Hemogenyx Pharmaceuticals (LSE: HEMO) shares jumped more than 11% on Wednesday after the company announced a milestone in the development of its HG-CT-1 CAR-T therapy.
The independent Data Safety Monitoring Board (DSMB) has cleared the company to proceed to the next dose level in its Phase I clinical trial for relapsed or refractory acute myeloid leukemia (R/R AML) in adult patients.
This news is coupled with the grant of Restricted Share Units (RSUs) to the Hemogenyx team.
This clearance follows a review of safety data from the first three adult patients treated at the initial dose level, where no dose-limiting toxicities were observed.
The trial's progression to the next dose cohort, as per the FDA-approved protocol, is a crucial step forward. Further boosting the company's prospects, the DSMB's decision also allows for the initiation of pediatric patient recruitment at the lowest dose level of HG-CT-1.
The Phase I study is designed as a dose-escalation trial, evaluating the safety, tolerability, and preliminary efficacy of HG-CT-1 in both adult and pediatric patients with R/R AML. Secondary endpoints include assessing AML-specific responses, progression-free survival, duration of response, and overall survival.
As recognition for their contribution to the HG-CT-1 program, Hemogenyx has granted a total of 6,000 Restricted Share Units (RSUs) to key team members. This move aligns the team's interests with those of shareholders, incentivizing their ongoing efforts in driving the company's clinical and operational success.
Dr. Vladislav Sandler, CEO & Co-Founder of Hemogenyx Pharmaceuticals, commented, “We are very pleased to have received DSMB clearance to advance HG-CT-1 to the next dose level. This important milestone marks continued progress in our clinical development program and further validates the safety profile of our CAR-T therapy.” He further added his appreciation to the Hemogenyx team for their dedication and scientific rigor.
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