ONCONASE TRIAL FAILS TO MEET PRIMARY ENDPOINT
Late yesterday, Alfacell Corp. reported that the Phase IIIB clinical trial for Onconase failed to meet the trial's primary endpoint. Onconase was being studied as a potential treatment for unresectable malignant mesothelioma (UMM).
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. The Company are to 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 doxorubicin alone.
