Antineoplastons
Antineoplastons A10 and AS2-1 for the Treatment of Brainstem Glioma
BRI currently intends to focus its efforts on the clinical development of its Antineoplastons A10 and AS2-1 for the treatment of brainstem glioma, which is the indication for which it received “orphan drug designation” from the FDA. BRI anticipates commencing Phase III trials during 2009, which will involve the treatment of newly diagnosed children with inoperable brainstem glioma.
Phase 2 Clinical Trials
BRI began Phase II clinical trials in 1994 with four studies. Currently, BRI sponsors 19 ongoing Phase II clinical trials, which are conducted pursuant to investigational new drug applications (INDs) filed with the FDA and approved by an Institutional Review Board (IRB) designed according to federal regulations. Most of the trials involve the use of intravenous formulations of ANP; however, two trials use oral formulations. Dr. Burzynski acts as principal investigator for all clinical trials. Prior to approving a New Drug Application (NDA), the FDA requires that drug safety and efficacy be demonstrated in well-controlled clinical trials. The ultimate goal of all treatment for cancer is patient survival. However, the FDA has determined that requiring exhaustive data showing improved patient survival may unnecessarily delay the approval of new cancer drugs. For that reason, the FDA may grant marketing approval for a new drug product on the basis of adequate and well-controlled clinical trials establishing that the drug has an effect on a surrogate endpoint (milestone) that is reasonably likely to predict clinical benefit. Each of BRI’s Phase II trials describes such milestones which are used to determine success or failure of the treatment employed. In most of the trials, the milestones are radiographic evidence of tumor shrinkage by x-ray, computer aided tomography (CT) or magnetic resonance imaging (MRI). Where tumor size is used as the milestone, each clinical trial protocol describes a complete response (CR) as the complete disappearance of all tumors with no reoccurrence of tumor for at least four weeks. A partial response (PR) is described as at least a 50% reduction in total tumor size, with such reduction lasting at least four weeks. Stable disease (SD) is described as less than 50% reduction in tumor size, but no more than 50% increase in size of the tumor mass, lasting for at least 12 weeks. In 2008, twelve of the prospective clinical trials reached a milestone. Unfortunately, there can be no assurance that the results of any of these trials can be repeated, or that the other clinical trials will result in the same or similar responses.
Notwithstanding the response results of the trials that have reached a milestone, BRI management believes it is likely that the FDA may require additional clinical trials based upon such protocols to be conducted by an institution not affiliated with BRI.
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