- Actinium Pharmaceuticals ( NYSE: ATNM ), a biotech focused on targeted radiotherapies, jumped ~23% pre-market Monday after announcing that its lead product candidate Iomab-B met the primary endpoint in a pivotal Phase 3 trial involving patients with acute myeloid leukemia (AML).
- The multi-center clinical trial SIERRA was designed to compare Iomab-B as a conditioning regimen against a control arm before a bone marrow transplant (BMT) in 153 relapsed/ refractory AML patients aged 55 years of age or older.
- Per the topline results, the SIERRA trial met the main goal as those who received Iomab-B indicated six months of durable complete remission after the initial remission compared to the control arm (p<0.0001).
- Chief Executive Sandesh Seth said the company expects to release additional clinical data from the trial by the year-end.
- “We will continue to work on our Biologics License Application (BLA) submission to the US Food and Drug Administration (FDA) for approval of Iomab-B,” Actinium’s ( ATNM ) Dr. Avinash Desai remarked.
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Actinium climbs 23% as lead asset meets main goal in Phase 3 leukemia trial