Novelos to meet FDA on Dec. 2 to discuss results, propose phase 3 trial for lung cancer drug

New York, Oct. 24 - Novelos Therapeutics, Inc. said it will meet with the Food and Drug Administration on Dec. 2 to discuss the results of its phase 1/2 trials for its lead product and to present its proposed phase 3 trial.

The meeting, for Novelos' NOV-002 treatment for non-small cell lung cancer, is with the FDA's Center for Drug Evaluation and Research, Division of Oncology Drug Products.

Novelos is asking to conduct the phase 3 study of NOV-002 in combination with chemotherapy under a Special Protocol Assessment.

In addition, the company will review "positive" phase 1/2 tumor response data for patients with non-small cell lung cancer.

In the phase 1/2 study in the United States, patients showed improved tumor response - defined as a greater than 50% shrinkage - compared to the control group as well as higher tolerance of chemotherapy.

The drug already is marketed in Russia by an unrelated company and a study in that country found it increased the one-year survival rate to 63% from 17%.

Novelos is a Newton, Mass., biotechnology company focused on oxidized glutathione for use in fighting cancer and hepatitis.

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