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LONDON - Hemogenyx Pharmaceuticals plc (LSE:HEMO) has treated the third patient in its Phase I clinical trial of HG-CT-1, completing the first adult dose cohort for its CAR-T cell therapy targeting relapsed or refractory acute myeloid leukemia (R/R AML).
The treatment was administered after the company secured special permission from the U.S. Food and Drug Administration under exceptional circumstances, according to a press release issued Friday.
The first dose cohort received the lowest planned dose of HG-CT-1. Pending no dose-limiting toxicities, Hemogenyx plans to advance to a second adult cohort that will receive twice the initial dose, while simultaneously initiating recruitment for a pediatric arm of the trial.
The company reported that the first two patients treated with HG-CT-1 remain alive at six months and three months post-treatment, respectively. The Phase I trial is designed primarily to assess safety, with secondary endpoints including anti-leukemic activity, overall survival, progression-free survival, and duration of response.
"Completing the first adult dose cohort is a major achievement in our Phase I trial of HG-CT-1," said Dr. Vladislav Sandler, CEO and Co-Founder of Hemogenyx Pharmaceuticals, in the statement.
The trial represents the company’s efforts to develop new treatment options for AML, an aggressive blood cancer with limited therapeutic alternatives, particularly for patients who have relapsed or become resistant to conventional treatments.
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