Following the release of favorable clinical-trial findings, Actinium Pharmaceuticals Inc. (NYSE: ATNM) shares increased 8.22% to trade at $10.53 at the time of the most recent check.
What outcomes has ATNM disclosed?
Positive top-line findings from the pivotal Phase 3 study for its flagship product candidate, Iomab-B, were released by Actinium (ATNM) today. Patients 55 years of age or older with active illness participated in the SIERRA (Study of Iomab-B in Elderly Relapsed or Refractory AML) experiment (relapsed or refractory AML).
- In the SIERRA trial, a randomized, multicenter, controlled research, Iomab-B was compared to a control arm that permitted all currently available forms of traditional therapy with the goal of transplanting these patients.
- The SIERRA trial’s primary goal, durable complete remission, or dCR, was achieved in the Iomab-B arm compared to the standard treatment arm at 6 months after the first remission following a BMT, achieving statistical significance of p0.0001.
- For patients who require new therapeutic alternatives, ATNM’s important SIERRA study, which was randomized, controlled, and multi-center, has produced these findings.
- With Iomab-B, Actinium hopes to enhance patient outcomes and expand access to BMT; these topline data, given their statistical significance, point us in that direction.
- In order to get the US Food and Drug Administration (FDA) to approve Iomab-B, ATNM promised to keep working on the Biologics License Application (BLA).
How did ATNM achieve top-tier results?
This is a critical turning point in the life of Actinium (ATNM) and a testament to the caliber of its team that performed a ground-breaking investigation in a patient group that is generally thought to be untreatable. Despite ongoing staffing and resource shortages, their dedication and tenacity have paid off in a clinically significant way. The freshly bolstered team is working to carry out ATNM’s aim to use Iomab-B to revolutionize bone marrow conditioning, first in r/r AML and subsequently by expanding on its strong historical clinical performance in a number of hematological conditions. By year’s end, ATNM will provide further clinical information from the SIERRA study.