gets FDA OK for lung cancer trial


dadstimeon

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http://www.masshightech.com/displayarti ... t_ID=70457

12/05/2005 10:27 AM

Novelos Therapeutics Inc., a Newton company focused on the development of therapeutics to treat cancer and hepatitis, has received approval from the Food and Drug Administration for trials of the company’s NOV-002 into a single pivotal Phase 3 study in advanced non-small cell lung cancer, in combination with first-line chemotherapy.

Novelos will seek to finalize the 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 was established in 1996 to commercialize two oxidized glutathione-based compounds, NOV-002 and NOV-205, for the treatment of cancer and hepatitis.

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