BLOOMFIELD, N.J., Jan. 30 (UPI) -- U.S. firm Alfacell said Tuesday it has been granted orphan drug status for its treatment Onconase for malignant mesothelioma.
The company said it is currently testing the first-in-class RNAi drug in a phase 3b confirmatory trial in patients with unresectable forms of the disease.
The Food and Drug Administration grants orphan drug status to treatments for serious diseases affecting fewer than 200,000 people in the United States. The designation means that, if approved, the company could get seven years' market exclusivity for the treatment.
"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, Alfacell's chairman and CEO.
"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."
