"Fiscal 2008 was a year of progress at Alfacell," said Lawrence A. Kenyon, Alfacell's president. "We achieved a number of important objectives, including the U.S. license agreement with Strativa and completion of the Phase IIIb clinical trial for ONCONASE in UMM. In fiscal 2009, we plan to complete the NDA submission after receiving input from the FDA and to move forward with an expanded ONCONASE clinical development program."
ONCONASE is a first-in-class therapeutic product candidate based on Alfacell's proprietary ribonuclease (RNase) technology. A natural protein isolated from the leopard frog, ONCONASE has been shown in the laboratory and clinic to target cancer cells while sparing normal cells. ONCONASE triggers apoptosis, the natural death of cells, via multiple molecular mechanisms of action.
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 Megapharm Ltd. for Israel, 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.
About Alfacell Corporation
Alfacell Corporation is the first company to advance a
biopharmaceutical product candidate that works in a manner similar to RNA
interference (RNAi) through late-stage clinical trials. The product
candidate, ONCONASE, is an RNase that overcomes the challenges of targeting
RNA for therapeutic purposes while enabling the development of a new class
of targeted therapies for cancer and other life-threaten
|SOURCE Alfacell Corporation|
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