Actinium Reports Trial To Study Effect Of Actimab-A On MRD In Postremission AML

(RTTNews) - Actinium Pharmaceuticals Inc. (ATNM) said that Dr. Joseph Jurcic, Director of the Hematologic Malignancies Section and Professor of Medicine at Columbia University Medical Center, has initiated Actimab-A MRD, a new clinical trial for patients with AML who are in remission but have detectable minimal residual disease or MRD.

The trial will study the safety/tolerability of Actimab-A in the postremission consolidation setting and include dose finding analyses. The trial will also study the impact of Actimab-A on minimal residual disease or MRD as well as progression-free (PFS) and overall survival rates. The investigational new drug (IND) application for this trial has been cleared by the FDA.

Joseph Jurcic said, "Although patients with AML can achieve complete remissions with induction therapy, the rate of relapse remains high resulting in high mortality rates. Strong evidence exists that minimal residual disease is a major driver of disease relapse and clearly demonstrates the need for improved consolidation therapies that can effectively target MRD.

Based on the clinical profile of Actimab-A to date, I am excited to study this therapy for use as a consolidation therapy. It will be a significant advancement for AML patients if this trial shows the ability to target MRD and reduce relapse rates."

There are an estimated 21,000 patients diagnosed with AML annually in the United States and over 350,000 cases of AML worldwide. According to the National Cancer Institute, 5-year survival for AML patients under age 65 is 45% while 5-year survival for patients over 65 is 6% with the median age of diagnosis of AML patients being 68. With curative intent induction chemotherapy, 45% - 65% of patients can achieve complete remission but up to 80% of patients will relapse despite postremission consolidation treatment.

Currently, non-transplant-based consolidation therapies consist mainly of chemotherapy such as high-dose Cytarabine. The presence of MRD has been shown to be associated with higher rates of relapse and earlier relapse in multiple studies. Recently, the FDA approved a therapy for patients with a certain type of B-cell leukemia who are in remission but have detectable MRD.