Novelos files SPA with the FDA for phase 3 development in lung cancer

By Elaine Rigoli

Tampa, Fla., March 8 - Novelos Therapeutics, Inc. announced Wednesday that it has filed a Special Protocol Assessment with the Food and Drug Administration for a phase 3 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, according to a company news release.

Novelos expects to finish the phase 3 trial design under an SPA by the end of the second quarter of 2006 and anticipates patient enrollment to begin in the third quarter of 2006, the release said.

During the SPA process, the FDA evaluates issues related to the adequacy of the design of the proposed trial (including its size, method of conduct and analysis) to support the efficacy claims that will be part of the New Drug Application.

If granted, the SPA is then essentially a written contract between the FDA and Novelos regarding the adequacy of the trial design to support an NDA approval, the release said.

"The SPA is binding on the FDA's reviewing division and Novelos. As such, it removes much of the uncertainty as to whether our pivotal phase 3 trial will be adequate and sufficient to support drug approval," said Taylor Burtis, vice president of regulatory, quality and compliance, in a company statement.

Novelos, based in Newton, Mass., is a biotechnology company commercializing oxidized glutathione-based compounds for the treatment of cancer and hepatitis.

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