Hemogenyx Pharmaceuticals PLC: A Milestone in AML Treatment

Hemogenyx Pharmaceuticals PLC (LSE: HEMO) has announced the successful completion of the Site Initiation Visit (SIV) at the first clinical site for its Phase I clinical trial of HG-CT-1, also known as HEMO-CAR-T. This pivotal trial aims to assess the safety of HG-CT-1 in adult patients suffering from relapsed/refractory acute myeloid leukemia (AML). With patient recruitment slated to begin shortly, the trial will follow a dose escalation approach.

The completion of the SIV marks a significant milestone for Hemogenyx Pharmaceuticals, as it paves the way for the commencement of patient recruitment and the initiation of the trial. This event signals the official launch of the Phase I clinical trial, with the first clinical site now ready to accept and treat participants.

Dr. Vladislav Sandler, CEO and Co-Founder of Hemogenyx, emphasized the importance of this milestone, highlighting the urgent need for innovative therapies for AML, which currently has limited treatment options. He expressed excitement about moving forward and assessing the treatment's safety and potential efficacy for patients with R/R AML.

Acute myeloid leukemia is recognized as the most prevalent type of acute leukemia in adults, with extremely low five-year survival rates of under 30%. Current treatments, primarily chemotherapy, can be harsh and may not be effective for all patients. Hemogenyx aims to advance a less toxic and potentially more effective treatment option through its CAR-T therapy, which modifies a patient’s T-cells to better recognize and destroy cancer cells.

As a clinical stage biopharmaceutical firm, Hemogenyx is also working on developing various product candidates and platform technology designed to enhance the treatment landscape for blood diseases and autoimmune disorders. With HG-CT-1 in the clinical trial phase, the company is one step closer to addressing critical unmet medical needs within the oncology field.

This announcement has implications not only for the company and its long-term value but also for the broader biopharmaceutical market focused on innovative cancer therapies. The successful completion of the SIV and the initiation of the Phase I clinical trial indicate that Hemogenyx Pharmaceuticals is on track to deliver on its promise of advancing a potentially transformative therapy for AML patients.



The Phase I clinical trial of HG-CT-1 is designed as a dose-escalation study to evaluate the safety of HG-CT-1 in adult patients with R/R AML. Key secondary objectives include assessing the therapy’s impact on AML-specific response criteria, overall survival (OS) rates among participating subjects, progression-free survival (PFS) in evaluable subjects, and duration of response (DoR) in those who achieve clinical responses. These objectives are crucial for assessing the overall clinical impact of HG-CT-1 on patients with R/R AML, a population with few remaining therapeutic options.

The completion of the SIV and the initiation of the Phase I clinical trial for HG-CT-1 represent a significant step forward in the development of innovative therapies for AML. As Hemogenyx Pharmaceuticals continues to advance its CAR-T therapy through clinical trials, investors and healthcare providers alike should closely monitor the progress of this promising treatment option. The potential impact of HG-CT-1 on the treatment landscape for AML could have far-reaching implications for patients, healthcare providers, and the broader biopharmaceutical market.