The Burzynski Research Institute, Inc. (BRI) has announced it has partnered with Premier Research, a global clinical research services provider, to initiate and manage a pivotal Phase III clinical trial of combination antineoplastons therapy (ANP) plus radiation therapy in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma. Premier Research is currently conducting a feasibility assessment. A number of academic centers in the U.S. and Europe will be considered, including Houston-based academic centers specializing in the treatment of pediatric brain tumors. To date, Premier has secured interest and commitment from a number of sites selected. Upon completion of this assessment, a randomized, international Phase III study will commence. The study's objective is to compare overall survival of children with newly-diagnosed, diffuse, intrinsic brainstem glioma (DBSG) who receive combination antineoplastons therapy (Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal)) plus radiation therapy (RT) versus RT alone. Antineoplastons therapy (ANP) uses a synthetic version of naturally occurring peptides and amino acid derivatives found in the human body to target and control cancer cells without destroying normal cells. BRI recently announced that it had reached an agreement with the U.S. Food & Drug Administration (FDA) enabling it to move forward with a Phase III study. The agreement was made under the FDA's Special Protocol Assessment (SPA) procedure and means that the design and planned analysis of the study is acceptable to support a regulatory submission seeking new drug approval. "With the feasibility study underway we continue to move forward in accordance with our clinical development plan to bring antineoplastons therapy to market for the treatment of a disease with such a poor prognosis," said Stanislaw R. Burzynski, M.D., Ph.D. "In tandem with the commencement of this pivotal study, we remain engaged in numerous Phase II studies for other malignancies and tumor types and feel very encouraged by the building body of evidence for antineoplastons therapy."
Burzynski Research Institute Partners with Premier Research to Manage Phase III Clinical Study
News Feb 04, 2009