Alfacell has completed patient enrollment in a confirmatory Phase IIIb clinical trial for ONCONASE in patients suffering from unresectable malignant mesothelioma (UMM) and reached the required number of evaluable events to conduct the formal statistical analyses required to complete the final sections of the ONCONASE rolling NDA. As the company has previously reported, the results of the preliminary statistical analysis of the data 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. Alfacell has requested a pre-NDA meeting with the Food and Drug Administration (FDA) to discuss the details of the planned NDA submission. The company continues to estimate that the final components of the rolling NDA will be submitted by the end of 2008, and the company plans to present the results of the Phase IIIb trial at an upcoming scientific conference in 2009.
The company has completed enrollment in its Phase I clinical trials for
patients suffering from non-small cell lung cancer (NSCLC) and other solid
tumors and is planning for a follow-on Phase II clinical trial in NSCLC
patients that exhibit resistance to platinum based chemotherapy regimens.
Initiation of patient enrollment in this tria
|SOURCE Alfacell Corporation|
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