Members of the FDA met with Alfacell Corp. to discuss the final components of the Onconase New Drug Application (NDA). The company plans to submit an application for the treatment of unresectable malignant mesothelioma and was advised to conduct an additional clinical trial before submission.
The FDA recommended the company conduct a trial on patients with unresectable malignant mesothelioma who have failed one prior chemotherapy regimen. However the company is unable to conduct an additional clinical trial at this time because it requires an additional source of capital to continue development.
Earlier this year, the company released the results of their Phase IIIb clinical trial for Onconase. The trial results did not meet statistical significance for primary endpoint survival for patients with unresectable malignant mesothelioma. However participants who failed one-prior chemotherapy regimen before the clinical trial saw a statistically significant improvement.
Alfacell Corp. announced that it has begun seeking alternative sources of funding and has begun reducing staff and compensation in order to continue basic operations.