Friday, October 06, 2006

Biotech drug maker Genta Inc. said Friday it completed designing a clinical trial with the Food and Drug Administration for the use of its cancer drug along with other drugs to treat leukemia.
Shares of Genta rose 14 cents, or 17.5 percent, to 94 cents in pre-market activity on the INET electronic exchange, after closing at 80 cents on the Nasdaq Thursday. Shares have traded between 35 cents and $3.48 over the past 52 weeks.

The company said it completed a Special Protocol Assessment with the agency, meaning it sat down with officials to design a study that is most likely to yield the best results. Genta first submitted the SPA in December.

Genta hopes to get approval for Genasense for use with other therapies to treat chronic lymphocytic leukemia. In September, however, an FDA advisory panel voted to not recommend the drug for approval. The FDA is required to make a decision on the drug by Oct. 29.

The new clinical trial design involves enrolling patients who have not received chemotherapy before and giving them a combination of the chemotherapy fludarabine and Genentech Inc.'s therapeutic antibody Rituxan with or without Genasense.

The company said it will not make a decision on whether to proceed with the new trial until it has met with the FDA to discuss the status of its current marketing application.

Genta had previously tried to get the drug approved for advanced skin cancer, but an FDA advisory panel recommended against it in 2004, and the company withdrew the marketing application.

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