The Food and Drug Administration (FDA) has recommended that Alfacell have its drug ONCONASE undergo one more clinical trial before having its rolling New Drug Application (NDA) submitted. The drug is used to treat those with unresectable malignant mesothelioma (UMM) who have failed at least one other chemotherapy treatment in the past.
Alfacell had reported that its findings from its Phase IIB clinical trials did not show a significant number of UMM patients who improved with the drug, but a statistical significance was found in the subset of those who were taking ONCONASE and who had failed at least one other chemotherapy treatment before.
As a result of these trials, the FDA is requesting that another clinical trial be performed on this second, successful group. Without the additional trial, it is unlikely that ONCONASE’s rolling NDA will be approved. As of the FDA recommendation at the end of January 2009, Alfacell lacked the immediate funds to pursue further clinical trials. On January 30, Alfacell implemented methods to free up the needed capital for the trials. These methods included layoffs and a reduction in the amount of work done to a bare minimum for functioning. The board of directors for Alfacell agreed to go without pay from January 1, 2009. With these measures in place, Alfacell estimated that it could continue with a reduction in its operations through the end of 2009. ONCONASE has been shown to be a unique cancer drug in the manner it targets cancer cells while leaving healthy cells intact. Much hope for cancer patients has been wrapped up in this drug derived from a protein from the leopard frog. ONCONASE has already been granted orphan drug status, allowing the drug to be used in patients with very rare, life threatening diseases, such as malignant mesothelioma. It is also on the fast track to hasten its approval.