Alfacell is evaluating Onconase in a confirmatory phase IIIb clinical trial in unresectable malignant mesothelioma.
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.
Other benefits for which Alfacell is eligible with the orphan drug designation include protocol assistance by the FDA in the preparation of a dossier that will meet regulatory requirements; tax credits, research and development grant funding, and reduced filing fees.
Malignant mesothelioma qualifies under orphan drug designation because approximately 4,000 to 5,000 new cases are reported in the US each year.