Metastatic Colon Cancer: In a Randomized Phase II Clinical Study, Antineoplaston Therapy Doubled the 5-Year Survival Rate Following Curative Resection of Hepatic Metastases
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.
Posted: May 2009
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