In This Article:
Hemogenyx Pharmaceuticals Receives IRB Approval for Phase 1 Clinical Trial of HEMO-CAR-T (HG-CT-1)
LONDON, UK / ACCESSWIRE / November 22, 2024 / Hemogenyx Pharmaceuticals plc (LSE:HEMO), a biopharmaceutical company developing innovative therapies and treatments for blood diseases, is pleased to announce that the Institutional Review Board (IRB)of the Company's first clinical site has granted approval to initiate a Phase I clinical trial of the Company's lead asset, HEMO-CAR-T, which has now been given the formal designation HG-CT-1, for the treatment of relapsed/refractory (R/R) acute myeloid leukemia (AML) in adults.
The proposed Phase 1 clinical trial is designed as a dose escalation study to assess the safety of HG-CT-1 in adult patients with R/R AML. Secondary clinical objectives are crucial for evaluating the broader impact of HG-CT-1 and include:
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Estimating the efficacyof HG-CT-1 based on standard clinical response criteria for AML.
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Estimating overall survival (OS)in evaluable subjects.
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Estimating progression-free survival (PFS)in evaluable subjects.
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Estimating duration of response (DoR)in evaluable subjects who achieve a clinical response.
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. This IRB approval represents a significant 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:
"We are excited to receive IRB approval to proceed with our PhaseI clinical trial of HEMO-CAR-T. This trial is a critical step in the development of our CAR-T therapy for AML patients who have exhausted other treatment options. With this study, we aim to establish the safety profile of HG-CT-1 and gather preliminary efficacy data that could pave the way for future therapeutic development."
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.