9th May 2023 15:16
Hemogenyx Pharmaceuticals PLC - London-based biopharmaceutical group developing new therapies and treatments for deadly blood diseases - Submits investigational new drug application seeking authorisation from the US Food & Drug Administration to begin a phase 1 clinical trial of its lead product chemic antigen receptor T-cells, or Hemo-Car-T, for treating acute myeloid leukemia.
Says the application follows "successful work on manufacturability, quality, safety and other key parts" of developing Hemo-Car-T. Says it plans to initiate a phase 1 clinical trial of Hemo-Car-T, once the clinical investigation plan proposed in the IND submission has been cleared to proceed by the FDA.
Co-Founder & Chief Executive Officer Vladislav Sandler says: "We are pleased to have reached this milestone with Hemo-Car-T. We are committed to advancing therapies for blood diseases, and our work to address [acute myeloid leukemia], which currently has poor survival rates, is an essential part of that commitment."
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By Greg Rosenvinge, Alliance News reporter
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