Bradmer provides Phase III Neuradiab trial update an... ( TSX...)

Bradmer provides Phase III Neuradiab trial update and guidance

Date:10/15/2007

TSX: BMR

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.

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