ALFACELL MESOTHELIOMA DRUG GRANTED ORPHAN DESIGNATION

Alfacell announced that the FDA has granted orphan drug designation to the company's lead drug candidate, Onconase (ranpirnase), for treatment of 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. Other benefits for which Alfacell is eligible include protocol assistance by the FDA in the preparation of a dossier that will meet regulatory requirements, tax credits, R&D funding and reduced filing fees for the marketing application.

"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," Kuslima Shogen, the company's chairman and CEO, said.

Onconase is a first-in-class therapeutic from Alfacell's proprietary ribonuclease technology platform. The drug has been shown in vitro and in vivo to target tumor cells while sparing normal cells. Onconase is internalized by endocytosis and released into the cytosol of the cancerous cell, where it selectively degrades tRNA beyond repair. In doing so, the drug inhibits protein synthesis, stops cell cycle proliferation and induces apoptosis.

In addition to the ongoing confirmatory registration study in malignant mesothelioma, the company is conducting an Onconase in non-small-cell lung cancer and other solid tumors.