The USFDA has granted orphan-drug designation in the United States for the Alfacell Corporation (Nasdaq: ACEL)’s lead drug candidate, ONCONASE® (ranpirnase), for treatment of malignant mesothelioma.
Currently being evaluated in a confirmatory Phase IIIb clinical trial in unresectable malignant mesothelioma (UMM), ONCONASE® is a first-in-class therapeutic from Alfacell's proprietary ribonuclease (RNase) technology platform, which have demonstrated both in vitro and in vivo to be able to target tumor cells while sparing normal cells.
The orphan drug designation enables Alfacell to be awarded seven years of marketing exclusivity for ONCONASE for the malignant mesothelioma indication once the indication has been approved by the FDA.
Find more details from the press release.
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