Bradmer announces Phase II results published in newly diagnosed glioblastoma which demonstrate improved survival and support upcoming Phase III study
The study, conducted at Duke University Medical Center evaluating theefficacy and toxicity of Neuradiab as an adjunct to standard of care therapyin a 21 patient trial, demonstrated a 42 percent increase in overall survivalcompared to a historical control of the current standard of care. The articletitled, "A pilot study: 131I-Antitenascin monoclonal antibody 81c6 to delivera 44-Gy resection cavity boost", written by David A. Reardon and Michael R.Zalutsky as lead authors, will be published in the April 2008 edition ofNeuro-Oncology.
"This article represents a detailed review of the results from thepatient-specific dosing protocol utilized in the Neuradiab Phase II trial. Thestudy forms the basis for the design of our multi-center Phase III trial. Weare pleased to have the results published and look forward to working with Dr.David Reardon as the principal investigator and our extensive base ofinvestigators and thought leaders as we approach the start of our multi-centertrial," said Alan M. Ezrin, Ph.D., President and Chief Executive Officer ofBradmer. "The article outlines the potential benefit of patient-specificdosing with Neuradiab in which dosing is based upon the tumor burden leftafter surgical resection. The data suggest a marked increase in overallsurvival that builds on the significant body of previous work completed todate. This is the seventh clinical publication on Neuradiab in the GBMpopulation and we look forward to the start of the multi-center trial basedupon a well designed data driven approach."
The primary objective of the published Phase II trial (Study 01128) was todetermine the feasibility of patient-specific dosing of Neuradiab. The articleoutlines the procedure that enabled each patient to receive an optimal dose of44-Gy radiation based on the individual surgical resection and the tumorburden. The results confirm that patient-specific dosing can be readily andconsistently performed. The trial also monitored overall survival from thetime of Neuradiab administration to patient death. The 21 patient trialdemonstrated a median overall survival of 90.6 weeks which represents anencouraging increase in survival compared to the historical control of 64weeks in the current standard of care. The optimal dose of 44 + 10% Gyinternal radiation boost to this population was designed based upon a previousmeta-analysis of the Neuradiab population that had been treated at Dukeallowing for an evaluation of therapeutic target dose based upon benefit/riskprofiles (Akabani G, et al., J Nucl Med. 1999;40:631 - 638.). The presentstudy confirms the standard execution of a personalized dosing that will bedone in each patient between the time of surgery and initiation of standard ofcare therapy and also confirms the safety and benefit of the patient-specificdosing.
In preparation for its pending multi-center Phase III trial, the Companyhas completed the final validation phase of the manufacturing process forNeuradiab under Good Manufacturing Practices (GMP). The initial manufacturingdata were reviewed with the U.S. Food and Drug Administration (FDA) in arecently held guidance meeting. Bradmer has qualified the initial clinicalsites in the study, received IRB approval or is in the proce
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