HOUSTON, Oct. 24, 2014 /PRNewswire/ -- Burzynski Research
Institute, Inc. (BRI) announced today that the U.S. Food and Drug
Administration (FDA) has given the company permission to conduct an
open-label 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). The
study is in its final organizational stage and will begin accruing
patients as soon as this organizational stage is completed.
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 Burzynski Clinic 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 with open access
at Springerlink.com on April 10, 2014
(Childs Nerv Syst DOI 10.1007/s00381-014-2401-z).
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 publically announce
developments or events relating to the matters described
herein.
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/burzynski-research-institute-inc-announces-fda-permission-to-launch-a-new-clinical-trial-in-diffuse-intrinsic-brainstem-glioma-940500516.html
SOURCE Burzynski Research Institute, Inc.