TORONTO, Oct. 15 /PRNewswire-FirstCall/ - Bradmer Pharmaceuticals Inc., a biopharmaceutical company dedicated to the development and commercialization of cancer therapies, today announced that it held a pre-Phase III meeting with the U.S. Food and Drug Administration (FDA) at which the FDA concurred with Bradmer's proposed design of the Phase III trial for its lead drug, Neuradiab, a treatment for newly diagnosed glioblastoma multiforme (GBM), the most common form of brain cancer.
At the recent meeting, the FDA responded favorably to the Company's presentation of its full clinical plan which included the trial protocol, standard operating procedures, statistical plan, and related documents.
"We initiated this discussion with the FDA to establish clarity around the appropriate clinical structure of a multicenter trial that would be suitable for the potential registration of Neuradiab," commented Alan M. Ezrin, Ph.D., President and Chief Executive Officer of Bradmer. "We are delighted with the FDA's response to the presentation of our clinical plans, which were developed in conjunction with the FDA, with our collaborators at Duke University and with thought leaders in neurooncology and neurosurgery."
Bradmer and the FDA discussed and agreed to the study trial design which includes an enhanced statistical power calculation of 90% and an added interim efficacy analysis. The agreed design, which will allow for the enrollment of approximately 380 patients in each of the experimental and control arms, has the possibility to actually shorten the study trial duration and to improve the statistical probability of success. Bradmer anticipates a 24-month enrollment period and an interim efficacy analysis on overall survival at approximately month 39 post-trial initiation, or at 470 mortality events. Should an additional efficacy analysis be required, it would occur at 626 events.
Prior to the initiation of the trial, the Company must present a complete chemistry, manufacturing and controls (CMC) update to the FDA for its review and approval. To facilitate this, Bradmer has submitted a request for an additional guidance meeting with the FDA, during which the Company will detail the technology transfer of the production of Neuradiab from the previous manufacturer to a cGMP commercial facility. Management anticipates that the requested CMC meeting will occur in the near future and the enrollment of patients could begin in late 2007 or in early 2008.
About Bradmer Pharmaceuticals Inc. (http://www.bradmerpharma.com)
Bradmer Pharmaceuticals is a biopharmaceutical company focused on the development and commercialization of new and innovative cancer therapies. Bradmer's lead clinical candidate, Neuradiab, was developed at Duke University Medical Center as a proprietary therapy for a particularly aggressive form of brain cancer, glioblastoma multiforme. To date, over US$60 million in grants and related support has driven research and development of the licensed treatment, which has been delivered to over 200 patients with promising results and has completed Phase II clinical trials at Duke University. Bradmer is currently in the process of organizing a prospective multi-center clinical trial of the licensed treatment. Neuradiab has been granted Orphan Drug Status by both the U.S. Food and Drug Administration and the European Medicines Agency.
Bradmer Pharmaceuticals Inc.'s common shares have not been registered under the Securities Act of 1933, as amended (the "Securities Act") or any state regulatory agency in the United States. The resale or transfer by a U.S. investor of such common shares of Bradmer Pharmaceuticals Inc. is subject to the requirements of Rule 904 of Regulation S of the Securities Act or such other applicable exemption thereunder, and other applicable state securities laws.
Except for historical information, this press release may contain forward-looking statements, which reflect the Company's current expectation regarding future events. These forward-looking statements involve risk and uncertainties, which may cause but are not limited to, changing market conditions, the successful and timely completion of clinical studies, the establishment of corporate alliances, the impact of competitive products and pricing, new product development, uncertainties related to the regulatory approval process and other risks detailed from time to time in the Company's ongoing quarterly and annual reporting.
|SOURCE Bradmer Pharmaceuticals Inc.|
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