FDA Approves New Use of Xifaxan for Patients with Liver Disease

The U.S. Food and Drug Administration today approved the use of Xifaxan for reduction in the risk of the recurrence of overt hepatic encephalopathy (HE) in patients with advanced liver disease. This is a new use for Xifaxan (rifaximin), a drug that has been approved for the treatment of traveler’s diarrhea.

Hepatic encephalopathy is a worsening of brain function that can occur in patients whose liver can no longer remove toxins from the blood. Increased levels of ammonia in the blood are thought to play a role in the development of HE, and Xifaxan works by reducing these levels.

“The approval of Xifaxan for this new indication provides an additional treatment option for patients with liver disease,” said Joyce Korvick, M.D., deputy director for safety of FDA’s Division of Gastroenterology Products. “Hepatic encephalopathy occurs commonly in patients with liver disease, and there are few effective treatments for this serious condition.”

The efficacy of Xifaxan was established in a randomized placebo-controlled clinical trial of adult patients from the United States, Canada, and Russia. Patients with liver disease who entered the trial had no or mild symptoms of HE. Patients treated with Xifaxan were less likely to develop HE during the trial, compared to placebo-treated patients.

Xifaxan was not studied in patients with the most severe forms of liver disease. Since most patients were also taking lactulose (a synthetic sugar which helps prevent absorption of ammonia from the intestine) during the trial, the efficacy of Xifaxan as a stand-alone treatment for HE could not be assessed.

The most common adverse reactions reported with the use of Xifaxan in patients with liver disease include swelling of the arms and legs (peripheral edema), nausea, gas, and headache.

Xifaxan received a priority review under FDA’s new drug application process and was granted orphan designation status. Xifaxan is manufactured by Salix Pharmaceuticals Inc. of Morrisville, N.C.

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Metastatic Colon Cancer: In a Randomized Phase II Clinical Study, Antineoplaston Therapy Doubled 5-Yr Survival Rate‏

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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