Burzynski Clinic Presents the Results of a Phase II Study of Antineoplastons in Pediatric Recurrent Diffuse Intrinsic Pontine Glioma at the Congress
HOUSTON, Nov. 26, 2013 /PRNewswire/ — The Burzynski Clinic (BC) announced today that it made a presentation of the results of a phase II study of antineoplastons A10 and AS2-1 (ANP) in pediatric recurrent diffuse intrinsic pontine glioma (DIPG) at the 4(th) Quadrennial Meeting of the World Federation of Neuro-Oncology in San Francisco. Brainstem gliomas are rare tumors in which DIPG comprises a distinct group. Numerous trials have been conducted in DIPG without proving pharmacological benefit. This report, presented at the poster session, is focused on the results of treatment of 17 pediatric patients diagnosed with recurrent DIPG. The median age in this group was 8.8 years old. Previous treatment included radiation therapy, chemotherapy, and surgery (in 2 patients). At least 8 weeks elapsed from the initiating of ANP and the previous radiation therapy and 6 weeks elapsed between initiating ANP and the previous chemotherapy. ANP was administered intravenously and the median duration of treatment was 5.6 months. Responses were assessed by magnetic resonance imaging (MRI). In this group of patients, complete and partial responses were documented in 29.5% and stable disease in 23.5%. One year overall survival was 29.4%, two years was 11.8%, and five, 10, and 15 years was 5.9%. One patient is surviving for over 15 years from the treatment start. Grade 4 toxicities including hypokalemia and fatigue occurred in 6% and hypernatremia in 18% of patients. Grade 3 fatigue, somnolence, skin allergy, and urinary incontinence occurred in 6 to 12% of patients. There were no chronic adverse events. Responding patients experienced an improved quality of life.
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