TSX: BMR
TORONTO, March 31 /PRNewswire-FirstCall/ - Bradmer Pharmaceuticals Inc. ("Bradmer" or the "Corporation") announced its 2008 fourth quarter and fiscal year operational and financial results.
Operational Highlights
During the year ended December 31, 2008, the Company achieved the following steps for its multi-center Phase III trial of its lead drug Neuradiab(R), a treatment for glioblastoma multiforme (GBM), the most advanced form of brain cancer:
- Prepared and submitted the Company's drug manufacturing data package
and clinical dossiers to the FDA;
- Initiated enrollment in the Phase III GLASS-ART clinical trial;
- Signed contracts with and activated an initial cohort of five U.S.
clinical trial sites;
- Successfully released a second GMP drug substance batch for use in
clinical trials and filed the related update with the FDA;
- Submitted new data from the previous Phase II trial indicating that
the mean time to progression free survival was 77 weeks, which
compares favorably with other published results in newly diagnosed
GBM (Reardon et al.; 2008 Neuro-Oncology 10:845); and
- Sourced and validated commercial supplies of iodine-131 outside of
the U.S. and Europe to prevent delays in raw material supply.
Subsequent to the financial year ended December 31, 2008, the Company commenced a strategic review of its operations, as more particularly described in press releases of the Company dated February 17, 2009 and March 5, 2009. Pursuant to the strategic review, the Company has closed its Phase III GLASS ART Trial to further patient enrollment due to unforeseen delays in site initiation and recruitment, the delayed ability to complete the 60 patient "run-in phase" in a timely manner, and the inability to raise further capital at this time.
The Company
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