BLOOMFIELD, N.J.--(BUSINESS WIRE)--Alfacell Corporation (NASDAQ: ACEL) today announced that the company has completed the non-clinical section of the rolling submission of a New Drug Application (NDA) in preparation for its submission to the U.S. Food and Drug Administration (FDA) for its lead anticancer compound, ONCONASE (ranpirnase). ONCONASE, first in class in the ribonuclease family, is currently the subject of a randomized Phase III clinical trial in combination with doxorubicin as a potential treatment for patients with unresectable malignant mesothelioma (UMM). The company will submit the chemistry, manufacturing and controls (CMC) section of the NDA after completion of a review by external regulatory consultants. The company anticipates completing the NDA submission for ONCONASE in combination with doxorubicin pending the review of final results of the ongoing Phase III trial in 2007.
