With no near-term promise of Genasense reaching the market for melanoma, Genta Inc. and Aventis SA terminated the expanded access program for the drug.
"The original intention was to make Genasense available to eligible patients in advance of the near-term approval," said Joy Schmitt, spokeswoman for Berkeley Heights, N.J.-based Genta.
But an FDA advisory panel hurt those plans earlier this month when it voted against recommending the injection therapy. Genta withdrew its NDA for Genasense (oblimersen sodium), which was to be used in combination with dacarbazine.
Despite a falling stock price, the companies plan to continue their focus on getting the drug approved. It remains in more than 20 clinical trials, with the most advanced being Phase III trials for chronic lymphocytic leukemia and multiple myeloma. Schmitt said data from those trials would be made public in the second half of this year.
"We continue to develop Genasense with the ultimate objective of obtaining marketing approval," she told BioWorld Today.
Aventis spokeswoman Marisol Peron said the pharmaceutical company fully intends to continue its partnership with Genta. "We are obviously pursuing working with the FDA and Genta to answer any questions," she said.
Although Genasense became accepted into the expanded access program in April, no patients received the drug in that short time, Peron said.
Genasense was first identified in 1992 and entered the clinic in 1995. The partnership with Strasbourg, France-based Aventis was formed in April 2002. The FDA panel said it rejected the NDA because small improvements in tumor response rates and progression-free survival do not warrant approval given the increased chance of toxicity. (See BioWorld Today, May 4, 2004.)
Subsequently, Genta pulled the NDA and announced plans to reduce its staff.
"We are a company now of about 100 people" following the layoffs, Schmitt said. "It was a reduction of approximately 45 percent of our job force."
The company also recently halted all active promotion of its only marketed drug, Ganite (gallium nitrate injection) to treat cancer-related hypercalcemia because it generated less revenues than it cost. And Genta has become the defendant in several class action lawsuits filed by shareholders.
Before the FDA panel's rejection of Genasense, the company's stock (NASDAQ:GNTA) was closing as high at $14.63. It closed on Friday at $2.30, down 4 cents.