Shares of Alfacell Corporation (NASDAQ: ACEL), a biopharmaceutical company engaged primarily in the research and development of novel ribonuclease (RNase) enzymes for various therapeutic applications, declined sharply last week after the company released the preliminary Phase IIIb trial results of its lead compound ONCONASE®. The findings concluded that the compound did not meet statistical significance for the primary endpoint of survival in unresectable malignant mesothelioma (UMM).

The Phase IIIb trial was designed to show a statistically significant improvement in overall UMM patient survival (p < 0.048) for those treated with a combination of ONCONASE® plus doxorubicin compared with patients treated with doxorubicin as a single agent. The conclusion of the trial did not show a statistically significant improvement for patients receiving ONCONASE® plus doxorubicin (unadjusted log rank p=0.80). The company believes that its preliminary top line data still provides a clear pathway for UMM research and will continue to analyze the preliminary Phase IIIb results to fully understand the nuances of the trial. Based on the preliminary statistical analysis of the data, Alfacell will continue with the planned submission of the remaining components of the ONCONASE® rolling NDA and currently estimates that the NDA submission will be completed by the end of calendar year 2008. Let us hear your thoughts below: