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Progress on Clinical Development Program for ONCONASE(R) in Malignant Mesothelioma
BLOOMFIELD, N.J., Aug. 31, 2006/PRNewswire-FirstCall/ -- Alfacell Corporation announced today an update regarding the ongoing randomized, multi-center, multi-national, confirmatory Phase IIIb registration study for its lead anti-cancer drug, ONCONASE(R) (ranpirnase). This pivotal trial is evaluating the effectiveness of ONCONASE plus doxorubicin in improving the survival of patients with unresectable malignant mesothelioma (UMM) over doxorubicin alone.
The Company's Chief Executive Officer and Chairman of the Board of Directors, Kuslima Shogen, commented, "As a result of our recently completed financing we are in a strong position to further accelerate our clinical and regulatory strategy for ONCONASE. To date, we have accrued more than 360 patients, and are awaiting the 316 events required to trigger the final analysis. We look forward to completing the study and to adhering closely to our desired critical path, which centers on positive results from the final analysis leading to the filing of an NDA."
Shogen stated, "ONCONASE has previously been granted Fast Track status by the FDA for UMM, which allows us the opportunity to submit sections of an NDA as they are prepared. As such, we are continuing to finalize components of the Chemistry Manufacturing and Controls (CMC) section, which we plan to submit by end of third quarter 2006."
Shogen concluded, "Overall, we are pleased with the consistent progress the Company has made in the ONCONASE UMM clinical program, and that we remain on track with our previously stated timelines. We look forward to providing future updates on our progress toward marketing approval, as well as ongoing and new ONCONASE trials in major cancers."