Actinium Pharmaceuticals (NYSE MKT:ATNM) is moving forward with enrollment and treatment of additional patients in its clinical trial for acute myeloid leukemia (AML) in patients over the age of 60.
Actinium will proceed with patient screening and enrollment for the fourth cohort, who, in keeping with trial protocol, will be injected with two doses, four-to-seven days apart of its investigational new drug, Actimab-A, at a higher activity level of 2.0 µCi/kg per dose.
In the previously completed third cohort, patients received two doses of Actimab-A at 1.5 µCi/kg per dose. Two out of three Actimab-A treated patients achieved complete remission with different degrees of hematological recovery (CRi). These responses were documented in the settings of high pre-treatment leukemia burdens of up to 80% in the bone marrow.
Kaushik Dave
In the second cohort treated at a lower dose level of Actimab-A of 1.0 µCi/kg per dose, one patient achieved CRi.
“As we start this last dose level in the Phase 1 portion of our trial, we are very encouraged with results so far,” Kaushik Dave, president and CEO, said in a statement. “We hope to establish the maximum tolerated dose soon, which would allow us to proceed with the Phase 2 portion of the trial, as agreed with the FDA.”
The trial is a prospective, open-label study, designed to determine the safety and efficacy of Actimab-A in newly diagnosed AML patients who cannot tolerate current high dose chemotherapeutic regimens.
