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Alfacell: Malignant mesothelioma treatment trial fails to meet primary endpoint

Thursday, May 29th, 2008.

Alfacell Corp. late Wednesday said results from its Phase IIIB clinical trial for Onconase, which was being studied as a potential treatment for unresectable malignant mesothelioma, didn’t meet the trial’s primary endpoint.

The Somerset, N.J.-based biopharmaceutical company said a statistically significant improvement in survival was seen in the treatment of UMM patients who failed one prior chemotherapy regimen. Alfacell said it will submit a new drug application to the Food and Drug Administration for the treatment of this patient population.

The Phase IIIB trial was designed to show a statistically significant improvement in overall survival for patients treated with a combination of onconase plus doxorubicin versus patients treated with doxorubicin alone.

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Last Updated: April 23, 2008. 05:10:55 pm.