Mesothelioma drug Onconase status update
Alfacell Corp. reported recently that company executives have met with officials from the U.S. Food and Drug Administration. At that meeting, FDA officials recommended that before the New Drug Application is submitted for Onconase, the drug should be subjected to another clinical trial involving patients with malignant mesothelioma that cannot be treated surgically (unresectable) and who have already failed a course of chemotherapy.
A prior Phase IIB clinical trial showed that, while Onconase treatment did not result in a statistically significant improvement in survival for patients with unresectable mesothelioma overall, Onconase treatment was correlated with a significantly significant improvement in survival for patients with unresectable disease who have already failed a course of chemotherapy.
The company reports that it cannot finance an additional clinical trial unless it is able to secure outside capital. Alfacell is undergoing a reduction in force and operations. The company anticipates that its current cash reserves will be able to sustain scaled-down operations until December 2009.
Read more in the Alfacell Press Release.
