Alfacell Says Onconase Clinical Trial Enrollment Expected to Be Ahead of Schedule
Associated Press, January 30, 2006
BLOOMFIELD, N.J. (AP) -- Biopharmaceutical company Alfacell Corp. said Monday that it expects to fully enroll its late-stage cancer drug trial ahead of schedule.
Alfacell shares rose $1.71, or 52.1 percent, to a new 52-week high of $4.99 in morning trading on the Nasdaq.
The clinical trial seeks to test Onconase for the treatment of unresectable malignant mesothelioma, a rare form of cancer linked to asbestos exposure that occurs in the sac lining of the chest, the abdomen, or the lining of the heart that cannot be surgically removed. The company expects to enroll 316 patients before the end of the first quarter, ahead of schedule.
The company said it plans to try to parlay its fast track designation from the Food and Drug Administration into an expedited review of its marketing application.
A fast track designation allows a company to submit data to the FDA as it becomes available, and receive feedback, rather than having to wait until the end of the trial and submit it all at once. An expedited review is granted by the agency if the company can show a pressing public health need for a given treatment.