Hemogenyx Pharmaceuticals plc (LSE: HEMO), a biopharmaceutical company dedicated to developing innovative therapies for blood diseases, on Wednesday announced the timeline for opening the first clinical site for its lead asset, HEMO-CAR-T (HG-CT-1). This therapy targets relapsed/refractory acute myeloid leukemia (AML) in adults.

Preparations for clinical testing, including contracts and budgeting, have been successfully completed. Institutional Review Board (IRB) approval for the initial clinical site is expected by the second week of November, with a Site Initiation Visit (SIV) planned for the third week of November, marking the official start of the Phase I trial.

Designed as a dose-escalation study, this trial aims to evaluate the safety profile of HG-CT-1 in adult patients with R/R AML. Key secondary objectives include assessing efficacy based on AML-specific response criteria, overall survival rates, progression-free survival, and duration of response in patients achieving clinical responses. These objectives are critical for determining the clinical impact of HG-CT-1 on this patient population, which currently has limited treatment options.

Acute myeloid leukemia, the most common form of acute leukemia in adults, has a low five-year survival rate of less than 30%. Current treatments primarily involve chemotherapy, highlighting the need for new therapies like those being developed by Hemogenyx Pharmaceuticals.

CAR-T therapy, the foundation of HG-CT-1, modifies a patient's T-cells to recognize and attack cancer cells, potentially offering a more effective and less toxic treatment alternative. Hemogenyx Pharmaceuticals, headquartered in London, operates US subsidiaries Hemogenyx Pharmaceuticals LLC and Immugenyx LLC in New York City, focusing on developing new medicines for blood and autoimmune diseases.