Alfacell Provides ONCONASE(R) NDA Submiss...( SOMERSET N.J. Dec. 5 /- Alfacell Corp...),Health

SOMERSET, N.J., Dec. 5 /PRNewswire-FirstCall/ -- Alfacell Corporation (Nasdaq: ACEL) today reported that the U.S. Food and Drug Administration (FDA) has scheduled a pre-NDA meeting date at the end of January 2009 for discussion of 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. The pre-NDA meeting is an important step to complete prior to the planned submission of the final components of the ONCONASE rolling NDA for patients that have failed prior chemotherapy. Therefore, the final components of the rolling ONCONASE NDA will not be finalized until Alfacell receives guidance from the FDA at the pre-NDA meeting. Alfacell expects to provide an update on the planned completion of the rolling NDA within 48 hours of the conclusion of the pre-NDA meeting.

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.

Since receiving the results of this preliminary statistical analysis in late May 2008, the company engaged in an extensive and careful review of the data to submit to the FDA prior to the pre-NDA meeting. While preparations of materials for the pre-NDA meeting have taken more time than expected, by submitting the pre-NDA meeting request on October 3, 2008, Alfacell had anticipated that the pre-NDA meeting wo
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