Hemogenyx Pharmaceuticals PLC -hemo London-based biopharmaceutical group developing new therapies and treatments for deadly blood diseases - Notes receipt of notice from the US Food & Drug Administration over its investigational new drug application for its product candidate Chimeric Antigen Receptor T-cells, or Hemo-Car-T. Says Hemo-Car-T is a treatment for acute myeloid leukemia. Says FDA put Hemo-Car-T on clinical hold, pending an FDA letter to be received within 30 days detailing what additional information needs to be provided by Hemogenyx. Hemogenyx submitted the investigational new drug application in early May, seeking authorisation to begin a phase 1 clinical trial of Hemo-Car-T.
Co-Founder & Chief Executive Officer Vladislav Sandler says: ‘We are confident that we will be able to address the FDA’s questions and concerns regarding the investigational new drug application. Acute myeloid leukemia has poor survival rates and we are eager to resolve this hold and continue down the treatment development pathway toward saving lives.’
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