Hemogenyx Pharmaceuticals PLC outlines the schedule for its Phase I clinical trial

October 30, 2024 06:53 PM AEDT | By Team Kalkine Media

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Hemogenyx Pharmaceuticals PLC outlines the schedule for its Phase I clinical trial — Image source: Shutterstock

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Highlights

Hemogenyx Pharmaceuticals plc has announced the schedule for launching its Phase I clinical trial for HEMO-CAR-T (HG-CT-1), targeting relapsed/refractory acute myeloid leukemia (AML) in adults.

Institutional Review Board (IRB) approval for the initial clinical site is anticipated by mid-November, with a Site Initiation Visit (SIV) planned for the third week of November.

The trial aims to evaluate the safety and efficacy of HG-CT-1, a promising CAR-T therapy offering potential solutions for patients with limited treatment options.

Hemogenyx Pharmaceuticals plc (LSE:HEMO), a biopharmaceutical company specializing in innovative therapies for blood diseases, has unveiled its schedule for the commencement of the first clinical site for HEMO-CAR-T, also known as HG-CT-1. This therapy is specifically designed for adults with relapsed/refractory acute myeloid leukemia (AML).

The Company has finalized essential contracts and budgeting preparations to advance HG-CT-1 into clinical testing. Anticipation surrounds the Institutional Review Board (IRB) approval at the initial clinical site, expected in the second week of November. Following this clearance, a Site Initiation Visit (SIV) is slated for the third week of November, signaling the official launch of the Phase I clinical trial.

This trial is structured as a dose-escalation study focused on assessing the safety profile of HG-CT-1 in adult patients suffering from R/R AML. Key secondary objectives will evaluate the therapy’s impact on specific clinical outcomes, including:

The efficacy of HG-CT-1 according to AML-specific response criteria.
Overall survival (OS) rates among participants.
Progression-free survival (PFS) for evaluable subjects.
Duration of response (DoR) in those achieving clinical responses.

These objectives are critical for understanding the overall clinical impact of HG-CT-1 on patients facing limited therapeutic options. The initiation of this trial represents a significant milestone for Hemogenyx Pharmaceuticals, enabling advancement into clinical testing at a leading cancer research institution.

Dr. Vladislav Sandler, CEO and Co-Founder, emphasized the importance of this trial in fulfilling the Company’s mission to develop transformative therapies for patients with R/R AML, a demographic with urgent medical needs. The development of effective therapies for AML could substantially improve treatment outcomes and survival rates for affected individuals.

Hemogenyx Pharmaceuticals continues to pursue its commitment to innovation and addressing the pressing needs of patients battling severe blood cancers.

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