Burzynski Clinic Presents the Results of Phase II Study of Antineoplastons in Children with Recurrent High-Grade Glioma at the Congress
HOUSTON, Nov. 26, 2013 /PRNewswire/ — The Burzynski Clinic (BC) announced today that it has presented the results of a phase II study of antineoplastons A10 and AS2-1 (ANP) in children with recurrent high-grade glioma at the 4(th) Quadrennial Meeting of the World Federation of Neuro-Oncology in San Francisco. There are no standard treatment recommendations for children with high-grade glioma after recurrence. New therapies are required for patients whose tumor recurs after first-line treatment. Based on the poster presentation, this single-arm, two-stage, interventional phase II study evaluated the efficacy and safety of ANP in children with recurrent high-grade glioma. All patients had failed standard therapy, including surgery, radiation, and chemotherapy. 12 patients with a median age of 9.7 years, who met eligibility criteria were evaluated. Half of the patients were diagnosed with glioblastoma, 42% with anaplastic astrocytoma, and 1 with rhabdoid tumor. At least 8 weeks elapsed between the initiation of ANP and previous radiation and 6 weeks elapsed between the initiation of ANP and previous chemotherapy with nitrosoureas. ANP were administered intravenously and the median duration of treatment was 32 weeks. Responses were assessed by gadolinium-enhanced magnetic resonance imaging (MRI). A complete and partial response was documented in 33% and stable disease in 25% of cases. The overall survival at 1 year was 46%. 1 patient is alive 8 years post-treatment. All grade 3 and 4 toxicities (2 hypernatremias and 1 decrease of neutrophils) were reversible and there were no chronic toxicities.
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