Patience Required23 Oct 2025 08:28
Hemogenyx published a schedule in October 2024 showing that the first clinical site for HG-CT-1 in adults was expected to get IRB approval by mid-November and the site initiation visit in the third week of November.
They announced in March 2025 that the first patient had been treated and passed initial safety.
In June 2025 they announced regulatory clearance (via the U.S. Food and Drug Administration) to proceed with a pediatric expansion of the Phase I trial.
In August 2025 they announced completion of the first adult dose cohort (third patient treated) and stated that, “pending no dose-limiting toxicities, Hemogenyx plans to advance to a second adult dose cohort at twice the initial dose, while simultaneously initiating recruitment for the pediatric arm.”
Hemogenyx has not yet moved into a large Phase II or Phase III “second trial” for HG-CT-1 — they are still in the Phase I adult dose escalation stage.
They must complete safety monitoring of the low-dose adult cohort, obtain DSMB clearance, then open higher dose cohort + pediatric arm.
The “delay” is likely just the normal pace of complex cell therapy development, rather than any unexpected hold-up.
Whilst the shareholders become impatient, we mustn’t forget Hemo & MDA have to build in a safety review period, Hemo have a manufacturing scale up to get to grips with, site initiation & regulatory site approval, all of this and more before committing to any timeline for next treatment.
The Phase 1 trial and release of information relating to it, has been timely and informative, lets us now exercise a little patience in allowing Hemo to ensure they are fully match fit for Phase 2 and Paediatric treatment.