About Institute

Burzynski Research Institute (BRI) is based in Houston and Stafford, Texas, U.S.A., and is engaged in research and development of targeted gene therapies (antineoplastons or ANP) for the treatment of cancer. BRI was incorporated under the laws of the State of Delaware in 1984 in order to engage in the research, production, marketing, promotion and sale of certain medical chemical compounds composed of growth-inhibitig peptides, amino acid derivatives and organic acids which are known under the trade name antineoplastons.

BRI believes ANP are useful in the treatment of human cancer, and is currently conducting Phase II clinical trials of ANP relating to the treatment of cancer. ANP have not been approved for sale or use by the Food and Drug Administration of the United States Department of Health and Human Services (“FDA”) or anywhere in the world.

In the event ANP receives such approval and are registered in the United States, Canada, or Mexico, of which there can be no assurance, BRI will commence commercial operations, which shall include the production, marketing, promotion and sale of ANP in the United States, Canada, or Mexico. In 2004, the FDA approved the designation of ANP as an “orphan drug” under the Orphan Drug Act of 1983, for the treatment of brainstem glioma. In 2008, ANP orphan drug designation by the FDA was extended to all gliomas. It is estimated that in 2009 more than 21,000 men and women in the U.S., will be diagnosed with glioma, with prevalence estimated at approximately 84,000 cases.

Orphan Drug Designation is granted by the FDA’s Office of Orphan Drug Products Development, and is 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 credit.