TORONTO, Oct. 15 /PRNewswire-FirstCall/ - Bradmer Pharmaceuticals Inc., abiopharmaceutical company dedicated to the development and commercializationof cancer therapies, today announced that it held a pre-Phase III meeting withthe U.S. Food and Drug Administration (FDA) at which the FDA concurred withBradmer's proposed design of the Phase III trial for its lead drug, Neuradiab,a treatment for newly diagnosed glioblastoma multiforme (GBM), the most commonform of brain cancer.
At the recent meeting, the FDA responded favorably to the Company'spresentation 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 theappropriate clinical structure of a multicenter trial that would be suitablefor the potential registration of Neuradiab," commented Alan M. Ezrin, Ph.D.,President and Chief Executive Officer of Bradmer. "We are delighted with theFDA's response to the presentation of our clinical plans, which were developedin conjunction with the FDA, with our collaborators at Duke University andwith thought leaders in neurooncology and neurosurgery."
Bradmer and the FDA discussed and agreed to the study trial design whichincludes an enhanced statistical power calculation of 90% and an added interimefficacy analysis. The agreed design, which will allow for the enrollment ofapproximately 380 patients in each of the experimental and control arms, hasthe possibility to actually shorten the study trial duration and to improvethe statistical probability of success. Bradmer anticipates a 24-monthenrollment period and an interim efficacy analysis on overall survival atapproximately month 39 post-trial initiation, or at 470 mortality events.Should an additional efficacy analysis be required, it would occur at 626events.
Prior to the initiation of the trial, the Company must present a completechemistry, manufacturing and controls (CMC) update to the FDA for its reviewand approval. To facilitate this, Bradmer has submitted a request for anadditional guidance meeting with the FDA, during which the Company will detailthe technology transfer of the production of Neuradiab from the previousmanufacturer to a cGMP commercial facility. Management anticipates that therequested CMC meeting will occur in the near future and the enrollment ofpatients could begin in late 2007 or in early 2008.
About Bradmer Pharmaceuticals Inc. (www.bradmerpharma.com)
Bradmer Pharmaceuticals is a biopharmaceutical company focused on thedevelopment and commercialization of new and innovative cancer therapies.Bradmer's lead clinical candidate, Neuradiab, was developed at Duke UniversityMedical Center as a proprietary therapy for a particularly aggressive form ofbrain cancer, glioblastoma multiforme. To date, over US$60 million in grantsand related support has driven research and development of the licensedtreatment, which has been delivered to over 200 patients with promisingresults and has completed Phase II clinical trials at Duke University. Bradmeris currently in the process of organizing a prospective multi-center clinicaltrial of the licensed treatment. Neuradiab has been granted Orphan Drug Statusby both the U.S. Food and Drug Administration and the European MedicinesAgency.
Bradmer Pharmaceuticals Inc.'s common shares have not been registeredunder the Securities Act of 1933, as amended (the "Securities Act") or anystate 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 tothe requirements of Rule 904 of Regulation S of the Securities Act or suchother applicable exemption thereunder, and other applicable state securitieslaws.
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