This PQ run was a part of the Company's plan to address the
This PQ run is the only manufacturing run required for the submission of a complete response to the CH of the IND application to the FDA for HEMO-CAR-T. It was the key remaining step prior to applying 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. Following the successful completion of all tests across the PQ run, data will be compiled for inclusion in the complete response submission pack.
Dr
About AML and CAR-T Therapy
AML, 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
CAR-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.
Market Abuse Regulation (MAR) Disclosure
Certain 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
Contact:
Dr
Email: headquarters@hemogenyx.com
Email: peter.redmond@hemogenyx.com
Tel: +44 (0)20 3470 0470
Tel: +44 (0)20 7469 0930
About
The Company is a pre-clinical stage biopharmaceutical group developing new medicines and treatments to treat blood and autoimmune disease and to bring the curative power of bone marrow transplantation to a greater number of patients suffering from otherwise incurable life-threatening diseases.
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