Pharmaceutical company Alfacell Corp. will extend the time for its Phase IIIb clinical trial of its potential mesothelioma treatment drug, Onconase. Enrollment is scheduled to close on Sept. 30, and 425 mesothelioma patients have been enrolled in the study so far. The study plan provides that statistical analysis cannot be performed until 316 “evaluable events”–or deaths meeting certain criteria–have occurred. Although 316 deaths have occurred, only 290 meet the criteria for evaluable events. Alfacell expects that it will meet the study criteria and begin the statistical analysis by the end of the year. Once the required statistical analysis is complete, Alfacell will prepare and submit a New Drug Application. Onconase is made from a protein isolated from the leopard frog, and studies in the laboratory have shown that the drug will target cancer cells.
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