ALFACELL WILL FILE IND FOR ANTICANCER BIOLOGICAL PANNON,
ALFACELL WILL FILE IND FOR ANTICANCER BIOLOGICAL PANNON, the company announced Aug. 12, after meeting with FDA's Center for Drugs and Biologics in a prefiling conference to discuss details of the proposed study. The filing will reportedly take place in eight to ten weeks, and the company is planning to conduct a multi-center trial in the U.S. The release noted that Alfacell's pre-filing conference with FDA was based on a clinical study conducted in the Domenican Republic, in which 27 terminal cancer patients were treated with Pannon. According to Dr. Angel S. Chan Aquino, former Domenican Minister of Health and director of the clinical trial, all patients "showed significant malignant cell destruction." It has also been reported that the drug did not produce any significant side effects.
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