Hemogenyx Pharmaceuticals PLC (LSE:HEMO, OTC:HOPHF) has announced the timeline for its upcoming phase I clinical trial of HEMO-CAR-T, a new treatment for adult patients with relapsed or treatment-resistant acute myeloid leukaemia, a severe form of blood cancer.
It has finalised all necessary preparations for the study's first site to open, with the required approval expected by mid-November.
Once the Institutional Review Board approves, Hemogenyx will conduct a site initiation visit, planned for the third week of next month, to formally launch the study.
This initial evaluation phase will examine safety through a structured dose-escalation process, helping researchers determine the appropriate levels of the treatment to be administered.
Additional goals include measuring the effectiveness of HEMO-CAR-T, formally designated HG-CT-1, assessing survival rates, and evaluating the duration of response among patients who show clinical improvements.
The launch marks a significant step for Hemogenyx, which aims to provide new hope for patients with limited treatment options.
CEO Dr Vladislav Sandler said: "Launching this phase I clinical trial for HG-CT-1 will mark a critical step forward in our mission to develop transformative therapies for patients battling relapsed and refractory acute myeloid leukaemia.
"For patients who have few remaining treatment options, HG-CT-1 offers a potentially life-saving solution.
"We are eager to initiate this trial and generate data that will be essential in advancing this therapy toward broader clinical use.
"This milestone underscores our commitment to innovation and our dedication to addressing the urgent needs of patients with severe blood cancers."
The Hemogenyx immunotherapy has been developed to target and destroy acute myeloid leukaemia cells.
It uses modified immune cells, called T cells, which are programmed to recognise and attack leukaemia cells specifically, aiming to improve treatment options for blood cancer.