Burzynski Research Institute Gets SPA Clearance from the FDA to Initiate Pivotal Phase III Trial of Combination Antineoplaston Therapy and Radiation Therapy

Study to Evaluate Children with Newly-Diagnosed Diffuse Intrinsic Brainstem
Glioma
HOUSTON--(Business Wire)--
The Burzynski Research Institute, Inc. (BRI) today announced that it has reached
an agreement with the U.S. Food and Drug Administration (FDA) that enables the
company to move forward immediately with a pivotal Phase III clinical trial of
combination antineoplaston therapy plus radiation therapy in patients with
newly-diagnosed, diffuse, intrinsic brainstem glioma. 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. The agreement was made under the FDA's Special Protocol
Assessment (SPA) procedure and means that the design and planned analysis of the
Phase III study is acceptable to support a regulatory submission seeking new
drug approval.

"We are very pleased by our agreement with the FDA to move forward with a
confirmatory study on a type of tumor that has shown itself to be highly
treatment resistant and challenged further by severely limited treatment options
and clinical trials that could expand and discover new, efficacious therapies,"
said Stanislaw R. Burzynski, M.D., Ph.D. "The SPA agreement puts antineoplaston
therapy further down a straight path to regulatory approval, enabling the kind
of study that should prove its merits as another option to cancer management."

"BRI has reached this important milestone independently without financial
backing from the government, and without a major pharmaceutical partner-a unique
accomplishment in the oncology field. From inception, we have been committed to
developing a targeted gene therapy option that is less aggressive on the body
than conventional therapies and have made considerable progress on the steps
mandated by the FDA to bring a new drug to a patient community and cancer type
that has unmet needs."

About the Phase III study

The primary objective of this randomized study is to compare overall survival of
children with newly-diagnosed diffuse intrinsic brainstem glioma (DBSG) who
receive combination antineoplaston therapy [Antineoplastons A10 (Atengenal) and
AS2-1 (Astugenal)] plus radiation therapy (RT) versus RT alone.

DBSG are considered to be one of the most difficult types of cancer to treat. It
combines highly malignant characteristics with the very difficult location of
the brainstem. DBSG are inoperable because they involve most of the brainstem
(diffuse and intrinsic). The number of children in the U.S. with brainstem
gliomas is approximately 660. Absent treatment, the survival rate from time of
diagnosis is six months or less.

At present, there are no standard curative treatments for the disease. RT is the
only treatment that may slow its progress, but at two years 93% of children with
this type of cancer die, and none of them survive for five years. Other
conventional treatments such as chemotherapy have generally been tried in
clinical trials but are shown to be ineffective. There are no pharmacological
treatments approved for DBSG at this time.

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.

Media:
Burzynski Research Institute, Inc.
Darlene Hodge, 713-335-5636
Darlene@burzynskiclinic.com
or
Carolyn Powers, 713-335-5664
Carolyn@burzynskiclinic.com
or
Amanda Cheslock, 212-446-1884
acheslock@sloanepr.com

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