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FDA Consents to Phase I Trials of HEMO-CAR-T
FDA Consents to Phase I Trials of HEMO-CAR-T.
About this update from Hemogenyx Pharmaceuticals Plc
[{"type":"text","content":"\n\n9 February 2024\n \nHemogenyx Pharmaceuticals plc \n(\"Hemogenyx Pharmaceuticals\" or the \"Company\")\n \n \nFDA Consents to Phase I Trials of HEMO-CAR-T\n \nHemogenyx Pharmaceuticals plc (LSE: HEMO) is pleased to announce that it has been informed by the U.S. Federal Food and Drug Administration (\"FDA\") that it has lifted the clinical hold on the Investigational New Drug (IND) application for HEMO-CAR-T for the treatment of acute myeloid leukemia (\"AML\"). The FDA confirmed that the Company had addressed all issues identified in its prior clinical hold letter satisfactorily and consents to the Company proceeding with its Phase I clinical study of HEMO-CAR-T.\nDr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: \"We are extremely pleased with the FDA's decision to lift the clinical hold. We now look forward to accelerating clinical development of HEMO-CAR-T and to offering patients a potentially life-saving treatment. The removal of the clinical hold was made possible by the hard work and dedication of the entire Hemogenyx Pharmaceuticals team and its Board of Directors and advisors.\"\n \nAbout AML and CAR-T Therapy\nAML, the most common type of acute leukemia in adults, has poor survival rates (a five-year survival rate of less than 30% in adults) and is currently treated using chemotherapy, rather than the potentially more benign and effective form of therapy being developed by Hemogenyx Pharmaceuticals. The successful development of a new therapy for AML would have a major impact on treatment and survival rates for the disease.\nCAR-T therapy is a treatment in which a patient's own T-cells, a type of immune cell, are modified to recognize and kill the patient's cancer cells. The procedure involves: isolating T-cells from the patient; modifying the isolated T-cells in a laboratory using a CAR gene construct (which allows the cells to recognize the patient's cancer); amplifying (growing to large numbers) the newly modified cells; and re-introducing the cells back into the patient.\n \nMarket Abuse Regulation (MAR) Disclosure\nCertain information contained in this announcement would have been inside information for the purposes of Article 7 of Regulation No 596/2014 (as it forms part of UK domestic law by virtue of the European Union (Withdrawal) Ac...