Hemogenyx Pharmaceuticals PLC on Monday said it has received a review letter from the US Food & Drug Administration confirming its placement of Hemo-Car-T on clinical hold.
Hemogenyx shares rose 14% to 1.67 pence each on Monday morning in London.
The London-based biopharmaceutical group developing new therapies and treatments for deadly blood diseases said the treatment has been placed on hold due to splicing that occurs during the manufacture of the lentivirus used to produce Car-T cells.
Hemogenyx said it has identified the source of the splicing deficiency and has developed a method to eliminate it, adding that the lentivirus is now being re-manufactured.
Last month, the FDA announced that it had placed Hemo-Car-T on hold pending the review letter.
The letter also included suggestions on how to improve the safety of the treatment, which do not contribute to the clinical hold and can be dealt with ‘readily’, the firm said.
Chief Executive Vladislav Sandler commented: ‘We are confident that we will be able to address the FDA’s questions and concerns regarding the [Investigational New Drug]. [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.’
Car-T therapy sees a patient’s own T-cells modified to recognise and kill their cancer cells.
Copyright 2023 Alliance News Ltd. All Rights Reserved.