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news.The Burzynski Research Institute, a biopharmaceutical company, has partnered with Premier Research, a provider of clinical research services, to initiate and manage a pivotal Phase III clinical trial of combination antineoplaston therapy plus radiation therapy in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma.
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Premier Research is currently conducting a feasibility assessment. A number of academic centers in the US and Europe will be considered, including Houston-based academic centers specializing in the treatment of pediatric brain tumors. 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 brain stem glioma (DBSG) who receive combination antineoplaston therapy [Antineoplastons A10 (atengenal) and AS2-1 (astugenal)] plus radiation therapy (RT) versus RT alone.
Antineoplaston therapy 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.
Stanislaw Burzynski, president of Burzynski Research Institute (BRI), said: 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 antineoplaston therapy.