Burzynski Research Institute, Inc. Announces the Launch of a New Clinical Trial in Diffuse Intrinsic Brainstem Glioma

HOUSTON–(BUSINESS WIRE)–Burzynski Research Institute, Inc. (BRI) announced today that it has
begun patient enrollment into an FDA-reviewed and IRB-approved,
open-label, single-arm phase 2 study of Antineoplastons A10 and AS2-1 in
patients > 3 months of age with a diffuse intrinsic brainstem glioma
(DIPG). Study subjects will be placed in one of five treatment groups
based on their age and whether or not they have received prior treatment
for DIPG. The primary study endpoint is a decrease in the size of the
tumor, either a partial response (≥ 50% decrease in the size of the
tumor) or a complete response (disappearance of the tumor).

DIPG is primarily a disease of childhood, with the majority of patients
being between 5 and 10 years of age. However, infants and adults can
also be affected. It is the most common brainstem tumor in children,
representing 75-80% of childhood brainstem tumors, and affecting an
estimated 300 children in the U.S. each year. The prognosis for children
with DIPG is significantly worse than that of other primary brainstem
tumors. The standard of care for patients with newly-diagnosed DIPG is
radiation therapy (RT), which appears to control tumor growth for a
short period of time, prolonging survival by approximately 3 months.
Within 3-8 months after completion of RT, most patients with DIPG will
show progression of their disease. No chemotherapeutic agent has ever
demonstrated a significant improvement in outcome beyond that achieved
by RT alone. An original BRI paper, “The response and survival of
children with recurrent intrinsic pontine glioma based on a phase II
study of Antineoplastons A10 and AS2-1 in patients with brainstem
glioma” was published in Child’s Nervous System
in December 2014, Volume 30, Issue 12, pages 2051-2061 (DOI

About Burzynski Research Institute, Inc.

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 research and phase 2 and 3 clinical trials, particularly in the
treatment of brain tumors and other forms of cancer.

Forward-looking statements in this release are made pursuant to the safe
harbor provisions of the federal securities laws. Information contained
in forward-looking statements is based on current expectations and is
subject to change, and further events may differ materially from those
discussed herein due to a number of factors, including, but not limited
to, risks and uncertainties related to an ability to use Antineoplastons
A10 and AS2-1. Burzynski Research Institute, Inc. does not undertake to
update any such forward-looking statements or to publicly announce
developments or events relating to the matters described herein.

Web site: http://www.burzynskiresearch.com


Burzynski Clinic
Carolyn Powers, 713-335-5664