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Clinical Hold Lift Plan is accepted by FDA
Clinical Hold Lift Plan is accepted by FDA.
About this update from Hemogenyx Pharmaceuticals Plc
[{"type":"text","content":"\n\n14 September 2023\n \nHemogenyx Pharmaceuticals plc \n(\"Hemogenyx Pharmaceuticals\" or the \"Company\")\n \nClinical Hold Lift Plan is accepted by FDA\n \n \nHemogenyx Pharmaceuticals plc (LSE: HEMO), the biopharmaceutical group developing new therapies and treatments for blood diseases, announces that the U.S. Food and Drug Administration (\"FDA\") has accepted the Company's plan to address the FDA's concerns that resulted in a Clinical Hold (\"CH\") of the HEMO-CAR-T Investigational New Drug (\"IND\") application.\nFurther to the announcement on 10 July 2023, Hemogenyx Pharmaceuticals carefully considered the comments provided by the FDA in connection with the CH and responded in August 2023 with a detailed plan, supported by laboratory tests, to address those comments. The Company has now received confirmation from the FDA that the Company's plan satisfactorily addresses the agency's comments.\n \nDr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: \"We are pleased that the FDA has agreed to our plan and preliminary test results to address their concerns regarding our HEMO-CAR-T IND application. We are now working hard to complete the schedule of work set out in the plan and to re-submit the IND as expeditiously as possible in order to move forward with clinical trials of HEMO-CAR-T.\"\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\nCerta...