FDA Approves Mesothelioma Treatment

February 6, 2007 - The U.S. Food and Drug Administration (FDA) announced today that Alfacell Corporation, a biopharmaceutical company focused on cancer research, has been granted orphan-drug designation in the United States for the company's lead drug candidate, ONCONASE® (ranpirnase), for treatment of malignant mesothelioma. Alfacell is now evaluating the drug in clinical trials for the deadly disease.

According to Kuslima Shogen, Alfacell's chairman and chief executive officer, "Orphan-drug designation in the United States is an important milestone for malignant mesothelioma patients." The CEO added, "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.

Because less than 200,000 people in the United States are affected each year, the FDA orphan drug designation gives incentives to pharmaceutical and biotechnology companies to develop drugs for the treatment of diseases. In the US, Malignant mesothelioma qualifies under this requirement since roughly 4,000 to 5,000 new cases are reported annually.

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