Bradmer reports progression free survival data from previous Phase II glioblastoma multifo...( - PFS data from Neuradiab(TM) com...),Health

- PFS data from Neuradiab(TM) compares favorably to data from other

technologies -

TSX: BMR

TORONTO, July 17 /PRNewswire-FirstCall/ - Bradmer Pharmaceuticals Inc. (TSX: BMR), a biopharmaceutical company dedicated to the development and commercialization of cancer therapies, today released progression free survival (PFS) data from two previously conducted Phase II trials of Neuradiab(TM) in glioblastoma multiforme (GBM) patients. As an exploratory endpoint of the single arm Phase II trials, the data showed a mean overall PFS of 17.2 months in 19 GBM patients treated with Neuradiab. Bradmer is currently conducting a Phase III clinical trial, termed the GLASS-ART Trial, evaluating Neuradiab as an adjunct therapy to the current standard of care for GBM patients. The primary endpoint of the GLASS-ART Trial is the increase in median overall survival in the treated arm compared to the standard of care control arm.

"These PFS data from the Phase II Neuradiab trials exceed the results achieved in any other clinical trial in newly-diagnosed GBM to our knowledge. This is compelling because of recent inquiries from the U.S. Food and Drug Administration (FDA) which suggested that Bradmer may opt to evaluate sensitivities around the merits and use of PFS as an additional interim marker of prognostic benefit," said Dr. Alan M. Ezrin, President and Chief Executive Officer of Bradmer. "While the GLASS-ART Trial is being conducted with a clear primary endpoint of median overall survival, the opportunity for Neuradiab to demonstrate a patient benefit via the parameter of PFS could provide an augmented regulatory approval path. We have examined the PFS outcomes from the previous studies of Neuradiab and intend to discuss with the FDA the most appropriate method in which to use PFS data from the GLASS-ART Trial."

Recent communications from the FDA have led Bradmer to consider using PFS data not only as a secondary endpoint in the GLASS-ART Trial
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