Biopharmaceutical group Hemogenyx Pharmaceuticals plc (LSE: HEMO) confirmed on Wednesday that the third patient in its Phase I clinical trial of HG-CT-1 CAR-T therapy for relapsed/refractory acute myeloid leukaemia (AML) has successfully passed initial safety evaluation.
The treatment was well tolerated and met the trial's predefined safety criteria. Early signs of efficacy were observed, with standard testing showing no detectable AML cells in the patient following treatment. The patient will continue to be monitored under the FDA-approved protocol to assess secondary endpoints, including response rates, survival and durability of treatment.
Safety data from the first three patients at the lowest dose will now be reviewed by an independent Data Safety Monitoring Board to determine whether dose escalation can proceed.
HG-CT-1 is being tested in a dose-escalation Phase I trial designed to evaluate safety and tolerability, while also collecting long-term efficacy data.
Hemogenyx is developing new treatments for blood and autoimmune diseases through a pipeline of product candidates and platform technologies.
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