Bradmer Medical Isotope Supply For Phase III Tr...( TSX...),Health

TSX: BMR

TORONTO, Dec. 10 /PRNewswire-FirstCall/ - Bradmer Pharmaceuticals Inc., a biopharmaceutical company dedicated to the development and commercialization of cancer therapies, today announced that the start of Company's planned Phase III trial of Neuradiab, a murine monoclonal antibody radiolabeled with Iodine-131 (I-131), is unaffected by the recent shortage of medical isotopes from a nuclear facility in Chalk River, Ontario. Bradmer procures its I-131 material used to prepare Neuradiab from commercial sources outside North America as well as a back up facility that are not affected by the recent events at Chalk River.

"The medical isotope production issues have received a significant amount of attention recently, and we felt it would be appropriate to update our shareholders and stakeholders on the situation as it relates to Bradmer. We made decisions earlier this year that ensured both the clinical and commercial supplies of the radioisotope for our product candidate, Neurabiab," said Alan M. Ezrin, Ph.D., President and Chief Executive Officer of Bradmer. "Our formulation work, completed earlier this year, indicated that the I-131 we use yielded consistent and reproducible product which we have validated for clinical use at a commercial scale for the upcoming Phase III trial. In addition, we have made contingency plans to ensure we can modify our protocol accordingly to conduct the imaging flow studies that are required in our Phase III trial if the shortage of Technetium as a diagnostic agent continues due to the current events."

Bradmer has invested the better part of the past year securing and validating the commercial production of Neuradiab. The Company has completed the final validation phase of the manufacturing process for the drug and will present a complete chemistry, manufacturing and controls (CMC) update to the United States Food and Drug Administration (FDA) for their review and meet wit
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