Re: [MOL] DR BURZINSKI/reply [03332] Medicine On Line

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May 26, 1998
Source: Business Wire

Burzynski Research Institute Announces Interim Cancer Drug Results

HOUSTON--(BUSINESS WIRE) via NewsEdge Corporation -- Burzynski Research Institute, Inc. (OTC bulletin board stock symbol:BZYR) today announced interim results from Phase II clinical trials of its experimental cancer drugs, Antineoplastons, in the treatment of brain cancer.

Used in combination, Antineoplastons A10 and AS2-1 produced responses (complete tumor elimination or greater than 50% reduction in tumor size) in 43 of 178 evaluable patients, for a response rate of 24.1 per cent. An additional 72 patients (40.5% of evaluable patients) experienced stable disease, meaning their tumors did not progress, or shrink more than 50%.

The two largest groups of patients suffered from glioblastoma multiforme (36.5%) and astrocytoma-type tumors (32%). Approximately 10% of patients had difficult-to-treat brain stem tumor locations.

"These results are exciting because conventional treatments are generally considered ineffective against primary malignant brain tumors," said Stanislaw Burzynski MD, PhD, the firm's founder and CEO. "What makes it all the more exciting is that these are responses in human brain cancers that are normally considered incurable and fatal. The patients with stable disease give us hope that even the most intractable cancers may become manageable chronic diseases."

The drugs represent a type of gene therapy that targets the signal path of errant ras oncogenes and the p53 tumor suppressor gene. Malfunctions in these genes are believed responsible for up to 60% of all human cancers.

"The drugs function as chemical microswitches, turning off the signal that makes cancer cells multiply endlessly, at the same time turning on the signal that tells the cells to undergo programmed cell death, or apoptosis," Burzynski said. "This is an information-age approach to cancer treatment because it uses information, rather than energy, to do the job."

Antineoplastons were well-tolerated by most patients. The most commonly reported adverse event was an elevated level of serum sodium. 1.3% of all clinical trial patients had elevations of 180 mEq/L or higher at or around the time of their deaths. Other adverse events included nausea, vomiting, allergic skin reactions, joint and muscle pain, and fatigue, and occurred in a small percentage of patients.

Burzynski believes the company now has enough data to apply for FDA approval. An NDA (New Drug Application) could be filed by the end of this year.

CONTACT: Burzynski Research Institute Inc., Houston | Dr. Stanislaw Burzynski, 281/597-0111 | | | or | Dean Mouscher, 773/404-0486