Burzynski Research Institute Partners with Premier Research to Manage Phase III Clinical Study of Children with Newly-Diagnosed Diffuse Intrinsic Brainstem Glioma.

HOUSTON -- The Burzynski Research Institute, Inc. (BRI) today announced that it has partnered with Premier Research, a global clinical research services provider, to initiate and manage a pivotal Phase III clinical trial of combination antineoplaston therapy (ANP) plus radiation therapy in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma.

Premier Research is currently conducting a feasibility assessment. A number of academic centers in the U.S. and Europe will be considered, including Houston-based academic centers specializing in the treatment of pediatric brain tumors. To date, Premier has secured interest and commitment from a number of sites selected. Upon completion of this assessment, a randomized, international Phase III study will commence.

The study's objective is to compare overall survival of children with newly-diagnosed, diffuse, intrinsic brain stem glioma (DBSG) who receive combination antineoplaston therapy [Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal)] plus radiation therapy (RT) versus RT alone. Antineoplaston therapy (ANP) uses a synthetic version of naturally occurring peptides and amino acid derivatives found in the human body to target and control cancer cells without destroying normal cells.

BRI recently announced that it had reached an agreement with the U.S. Food and Drug Administration (FDA) enabling it to move forward with a Phase III study. The agreement was made under the FDA's Special Protocol Assessment (SPA) procedure and means that the design and planned analysis of the study is acceptable to support a regulatory submission seeking new drug approval.

"With the feasibility study underway we continue to move forward in accordance with our clinical development plan to bring antineoplaston therapy to market for the treatment of a disease with such a poor prognosis," said Stanislaw R. Burzynski, M.D., Ph.D. "In tandem with the commencement of this pivotal study, we remain engaged in numerous phase II studies for other malignancies and tumor types and feel very encouraged by the building body of evidence for antineoplaston therapy."

Premier Research delivers high quality clinical trial services for biopharmaceutical and medical device companies and has a successful track record providing services for covering a wide spectrum of cancer-related therapeutic indications. Premier Research's oncology expertise ranges from small dose findings and proof-of-concept studies to large multi-national Phase III trials and as such is well suited to partner with BRI on this study. In addition to oncology, the company leads in the management of clinical research for analgesia, CNS and infectious disease and has deep experience in medical device and pediatric research. Premier Research maintains a well-established network of dedicated clinical sites, with 30 offices and operations in more than 30 countries throughout North America and Europe.

Burzynski Research Institute, Inc. (OTCBB: BZYR) is a biopharmaceutical company committed to developing treatment for cancer based on genomic and epigenomic principles. Research and development efforts are focused on basic ANP research and 19 Phase II clinical trials.

Forward-looking statements in this release are made pursuant to the safe harbor provisions of the federal securities laws. Burzynski Research Institute, Inc. cautions investors not to place undue reliance on the forward-looking statements contained in this press release. Information contained in forward-looking statements is based on current expectations and is subject to change, and future events may differ materially from those discussed herein due to a number of factors, including, but not limited to, risks and uncertainties related to BRI's ability to obtain regulatory approval for Antineoplastons A10 and AS2-1, risks associated with BRI's ability to raise sufficient capital from the development of its technology towards commercialization, and other risks described in BRI's periodic reports filed with the Securities and Exchange Commission. BRI does not undertake to update any such forward- looking statements or to publicly announce developments or events relating to the matters described herein.