Alfacell Reports Financial Results for Third Quarter of F...(ned completion of the ONCONASE rollingND...)

Date:6/9/2008

ned completion of the ONCONASE rolling NDA. The company will be eligible to receive a minimum milestone payment of $20 million, up to a maximum of $30 million, from its U.S. partner, Strativa Pharmaceuticals, in the event that the NDA submission results in the company receiving marketing approval for ONCONASE.

Clinical Trials Update

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. 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. The company plans to present the results of the trial at an upcoming scientific conference.

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 now currently planning for the follow-on Phase II clinical trials.

"The completion of our fiscal third quarter marks the point where we have entered the most important phase for the commercialization of ONCONASE," said Lawrence A. Kenyon, Alfacell's president. "We are moving forward with the completion of our rolling NDA and appreciate the support expressed by our partners around the world for pursuing a U.S. approval for O
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