Shares of Genta (GNTA) surged more than 20% after the cancer-drug developer said regulators agreed to the design of a proposed trial for its experimental leukemia treatment.
The Food and Drug Administration completed a special protocol assessment of the proposed trial, which will enroll patients with symptomatic chronic lymphocytic leukemia who have not previously received chemotherapy.
The trial will compare the results of patients who receive the chemotherapy drug fludarabine plus Genentech's (DNA) Rituxan with and without Genta's treatment, Genasense.
Last month, an FDA oncology drug advisory committee voted against approving a new drug application for Genasense. Although the FDA isn't required to follow the advice of its advisory committee, it often does. A decision from the FDA is expected Oct. 29.The trial supporting the company's application involved a combination of the chemotherapies fludarabine plus cyclophosphamide with or without Genasense in patients with CLL whose condition has gotten worse. "We are pleased that the FDA had no outstanding issues regarding the design or analysis of this trial, and also with the agency's agreement that there were no safety issues that precluded the use of Genasense in previously untreated patients," said Genta's CEO Dr. Raymond Warrell. Warrell says the company will not decide on whether to go through with the trial until the company has met with the FDA to review the status of its drug application. The stock gained 20.1% to 96 cents in premarket trading Friday. More recently, shares were trading up 7 cents, or 9.4%, at 88 cents.