Genasense hits primary endpoint in late-stage cancer trial

Genta stock surged on the news that an extended follow-up of its Phase III trial of its oncology drug Genasense--in combination with chemotherapy--demonstrated positive data for keeping patients in remission and reducing the number of relapses for chronic lymphocytic leukemia. The trial achieved its primary endpoint, which was a statistically significant increase in the proportion of patients who achieved a complete or nodular partial response (17 percent vs. 7 percent, respectively). Genta says it should be able to file for marketing approval by the end of the year as planned, and it is in talks with the FDA on designing a Phase IV post-marketing trial. Genta plans to request an accelerated approval of the drug.

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