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Alfacell Corporation Announces Preliminary Results From ONCONASE(R) Phase IIIb Clinical Trial
Date:5/28/2008

- Company to Host Conference Call/Webcast at 8:30 a.m. EDT on May 29 -

SOMERSET, N.J., May 28 /PRNewswire-FirstCall/ -- Alfacell Corporation (Nasdaq: ACEL) today announced that the preliminary statistical analysis of data from its confirmatory Phase IIIb clinical trial of its lead compound, ONCONASE (ranpirnase), did not meet statistical significance for the primary endpoint of survival in unresectable malignant mesothelioma (UMM). However, a statistically significant improvement in survival was seen in the treatment of UMM patients who failed one prior chemotherapy regimen. Alfacell plans to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the treatment of this patient population, which represents a currently unmet medical need.

The preliminary results are based on 320 evaluable events that occurred in the clinical trial out of a total of 428 patients randomized. The trial was designed to show a statistically significant improvement in overall survival (p < 0.048) for UMM patients who were treated with a combination of ONCONASE plus doxorubicin as compared to patients who were treated with doxorubicin as a single agent. The analysis of the data did not show a statistically significant improvement for evaluable patients receiving ONCONASE plus doxorubicin (unadjusted log rank p=0.80). The median survival time (MST) for evaluable patients who received ONCONASE plus doxorubicin was 11.1 months as compared to 10.7 months for patients who received doxorubicin as a single agent.

Statistically significant results were achieved in evaluable UMM patients (N=122) who failed a prior chemotherapy regimen before entering this clinical trial. Patients who received ONCONASE plus doxorubicin expe
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SOURCE Alfacell Corporation
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