Metastatic Colon Cancer: In a Randomized Phase II Clinical Study, Antineoplaston Therapy Doubled the 5-Year Survival Rate Fol...
May 27 2009 - 7:00AM
Business Wire
The Burzynski Research Institute, Inc. (BRI) is pleased to
announce the results of a randomized Phase II clinical study of
antineoplaston therapy (ANP therapy) in metastatic colon cancer
following curative resection of hepatic metastases. The study was
performed at the Kurume University School of Medicine (Japan) in
the Department of Surgery. A report of the study results is
currently in press.
The study population consisted of 65 colon cancer patients who
had undergone curative resection of hepatic metastases and were
randomized to 1) intrahepatic infusion of 5-FU (33 patients), or 2)
intrahepatic infusion of 5-FU plus IV ANP therapy (32 patients).
ANP therapy consisted of a) 50-100 g IV infusion of Antineoplaston
A10 given daily for seven days following hepatic resection and b)
10 g of oral Antineoplaston AS2-1 given daily for one year. There
was a significant difference in overall survival between the two
groups: with the five-year survival rate in the 5-FU plus ANP
therapy arm being 62% versus 32% in the 5FU-only arm. The mode of
recurrence was also different in the two study arms. In the
5FU-only arm, recurrences affected multiple organs in 69%, while in
the 5-FU plus ANP therapy arm, recurrences affected multiple organs
in only 34%, which provided for a higher complete second resection
rate in the 5-FU plus ANP therapy arm (61% versus 35%).
Dr. Stanislaw R. Burzynski, Chairman and CEO of BRI, stated, �We
are very pleased with the results of this study, and thankful to
our Japanese colleagues. The results indicate that ANP therapy may
find application not only in the treatment of brain tumors as
reported previously, but also in the more common colorectal
cancer.�
Kurume University is among the oldest and most successful
medical universities in Japan. Its Department of Surgery has a
strong interest in the development of successful treatments for
colorectal and liver cancers.
Burzynski Research Institute, Inc. (BRI) is a biopharmaceutical
company committed to developing treatment for cancer based on
genomic and epigenomic principles. Research and development efforts
are now focused on basic research and Phase III 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.
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