TORONTO, Oct. 15 /CNW/ - 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
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. (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
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
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.
For further information:
For further information: Bradmer Pharmaceuticals Inc., Mr. Brian
Brohman, Chief Business Officer, Phone: (416) 361-6058 (Ext. 804), E-mail:
firstname.lastname@example.org, Internet: www.bradmerpharma.com; Investor
Relations, Ross Marshall, The Equicom Group Inc., Phone: (416) 815-0700 (Ext.
238), Fax: (416) 815-0080, E-mail: email@example.com