{"id":112221,"title":"Hemogenyx Pharma Plc (LON:HEMO) Submission of Complete Response to Clinical Hold","publisher":"Share Talk","author":"sharetalk","published":"2024-01-16T12:01:43+00:00","modified":"2024-01-16T12:01:43+00:00","canonical_url":"https://www.share-talk.com/hemogenyx-pharma-plc-lonhemo-submission-of-complete-response-to-clinical-hold/","markdown_url":"https://www.share-talk.com/hemogenyx-pharma-plc-lonhemo-submission-of-complete-response-to-clinical-hold.md","json_url":"https://www.share-talk.com/hemogenyx-pharma-plc-lonhemo-submission-of-complete-response-to-clinical-hold.json","category":"Health","categories":["Health","Healthcare","Pharmaceutical"],"tags":["biopharmaceutica","COVID-19","Dr Vladislav Sandler","Global Pharma","gold rush","H.C. Wainwright","HEMO","Hemogenyx","Hemogenyx Pharma","Pharma","Share Talk","Vladislav Sandler"],"featured_image":"https://i0.wp.com/www.share-talk.com/wp-content/uploads/2023/11/Hemogenyx-Pharma-27_11_23.jpg?fit=1200%2C800&quality=89&ssl=1","format":"news","language":"en-GB","content":"**Submission of Complete Response to Clinical Hold for HEMO-CAR-T IND**\n\n**Hemogenyx Pharmaceuticals plc (LSE: HEMO)** announces the submission of a complete response to the previously announced Clinical Hold (“CH”) of the Investigational New Drug (“IND”) application to the US Food and Drug Administration (“FDA”) for HEMO-CAR-T.  A complete response is necessary to apply for the lifting of the CH which is needed to obtain consent from the FDA to commence Phase I clinical trials of HEMO-CAR-T.\n\nDr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented: “We are pleased to have filed a complete response to the FDA addressing their concerns that resulted in a CH of the HEMO-CAR-T IND. We look forward to becoming a clinical stage biopharmaceutical company once consent is received from the FDA.”\n\n**About AML and CAR-T Therapy**\n\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.\n\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\nEnquiries:\n\n|   |   |\n| --- | --- |\n| Hemogenyx Pharmaceuticals plc | [https://hemogenyx.com](https://hemogenyx.com/) |\n| Dr Vladislav Sandler, Chief Executive Officer & Co-Founder | [headquarters@hemogenyx.com](mailto:headquarters@hemogenyx.com) |\n| Peter Redmond, Director | Peter.redmond@hemogenyx.com |"}