Actinium Pharma (ATNM) Initiates Phase 2 Trial of Actimab-A in AML

September 27, 2016 7:03 AM EDT
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Actinium Pharmaceuticals, Inc. (NYSE: ATNM) initiated a Phase 2 clinical trial of Actimab-A in patients newly diagnosed with Acute Myeloid Leukemia (AML) who are over the age of 60. Actimab-A, Actinium's most advanced alpha particle immunotherapy (APIT) program consists of the CD33 targeting monoclonal antibody, HuM195, and the alpha-emitting radioisotope, actinium-225.

“We are excited to have initiated the Phase 2 trial of Actimab-A for elderly patients who are newly diagnosed with AML and ineligible for 7+3 treatment. These older patients face a poor prognosis and have limited viable treatment options” said Sandesh Seth, Actinium’s Executive Chairman. “We are encouraged by the safety and efficacy signals we have seen thus far and look forward to the execution of this trial with an eye toward interim and top-line results which are both expected in 2017.”

This Phase 2 clinical trial is a multicenter, open-label study that will enroll 53 patients. Patients will receive 2.0 µCi/kg/fractionated dose of Actimab-A via two injections given at day 1 and day 7. The Phase 2 trial is designed to evaluate complete response rates at up to day 42 after Actimab-A administration, where complete response is defined as complete remission (CR) or complete remission with incomplete platelet recovery (CRp). A formal interim analysis is expected to occur in mid-2017 with topline results expected in the second half of 2017. The Phase 2 trial will include peripheral blast burden as an inclusion criteria and in patients with high peripheral blast (PB) burden, the use of Hydroxyurea will be mandated with the goal of bringing PB burden below a key threshold number that the Company has identified from two previously complete Phase 1 clinical trials totaling 38 patients. In addition, the use of granulocyte colony-stimulating factors (GCSF) will be mandated. Low dose cytarabine has been eliminated from the protocol and the Phase 2 clinical trial will evaluate Actimab-A as a monotherapy. The secondary endpoint of the Phase 2 trial will be overall survival.

Dr. Joseph Jurcic, Principal Investigator of the Actimab-A Phase 2 trial and Director of Hematologic Malignancies; Professor of Medicine at Columbia University Medical Center said, “Actimab-A has been studied in two clinical trials thus far in patients with AML ranging in age from 18-87 who had a wide array of genetic risk factors that were at various stages of disease progression. Actimab-A has shown a promising safety and efficacy profile thus far that we believe differentiates Actimab-A from other CD33 targeting drug candidate, which is an exciting space in AML. Our PB burden hypothesis indicates that of all factors related to AML including age, stage of disease and genetic factors, peripheral blast burden showed to be the most relevant. With PB burden serving as an inclusion criteria in this Phase 2 trial and the use of Hydroxyurea being mandated in patients with PB burden above a key threshold we look forward to conducting this clinical trial in this older patient population that has a great unmet medical need.”

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