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

rienced a MST of 10.5 months compared with 8.7 months for those patients who received doxorubicin (unadjusted log rank p=0.016).

"I am pleased that we have reached this important milestone for both Alfacell and ONCONASE," said Kuslima Shogen, Alfacell's chief executive officer. "We are deeply appreciative of the cancer patients and clinical investigators who participated in this important trial."

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. Pending completion of the analysis of the data and further discussions with the FDA, the company currently estimates that the NDA submission will be completed by the end of calendar year 2008.

Alfacell has licensed the U.S. commercial rights for ONCONASE to Strativa Pharmaceuticals, a division of Par Pharmaceutical, Inc. Strategic marketing and distribution agreements for ONCONASE have been secured with BL&H Co. Ltd. for Korea, Taiwan and Hong Kong, USP Pharma Spolka Z.O.O., an affiliate of US Pharmacia, for Eastern Europe, and GENESIS Pharma, S.A. for Southeastern Europe.

ONCONASE has been granted fast track status and orphan-drug designation for the treatment of malignant mesothelioma by the FDA. Additionally, ONCONASE has been granted orphan-drug designation in the European Union and Australia.

Conference Call & Webcast

Alfacell will host a conference call and Webcast to discuss the preliminary results at 8:30 a.m. EDT on Thursday, May 29. To participate in the live conference call, U.S. residents may dial 1-877-407-9205, and international callers may dial 1-201-689-8054. A replay of the call will be available until June 5. To access the replay, U.S. residents may dial 1-877-660-6853, and international callers may dial 1-201-612-7415 and enter account number 286 and conference ID number 284844. A live Webcast and replay of the conference call will be available on Al
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SOURCE Alfacell Corporation
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