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Bradmer reports progression free survival data from previous Phase II glioblastoma multiforme trials
Date:7/17/2008

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.

A recent article published in Neuro-Oncology (Lamborn et al, 2008) examined six-month progression free survival as a predictor of overall survival in glioma patients. The article included data from 597 adult patients with recurrent high-grade gliomas that enrolled in Phase II trial protocols collected by the North American Brain Tumor Consortium between 1998 and 2002. The study concluded that progression status at 9, 18, and 26 weeks were strong predictors of survival and that progression free survival is a valid endpoint for trials of therapies for recurrent malignant glioma.

Bradmer's PFS analysis is based on 19 GBM patients in two recent single-arm Phase II trials of Neuradiab with a targeted dose of 44 Gy delivered as an adjunct to the current standard of care consisting of surgery, temozolomide and external radiation therapy (study 01128; n = 21 (Reardon et al., J Neuro-Oncology, Doc. D06-00199, February 20, 2008) (http://neuro-oncology.dukejournals.org) (DOI:10.1215/15228517-2007-053) and study 05018; n = 5).

In addition, Bradmer has reviewed the existing external GBM literature, and in nine of the eleven studies published between 2003 and 2008 by outside parties that the Company analyzed, progression free survival ranged from 4 to 10 months, with two other studies achieving 13 month and 17 month PFS results. The results from the external stu
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SOURCE Bradmer Pharmaceuticals Inc.
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