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"With this positive response from the FDA, we are now in a position tobegin treating patients with this potentially vital new therapy forglioblastoma multiforme," said Alan M. Ezrin, Ph.D., President and ChiefExecutive Officer of Bradmer. "This is a major milestone for Bradmer. We willnow turn all of our collective efforts to supporting the clinical trial sitesfor the successful execution of this landmark study and look forward toenrolling patients at our initial centers."
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The Phase III trial, named the GLASS-ART Trial, is currently screening forpatients and will investigate Neuradiab(TM) as an adjuvant therapy to surgery,external beam radiation and temozolomide in 760 patients with newly diagnosedglioblastoma multiforme. The randomized trial is expected to be conducted atleading brain tumor treatment centers across the United States.
About Neuradiab(TM)
Neuradiab(TM) is a monoclonal antibody, conjugated to radioactive iodine,used to treat glioblastoma multiforme (GBM), the most common and advanced formof brain cancer. Neuradiab(TM) delivers tumor-killing radiation specificallyto residual brain tumor cells after surgery, with minimal impact on normalbrain tissue. During the course of development at the internationally renownedPreston Robert Tisch Brain Tumor Center at Duke University, over US$60 millionin research grants and related support was invested to produce a series ofPhase I and Phase II clinical trials on Neuradiab(TM) and other closelyrelated technologies. Approximately 200 brain cancer patients, including over160 with GBM, have been treated with the Neuradiab(TM) therapy regimen, andsurvival benefits have significantly exceeded historical controls in eachcompleted trial. Neuradiab(TM) has been formerly referred to in literature as131I anti-tenascin monoclonal antibody 81c6.
Each year up to 30,000 new cases of GBM are diagnosed in the world's sevenlargest healthcare markets. The current standard of care for GBM patients issurgical resection followed by radiation and temozolomide. GBM tumorstypically have infiltrating edges that are very difficult to completely removewith surgery. The Neuradiab(TM) therapy is delivered directly into thesurgical resection cavity in a separate procedure after the initial surgery.Neuradiab(TM) delivers a concentrated level of radiation specifically to theremaining cancer cells by targeting tenascin. Tenascin is a proteinover-expressed in 99% of GBM cells but absent from normal brain cells.
About the GLASS-ART Trial (www.glassarttrial.com)
This Phase III study derives its name from its description: GBMLocoregional Agent Survival Study - Antitenascin Radiolabeled antibody TherapyTrial. The study is designed to determine the survival benefit derived fromadding Neuradiab(TM) to the current standard of care therapy, consisting ofsurgery, radiation and adjuvant chemotherapy (temozolomide), for patientsdiagnosed with primary glioblastoma mulitforme and whether the drug regimen issafe. The randomized trial wi
