Genta Inc.'s decision to reduce its work force as a way of focusing on the melanoma therapy Genasense, combined with the simultaneous move to withdraw the new drug application for that lead product, "might be confusing from an external perspective," conceded Joy Schmitt, spokeswoman for the company.
But the Berkeley Heights, N.J.-based firm has a plan, she said, even if that plan is largely dependent on the FDA.
Genta on Thursday said it was laying off half its staff to conserve money for Genasense (oblimersen sodium), which an FDA advisory panel had voted against. The same day of the layoff news, after the market closed, Genta said it was taking back the NDA for Genasense for use in combination with dacarbazine that was submitted late last year. (See BioWorld Today, May 14, 2004.)
The company's stock (NASDAQ:GNTA) closed Friday at $4.52, down 33 cents, having taken its bigger hit earlier in the week. Genasense, an antisense drug that targets the Bcl-2 protein to boost chemotherapy, is partnered with Strasbourg, France-based Aventis SA, which owns rights outside the U.S.
"Until the next steps are defined with the FDA, there's nothing I can say about timelines," Schmitt told BioWorld Today. "But we have more than 20 ongoing clinical trials with Genasense and they are all active."
Two other Phase III trials have completed accrual, she noted - one in chronic lymphocytic leukemia and one in multiple myeloma. The next step with Genasense will be determined by the outcome of talks with the FDA regarding melanoma, she said.
Meanwhile, the company has decided to quit promoting its only marketed product, Ganite (gallium nitrate), an injected therapy for cancer-related hypercalcemia that is resistant to hydration, because the cost outweighed revenues. Ganite brought in $400,000 in the quarter ended March 31.
"We had always realized that the current potential with the indication was limited," Schmitt said. "The idea was to develop that more fully in, say, non-Hodgkin's lymphoma." Now, though, she characterized the clinical program for Ganite as "under review."