TORONTO, May 9 /PRNewswire-FirstCall/ - Bradmer Pharmaceuticals Inc., a clinical oncology company specializing in the development and commercialization of cancer therapies, today announced its 2008 first quarter operational and financial results.
During the three months ended March 31, 2008, 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
- Prepared and submitted the Company's drug manufacturing data package
to the FDA. 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 III trial.
- Entered formal contracting and approval processes with more than 30
U.S. clinical trial sites, in line with previously stated site
- Appointed Robert Tessarolo, Vice-President Sales & Marketing, Biovail
Pharmaceuticals Canada to the Board of Directors
- Hired Jukka Karjalainen, M.D., Ph.D. as Chief Operating and Medical
"We have made significant progress toward the start of our planned
multi-center Phase III trial of Neuradiab in patients with glioblastoma.
Our submission to the FDA focuses specifically on reducing risk in the
critical areas of manufacturing, regulatory and clinical operations," said
Alan M. Ezrin, Ph.D., President and Chief Executive Officer of Bradmer. "We
have successfully completed all aspects of workup required to start this
trial and await the review of the FDA. We look forward to enrolling
|SOURCE Bradmer Pharmaceuticals Inc.|
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