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Burzynski Research Institute begins trial of CAM treatment in children with rare brain cancer.

The Burzynski Research Institute Inc. announced in January that 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 children newly diagnosed with a type of brainstem tumor: diffuse intrinsic brainstem glioma (DBSG).

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Premier Research is conducting a feasibility assessment. Several academic centers in the US and Europe will be considered, including Houston-based academic centers specializing in treating pediatric brain tumors. To date, Premier has secured interest and commitment from a number of sites selected. When the assessment is complete, the randomized, international phase III study will commence.

Phase III trials are conducted to verify whether a new treatment is better than standard treatment. In this case, the study's objective is to compare overall survival of children newly diagnosed with DBSG who receive combination ANP (Antineoplastons A 10 [Atengenal] and AS2-1 [Astugenal]) plus radiation therapy (RT), versus RT alone. 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.

The Burzynski Research Institute recently announced that it had reached an agreement with the US Food and 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, meaning that the design and planned analysis of the study is acceptable to support a regulatory submission seeking new-drug approval.

"With the feasibility study under way, 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 institute president Stanislaw R. Burzynski, MD, PhD. "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."

Premier Research delivers high-quality clinical trial services for biopharmaceutical and medical device companies and has a successful track record providing services for covering a wide spectrum of cancer-related therapeutic indications. Premier Research's oncology expertise ranges from small dose findings and proof-of-concept studies to large multinational phase III trials and as such is well suited to partner with BRI on this study. In addition to oncology, the company leads in the management of clinical research for analgesia, CNS, and infectious disease and has deep experience in medical device and pediatric research. Premier Research maintains a well-established network of dedicated clinical sites, with 30 offices and operations in more than 30 countries throughout North America and Europe.

Burzynski Research Institute Inc. is a biopharmaceutical company committed to developing treatment for cancer based on genomic and epigenomic principles. Research and development efforts are focused on basic ANP research and phase III clinical trials.

For further information, please contact:

Burzynski Research Institute

9432 Old Katy Road, Suite 200

Houston, Texas 77055

713-335-5636; fax: 713-935-5658

info@burzynskiclinic.com

http://www.burzynskiclinic.com
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Title Annotation:combination antineoplastons therapy
Publication:Townsend Letter
Date:Nov 1, 2009
Words:508
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