SOMERSET, N.J., Jan. 27 /PRNewswire-FirstCall/ -- Alfacell Corporation (OTC Bulletin Board: ACEL) today reported that it has conducted a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) to discuss the company's planned submission of the final components of the ONCONASE rolling New Drug Application (NDA) for the treatment of unresectable malignant mesothelioma (UMM) patients. At the pre-NDA meeting, the FDA provided guidance to the company recommending that an additional clinical trial be conducted in UMM patients that have failed one prior chemotherapy regimen, prior to submitting a NDA.
As the company has previously reported, the results of the preliminary statistical analysis of the data from the confirmatory Phase IIIb clinical trial for ONCONASE in patients suffering from UMM did not meet statistical significance for the primary endpoint of survival in UMM. However, a statistically significant improvement in survival was seen in the treatment of UMM patients who failed one prior chemotherapy regimen, a pre-defined primary data set for this sub-group of patients in the trial, which represents a currently unmet medical need.
The company's current financial situation does not allow it to pursue additional clinical trials until other sources of capital are secured. The company will effect a reduction in force on January 30, 2009 and otherwise reduce its operations to the minimum sustainable level required to pursue strategic alternatives and additional capital. Based upon these actions the company expects that its current cash reserves will enable it to maintain its reduced operations through December 2009. The company intends to continue to explore strategic alternatives and additional capital. Additionally, the company's board of directors has agreed to forgo cash compensation effective as of January 1, 2009.
ONCONASE is a first-in-class therapeuti
|SOURCE Alfacell Corporation|
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