Hemogenyx Pharmaceuticals PLC (LSE: HEMO, OTC: HOPHF) announced a “major milestone” by launching its first trial site and beginning patient recruitment for the clinical trial of its flagship drug, which is being evaluated as a potential treatment for recurrent leukaemia.
This Phase I trial of HG-CT-1 targets adults with relapsed or refractory acute myeloid leukaemia (R/R AML) and is structured as a dose-escalation study to assess the drug’s safety profile.
Key secondary objectives include assessing the therapy’s impact on the following clinical outcomes:
· Efficacy of HG-CT-1 based on AML-specific response criteria
· Overall survival (OS) rates among participating subjects
· Progression-free survival (PFS) in evaluable subjects
· Duration of response (DoR) in those who achieve clinical responses.
These objectives are pivotal for assessing the overall clinical impact of HG-CT-1 on patients with R/R AML, a population with few remaining therapeutic options. The commencement of this trial represents a major milestone for Hemogenyx Pharmaceuticals, enabling the Company to advance this promising therapy into clinical testing at one of the world’s most prestigious cancer research institutions.
Dr Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented:
“ The opening of our first clinical site for the Phase I trial of HG-CT-1 is a milestone in our mission to revolutionize the treatment landscape for relapsed and refractory acute myeloid leukemia. This trial offers hope to patients who currently face limited treatment options by exploring the safety and potential efficacy of HG-CT-1. We are excited to start this pivotal study.“
About AML and CAR-T Therapy
AML, the most common type of acute leukemia in adults, has poor survival rates (a five-year survival rate of less than 30% in adults) and is currently treated using chemotherapy, rather than the potentially more benign and effective forms of therapy being developed by Hemogenyx Pharmaceuticals. The successful development of a new therapy for AML would have a major impact on treatment and survival rates for the disease.
CAR-T therapy is a treatment in which a patient’s own T-cells, a type of immune cell, are modified to recognize and kill the patient’s cancer cells. The procedure involves: isolating T-cells from the patient; modifying the isolated T-cells in a laboratory using a CAR gene construct (which allows the cells to recognize the patient’s cancer); amplifying (growing to large numbers) the newly modified cells; and re-introducing the cells back into the patient.
Enquiries:
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Hemogenyx Pharmaceuticals plc |
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Dr Vladislav Sandler, Chief Executive Officer & Co-Founder |
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Peter Redmond, Director |
