ONCONASE Granted U.S. Orphan Drug Designation

February 19, 2007 - According to a press release issued by drug manufacturer Alfacell Corporation, the U.S. Food and Drug Administration (FDA) has granted orphan drug designation in the United States for the company's lead drug candidate, ONCONASE® (ranpirnase), for treatment of malignant mesothelioma. Alfacell is currently evaluating ONCONASE in a confirmatory Phase IIIb clinical trial in unresectable malignant mesothelioma (UMM) patients.

The release notes that orphan drug designation permits Alfacell “to be awarded seven years of marketing exclusivity for ONCONASE for the malignant mesothelioma indication upon FDA approval for this indication.”

"Orphan-drug designation in the United States is an important milestone for everyone associated with Alfacell, including malignant mesothelioma patients, investors and employees," said Kuslima Shogen, the company's chairman and chief executive officer. "This designation represents recognition of the potential of our lead drug candidate by the FDA, in addition to the previously granted fast-track development status in the United States, as well as the orphan-drug designations received in Europe and Australia for malignant mesothelioma. Moreover, it's a significant event for us in what is a transformational year for our company."

Mesothelioma qualifies as an orphan disease because it affects less than 200,000 people in the U.S. About 4,000 to 5,000 new cases of malignant mesothelioma are diagnosed in the U.S. each year.