TORONTO, March 12 /PRNewswire-FirstCall/ - Bradmer Pharmaceuticals Inc., a clinical oncology company specializing in the development and commercialization of cancer therapies, today announced its 2007 fourth quarter and fiscal year operational and financial results.
During the year ended December 31, 2007, the Company achieved the
following steps in preparation for the upcoming multi-center Phase III
trial and subsequent planned commercialization for its lead drug Neuradiab,
a treatment for glioblastoma multiforme, the most deadly form of brain
- Completed development and validation of cGMP manufacturing processes
of the Neuradiab drug substance (antibody component) and final drug
product (radiolabeled antibody).
- Conducted pre-Phase III meetings with the U.S. Food and Drug
Administration (FDA) regarding the protocol and design of the Phase
III trial as well as the drug manufacturing processes.
- Entered formal contracting and approval processes with more than 30
U.S. clinical trial sites, in line with previously stated site
- Prepared and submitted the Company's drug manufacturing data package
to the FDA, subsequent to the end of the fiscal year. The submission
is currently under review. After completion of the review and
satisfactory resolution of any further requests of the FDA, if any,
Bradmer will submit a clinical update to its Investigational New Drug
(IND) application and proceed with the launch of the planned Phase
"We have made significant progress toward the initiation of our planned
multi-center Phase III trial of Neuradiab by focusing specifically on
reducing risk in the critical areas of manufacturing, regulatory and
clinical operations," said Alan M. Ezrin, Ph.D
|SOURCE Bradmer Pharmaceuticals Inc.|
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