Bradmer announces Phase II results published in newly diagnosed glioblastoma which demonstrate improved survival and support upcoming Phase...(th Neuradiab in which dosing is basedupo...),Health

Date:2/26/2008

th Neuradiab in which dosing is based upon the tumor burden left after surgical resection. The data suggest a marked increase in overall survival that builds on the significant body of previous work completed to date. This is the seventh clinical publication on Neuradiab in the GBM population and we look forward to the start of the multi-center trial based upon a well designed data driven approach."

The primary objective of the published Phase II trial (Study 01128) was to determine the feasibility of patient-specific dosing of Neuradiab. The article outlines the procedure that enabled each patient to receive an optimal dose of 44-Gy radiation based on the individual surgical resection and the tumor burden. The results confirm that patient-specific dosing can be readily and consistently performed. The trial also monitored overall survival from the time of Neuradiab administration to patient death. The 21 patient trial demonstrated a median overall survival of 90.6 weeks which represents an encouraging increase in survival compared to the historical control of 64 weeks in the current standard of care. The optimal dose of 44 + 10% Gy internal radiation boost to this population was designed based upon a previous meta-analysis of the Neuradiab population that had been treated at Duke allowing for an evaluation of therapeutic target dose based upon benefit/risk profiles (Akabani G, et al., J Nucl Med. 1999;40:631 - 638.). The present study confirms the standard execution of a personalized dosing that will be done in each patient between the time of surgery and initiation of standard of care therapy and also confirms the safety and benefit of the patient-specific dosing.

In preparation for its pending multi-center Phase III trial, the Company has completed the final validation phase of the manufacturing process for Neuradiab under Good Manufacturing Practices (GMP). The initial manufacturing data were reviewed with the U.S. Food and Drug Administration (FDA)
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SOURCE Bradmer Pharmaceuticals Inc. Copyright©2008 PR Newswire. All rights reserved

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