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ARTICLE | Clinical News

Actinium reports Phase II data for Actimab-A in AML

January 5, 2018 9:52 PM UTC

Actinium Pharmaceuticals Inc. (NYSE-M:ATNM) reported preliminary data from 13 evaluable patients ages 60 and older with newly diagnosed acute myelogenous leukemia (AML) who were unable to tolerate induction therapy in the Phase II portion of a Phase I/II trial showing that a 2 μCi/kg/fraction dose of Actimab-A on days 1 and 8 led to an overall response rate (ORR) of 69%. Additionally, Actimab-A led to a median reduction in bone marrow blasts of 98%. Data were presented at the American Society of Hematology meeting in Atlanta.

The open-label, U.S. trial is enrolling 53 patients and the company said newly enrolled patients will receive Actimab-A at a 1.5 μCi/kg/fraction dose. The trial’s primary endpoints are maximum tolerated dose (MTD) (Phase I) and complete response rate (Phase II). Secondary endpoints include progression-free survival (PFS), overall survival (OS), leukemia-free survival (LFS) and safety...

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