|By PR Newswire||
|January 8, 2014 12:35 PM EST||
HOUSTON, Jan. 8, 2014 /PRNewswire/ -- The Burzynski Clinic (BC) announced today the preliminary response to the allegations in the lawsuit filed by Texas Medical Board (TMB) at the Texas State Office of Administrative Hearing on December 11, 2013 against Stanislaw R. Burzynski, M.D., Ph.D. (SRB). The allegations claim that SRB used internet-based advertising regarding antineoplastons (ANP), and that it was false, misleading, and violated federal law. The allegations can be divided into concerning preclinical and clinical research. The TMB claims that the terms used by SRB for the description of the mechanism of action of ANP, such as, molecular switches that cause the death of cancer cells, but do not inhibit normal cells and that ANP are multitargeted agents, are false and misleading. These terms were introduced in numerous publications in peer-reviewed journals and presentations at medical meetings by SRB and outside researchers, and represent findings of medical research permitted by Federal Law.
In the area of clinical research, the TMB claims the false statement that ANP treatment is limited to patients who cannot be helped by other treatments and have the worst type of cancer. This true statement is derived from FDA supervised protocols, which restrict ANP to only such cases. The TMB further claims that the information that 50% of children under 3 years survive over 5 years and that the clinic has patients who survived over 20 years without any sign of cancer, is false. These statements are true and supported by data coming from clinical trials which were published in peer-reviewed journals and presented at medical meetings. In fact, the percentage of survival at 5 years of children in this age group is 57% and currently there are 11 patients diagnosed with incurable cancer who are surviving over 20 years as a result of treatment with ANP. The disputed statements were also used in continuous medical education for physicians, accredited by the American Medical Association.
Finally, the TMB alleges that it was inappropriate to provide the link to the interview by public TV of the researcher who was not employed by BC and who stated that ANP can help cure cancer and that ANP is a highly effective anticancer medicine. The cure of cancer is the term frequently used by the American Cancer Society for patients diagnosed with early stages. It is generally defined as survival for over five years from the time of diagnosis. BC routinely publishes and presents at medical meetings the data regarding over five year survival of the types of cancers which cannot be cured by standard treatment. In fact, according to these presentations, 77 eligible patients in brain tumor trials survived over five years from the treatment start. It is the opinion of the legal counsels of BC that these allegations are frivolous and that they will be the subject of vigorous legal defense.
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 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 the clinic's ability to use personalized targeted cancer therapy. Burzynski Clinic 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 Clinic