Hemogenyx Pharmaceuticals Advances in Leukaemia Treatment with Phase I Clinical Trial of HG-CT-1

Highlights

• Initiation of Clinical Trial: Hemogenyx Pharmaceuticals begins Phase I trial for HG-CT-1, targeting recurrent acute myeloid leukaemia (AML).
• Focus on Safety and Efficacy: Trial evaluates safety, survival rates, and clinical responses in relapsed/refractory AML patients.
• CAR-T Therapy Innovation: HG-CT-1 leverages modified immune cells to address limited treatment options for AML.

Hemogenyx Pharmaceuticals PLC (LSE:HEMO, OTC:HOPHF) announced the initiation of a pivotal Phase I clinical trial for HG-CT-1, a CAR-T therapy aimed at treating relapsed or refractory acute myeloid leukaemia (R/R AML) in adults. This development marks a significant step forward in the fight against one of the most challenging forms of leukaemia, which currently has limited therapeutic options.

The company has opened its first clinical trial site and started recruiting patients at a globally renowned cancer research institution. The study is designed as a dose-escalation trial to evaluate the safety profile of HG-CT-1, alongside secondary objectives such as progression-free survival, overall survival rates, and the duration of response in patients showing clinical improvements.

Addressing Unmet Needs in AML Treatment

Acute myeloid leukaemia (AML) is the most prevalent acute leukaemia among adults, with a five-year survival rate of less than 30%. Current treatment options, such as chemotherapy, often come with significant side effects and limited effectiveness, especially for those experiencing relapse or resistance.

HG-CT-1 represents a novel approach to addressing these challenges through CAR-T therapy, which utilizes a patient’s own immune cells to target and destroy cancer cells.

The treatment involves:

1. T-cell Isolation: Extracting immune cells from the patient.
2. Genetic Modification: Engineering the cells with a CAR gene construct to recognize cancer.
3. Amplification: Growing the modified cells to sufficient numbers in a laboratory.
4. Reintroduction: Administering the cells back to the patient to attack the leukaemia.

This innovative process aims to provide a more targeted and potentially less harmful alternative to chemotherapy.

Pioneering Trial Objectives

Dr. Vladislav Sandler, Hemogenyx’s chief executive and co-founder, emphasized the significance of this trial. “The opening of our first clinical site is a milestone in our mission to revolutionize the treatment landscape for relapsed and refractory acute myeloid leukaemia,” he stated.

The primary goal of the trial is to establish the safety of HG-CT-1, while secondary objectives include:

• Assessing the therapy’s impact on AML-specific clinical criteria.
• Measuring overall and progression-free survival rates.
• Evaluating the duration of response in participants showing clinical improvements.

“These objectives are pivotal for determining the clinical impact of HG-CT-1 in patients who have exhausted other treatment options,” Hemogenyx added in its statement.

A Glimpse into the Future of AML Treatment

With chemotherapy as the current standard, HG-CT-1 offers a potentially transformative solution for R/R AML patients. Hemogenyx’s approach aligns with the broader shift in oncology towards precision medicine, aiming to improve patient outcomes while reducing treatment-related toxicity.

As Hemogenyx advances its clinical trial, the outcomes of this study could redefine the treatment landscape for AML. By addressing the limitations of existing therapies, the company’s CAR-T platform has the potential to provide hope to a patient population with significant unmet medical needs.

The trial’s results will be closely watched as the company progresses in its mission to improve survival rates and enhance the quality of life for AML patients.