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Thought Leaders from Burzynski Research Institute, Inc. Present Encouraging Data on Antineoplastons for Treatment of Malignant Gliomas

Thu. November 20, 2008; Posted: 09:27 AM
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HOUSTON & LAS VEGAS, Nov 20, 2008 (BUSINESS WIRE) -- BZYR | Quote | Chart | News | PowerRating -- Several thought leaders from the Burzynski Research Institute, Inc. (BRI) and the Burzynski Clinic (BC) in Houston, Texas are presenting at the 13th Annual Scientific Meeting of the Society for NeuroOncology. Held in Las Vegas, the international meeting convenes physicians and academia to share knowledge, discuss and advance the treatment of brain tumors. The content presented by BRI is significant as it adds to an expanding body of evidence that suggests certain malignant gliomas to be responsive to antineoplaston therapy.

"The early clinical data associated with antineoplastons are promising for patients affected by certain malignant gliomas whose options historically have been limited to conventional chemotherapy and radiation therapy for management of their disease," said Stanislaw R. Burzynski, M.D., Ph.D. "We are encouraged by the growing body of evidence and excitement around ANP as we continue our commitment to introducing less aggressive, efficacious cancer treatment options."

Leading the discussions from BRI and the clinic are Robert Weaver, M.D., Barbara Burzynski, M.D., Gregory S. Burzynski, M.D., Barbara Szymkowski, M.D., Sonali Patil, Ph.D., and Stanislaw R. Burzynski, M.D., Ph.D.

On Friday, November 21st, the group will present "Phase II study of Antineoplastons A10 and AS2-1 (ANP) in Patients with Newly-Diagnosed Anaplastic Astrocytoma: A preliminary Report."

In this Phase II clinical trial, ANP is administered daily on an outpatient basis, via an ambulatory infusion pump, to adult patients with newly-diagnosed anaplastic astrocytoma (AA), a common type of malignant glioma. The prognosis for patients with AA is usually poor with five-year's survival in less than 30% of patients, even after surgery, chemotherapy and radiation therapy.

The report being presented summarizes the treatment of a group of 20 evaluable patients, none of whom received radiation or chemotherapy prior to starting ANP. Six patients underwent surgery and had residual tumor; and 14 patients had biopsy only. ANP was well tolerated, with just two cases of serious reversible toxicities. Complete disappearance of tumors was achieved in 25% of patients, 40% of patients had stabilization of disease, and 35% of patients failed ANP treatment. Preliminary results indicate that satisfactory percentage of objective response to ANP was achieved.

On Saturday, November22nd BRI will reveal findings on "Antineoplaston AS2-1 Affects Cell Cycle Checkpoints, Leading to Apoptosis in Human Glioblastoma Cells."

Antineoplastons are naturally occurring peptides and amino acid derivatives currently being used with positive results in Phase II clinical trials for treatment of several brain tumor types. Phenylaceate (PN) and phenylacetylglutaminate (PG) are two major components of anti-neoplaston AS2-1 (AS) and are metabolites of phenylbutyrate (PB). Though PN has been well studied, the mechanism of action for PG is not well understood. PN has been reported to cause G1 arrest in several tumor cell lines. This study reports that PG also exerts its effect as an anti-prolfierative agent by similar mechanism and provides evidence that PG causes G1 blockade and apoptosis. The effect is enhanced when PG and PN are used in combination, as in AS. Based on pathway analysis, it was observed that antineoplastons affected the expression of more than 40 genes instrumental in the cell cycle in glioblastoma cells. Antineoplastons may target multiple levels in the cell cycle and enhance the anti-cancer effect of tumor suppressor genes.

Abstracts were published in the October 2008 issue of Neuro-Oncology, the official journal of the Society of Neuro-Oncology.

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 19 Phase II clinical trials, some of which are coming now to a successful conclusion. Since antineoplastons effect approximately 100 genes instrumental in the growth of glioblastoma multiforme, the results of research will be presented in a number of neuro-oncology meetings and published as abstracts in Neuro-Oncology. Earlier this year BRI and the BC team presented at the 13th International Symposium of Pediatric Neuro-Oncology in Chicago, Illinois (June 29-July 2, 2008), a successful preliminary report on the Phase II study of antineoplastons A10 and AS2-1 in children with optic pathway glioma. At the September 2008 annual meeting of the European Association for Neuro-Oncology in Barcelona, Spain, BRI presented two reports. In one of them, it was described how the ingredients of ANP down-regulate glycolysis pathways in glioblastoma cells. The second report described preliminary successful results of Phase II study of ANP in patients with recurrent anaplastic astrocytoma.

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. BRI does not undertake to update any such forward- looking statements or to publicly announce developments or events relating to the matters described herein.

SOURCE: Burzynski Research Institute, Inc.

Media: Burzynski Research Institute, Inc. Darlene Hodge, 713-335-5636 Darlene@burzynskiclinic.com or Carolyn Powers, 713-335-5664 Carolyn@burzynskiclinic.com or Amanda Cheslock, 212-446-1884 acheslock@sloanepr.com

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