BURZYNSKI RESEARCH INSTITUTE INC

General Burzynski Research Institute, Inc. researches, produces, markets, promotes, and sells medical chemical compounds known as "Antineoplastons." These compounds are composed of growth-inhibiting peptides, amino acid derivatives, and organic acids. The company believes Antineoplastons are useful in treating human cancer and is currently reviewing data from its Phase II clinical trials for various cancers. Antineoplastons have not been approved for sale or use by the Food and Drug Administration (FDA) in the United States or anywhere else globally. If Antineoplastons receive approval and are registered in the United States or Canada, the company plans to begin commercial operations, including production, marketing, promotion, and sale in those countries. In 2004, the FDA designated Antineoplastons as an "orphan drug" under the Orphan Drug Act of 1983. Currently, the company provides Antineoplastons exclusively for use by Stanislaw R. Burzynski, M.D., Ph.D., in clinical research. The company has not generated significant operating revenue since its inception. Its operations are funded solely by payments from Dr. Burzynski, derived from his medical practice, which are reported as additional paid-in capital. The company does not anticipate significant operating revenue until Antineoplastons are approved for use and sale by the FDA, but it may seek additional funding through the sale of its securities.