The Burzynski Research Institute, Inc. (BRI) has announced that its antineoplaston A10 and antineoplaston AS2-1 therapy (ANP) has been granted orphan drug designation by the U.S. Food and Drug Administration ("FDA") for the treatment of gliomas. It is estimated that in 2008 more than 21,000 men and women in the U.S. will be diagnosed with this type of cancer, with prevalence estimated at approximately 84,000 cases.
"We are encouraged by the FDA's action. Initially, BRI sought orphan drug designation for ANP in optic pathway glioma in children, a much narrower indication involving a smaller segment of tumors," said Dr. Stanislaw R. Burzynski, M.D., Ph.D. "However, the FDA extended orphan drug designation to all gliomas, a recognition we believe underlies the broad potential of anitneoplaston therapy for the treatment of patients with cancer of the brain and nervous system. There is now even more motivation for us to evaluate our therapy as an innovative and efficacious choice in a treatment spectrum where disease management options are still quite limited."
Orphan drug designation, as granted by the FDA's Office of Orphan Products Development, was designed to encourage clinical development of products for use in rare diseases or conditions, usually defined as affecting fewer than 200,000 people in the United States. Orphan drug designation provides an economic incentive that stimulates the development of new products in the oncology field and allows for seven years of market exclusivity upon final FDA approval, as well as clinical study and R&D support, reduction in regulatory fees and potential tax credits.