Bradmer reports progression free survival data from previous Phase II glioblastoma multiforme trials
Bradmer Pharmaceuticals Inc. 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 but to evaluate such data in a blinded and centrally reviewed manner in order to be able to use the PFS data for additional labeling consideration. As the trial is currently designed, PFS data is being collected as an exploratory secondary endpoint. New regulatory submissions can include secondary endpoint data to support labeling claims for registration purposes if the data are collected in an acceptable manner. In some cases, secondary endpoint data can also provide early insight into patient benefit from an ongoing Phase III trial.
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