Actinium Pharma Says Completes Planned Phase 1 Actimab-A CLAG-M Combination Trial

(RTTNews) - Actinium Pharmaceuticals, Inc. (ATNM) on Monday provided an update on the Actimab-A CLAG-M combination Phase 1 trial being conducted at the Medical College of Wisconsin or MCW, in patients with Relapsed or Refractory ("R/R") Acute Myeloid Leukemia (AML) age 18 and above, who are fit for intensive therapy.

The company noted that all patients in the third dosing cohort, which was scheduled as the final cohort of the planned Phase 1 dose escalation trial, completed treatment with a 0.75 uCi/kg dose of Actimab-A followed by CLAG-M and have cleared their initial safety evaluation.

Actinium Pharma expects results from the planned portion of the Phase 1 trial, including complete safety and efficacy data to be presented by year end.

Previously, it was reported that the second dose cohort demonstrated an 86 percent complete remission rate with 71 percent of patients achieving negative minimal residual disease status.

Based on the safety results thus far, investigators at MCW have indicated they intend to expand the Phase 1 portion of the trial assuming FDA clearance.

"We are excited that the planned portion of the Actimab-A CLAG-M trial has been completed and look forward to presenting results of the trial by year-end. The high rates of remission and MRD negativity with good tolerability seen in this trial thus far demonstrate the potential of our Antibody Radiation Conjugate (ARC) approach and the power of delivering radiation to a highly relevant target such as CD33, particularly in combination with other synergistic modalities," said Dr. Mark Berger, Actinium's Chief Medical Officer.