We are gratified and excited by the announcement this week that the Food and Drug Administration (FDA) has reached an agreement with the Burzynski Research Institute, Inc., for the design of a phase III trial of antineoplaston therapy for the treatment of diffuse intrinsic brainstem glioma, a rare but highly aggressive form of childhood brain cancer. This agreement effectively clears the way for the initiation of this important clinical trial. Stanislaw R. Burzynski, MD, who discovered antineoplastons and now heads the Burzynski Research Institute, has dedicated his life to the pursuit of less invasive means of cancer treatment. The announcement of the Institute’s agreement with the FDA marks a professional and personal triumph for Dr. Burzynski.
The following is the text of a press release sent out last week by the Burzynski Research Institute, announcing the agreement:
The Burzynski Research Institute, Inc. (BRI) announced that it has reached an agreement with the U.S. Food and Drug Administration (FDA) that enables the company to move forward immediately with a pivotal Phase III clinical trial of combination antineoplaston therapy plus radiation therapy in patients with newly-diagnosed, diffuse, intrinsic brainstem glioma. Antineoplaston 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. The agreement was made under the FDA's Special Protocol Assessment (SPA) procedure and means that the design and planned analysis of the Phase III study is acceptable to support a regulatory submission seeking new drug approval.
"We are very pleased by our agreement with the FDA to move forward with a confirmatory study on a type of tumor that has shown itself to be highly treatment resistant and challenged further by severely limited treatment options and clinical trials that could expand and discover new, efficacious therapies," said Stanislaw R. Burzynski, M.D., Ph.D. "The SPA agreement puts antineoplaston therapy further down a straight path to regulatory approval, enabling the kind of study that should prove its merits as another option to cancer management."
"BRI has reached this important milestone independently without financial backing from the government, and without a major pharmaceutical partner-a unique accomplishment in the oncology field. From inception, we have been committed to developing a targeted gene therapy option that is less aggressive on the body than conventional therapies and have made considerable progress on the steps mandated by the FDA to bring a new drug to a patient community and cancer type that has unmet needs."
About the Phase III study
The primary objective of this randomized study is to compare overall survival of children with newly-diagnosed diffuse intrinsic brainstem glioma (DBSG) who receive combination antineoplaston therapy [Antineoplastons A10 (Atengenal) and AS2-1 (Astugenal)] plus radiation therapy (RT) versus RT alone.
"DBSG are considered to be one of the most difficult types of cancer to treat. It combines highly malignant characteristics with the very difficult location of the brainstem. DBSG are inoperable because they involve most of the brainstem (diffuse and intrinsic). The number of children in the U.S. with brainstem gliomas is approximately 660. Absent treatment, the survival rate from time of diagnosis is six months or less.
At present, there are no standard curative treatments for the disease. RT is the only treatment that may slow its progress, but at two years 93% of children with this type of cancer die, and none of them survive for five years. Other conventional treatments such as chemotherapy have generally been tried in clinical trials but are shown to be ineffective. There are no pharmacological treatments approved for DBSG at this time. PHONE CONSULTATIONS
A phone consultation with Dr. Ralph Moss can help you to evaluate the available treatment options. As one recent phone consultation client put it:
"For some months I have been looking for advice on possible further treatments given that I have progressed through first and second line chemotherapy treatments fairly successfully and will finish radiation treatment soon. The question I faced was rather simple, now what? I needed a competent professional to provide me with suggestions for further treatment so I turned to Dr. Moss who appeared as the most knowledgeable person I could find anywhere on the internet. The choice turned out to be a good one. During a one hour session Dr. Moss as a caring, empathetic professional provided both my wife and I with several well evaluated further treatments for me to investigate. I am grateful for our session together and look forward to following up on the suggestions of Dr. Moss and communicating with him about those suggestions." - Dr. W. C., December 2008
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