August 15, 2025 — Leads & Copy — Hemogenyx Pharmaceuticals plc (LSE:HEMO) has successfully treated the third patient in its Phase I clinical trial of HG-CT-1, a CAR-T cell therapy for relapsed or refractory acute myeloid leukemia (R/R AML) in adults. The company secured special permission from the FDA to treat the final participant in the first adult dose cohort, reflecting its ability to navigate complex clinical challenges. Completion of the first adult dose cohort represents a key milestone. If no dose-limiting toxicities are observed, Hemogenyx plans to advance to the second adult dose cohort at twice the initial dose and initiate recruitment for the pediatric arm of the trial.
The Phase I trial is a dose-escalation study assessing safety and collecting data on anti-leukemic activity, overall survival, progression-free survival, and duration of response. The first two patients treated with HG-CT-1 remain alive at six months and three months post-treatment, respectively.
Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, expressed pride in the team’s persistence in working with the FDA and stated that the company is well positioned to move into the higher-dose cohort and open the pediatric arm.
Dr. Vladislav Sandler, Chief Executive Officer & Co-Founder, headquarters@hemogenyx.com
Peter Redmond, Director, peter.redmond@hemogenyx.com
Source: Hemogenyx Pharmaceuticals plc
