Burzynski Research Institute Announces Favorable Objective Response Rates And Overall Survival In Adults With Anaplastic Astrocytoma Following Antineoplastons A-10 And AS2-1

HOUSTON--(BUSINESS WIRE)--Burzynski Research Institute, Inc. (BRI) announced today the publication of “A Phase II Study of Antineoplastons A10 and AS2-1 (ANP) in Adult Patients with Primary Brain Tumors – Final Report (Protocol BT-09)”. This single arm, two stage, phase II clinical trial, was designed to treat adults with different types of primary brain tumors that were not curable by standard therapy. Fourteen of 40 patients treated (35%) had an anaplastic glioma (AG), of which 12 (86%) had an anaplastic astrocytoma (AA), a grade 3 tumor with a poor prognosis. In BT-09, the objective response rate in AA patients was 42% while the median progression-free survival was 5.4 months. The median overall survival (OS) for AA patients was 25.4 months with the OS at 6 months, 1 year, and 2 years being 83%, 58%, and 50% respectively, which compares favorably with current standard treatment. ANP was well-tolerated with reversible grade 3 and 4 toxicity in 35% of all 40 patients treated. After a review of BRI’s Investigator Brochure and annual reports, which documented outcomes for all AGs treated with ANP in phase II clinical trials, the FDA, in personal correspondence with BRI, advised an end-of-phase II meeting “for grade 3 AGs, specifically AA, anaplastic oligodendroglioma, and mixed oligoastrocytoma [OR rate of 20% (95% CI: 12, 31)]”, indicating that ANP exhibited sufficient clinical activity in these tumors to justify further development.

“A Phase II Study of Antineoplastons A10 and AS2-1 (ANP) in Adult Patients with Primary Brain Tumors – Final Report (Protocol BT-09)”

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 publicly announce developments or events relating to the matters described herein.