Actinium Pharmaceuticals Inc (NYSEAMERICAN:ATNM) today announced that it has dosed the 38th patient in its pivotal Phase 3 SIERRA study of its drug Iomab-B in elderly patients with relapsed or refractory acute myeloid leukemia and reached 25% of its goal of patient enrollment.
As a result, the trial’s independent data monitoring committee will review the data from the trial at its next meeting in August.
The SIERRA trial aims to evaluate Iomab-B versus salvage chemotherapy as a bone marrow conditioning regimen for bone marrow transplants in patients who are older than 55 and are sick with relapsed or refractory acute myeloid leukemia.
“Patients with active relapsed or refractory AML, particularly older patients, have limited treatment options, poor survival prognoses and few successfully receive a bone marrow transplant," said Dr. Mark Berger, Actinium's chief medical officer. "We believe Iomab-B has the potential to significantly improve outcomes for these patients and we are optimistic that the SIERRA trial will support approval in an indication with significant unmet needs."
SIERRA is a 150 patient, randomized and controlled multi-center trial that is currently open at 16 leading bone marrow transplant centers in the US. Additional clinical trial sites are expected to be added in Europe, the US and Canada.
Jason McCarthy, an analyst with Maxim Group, is keeping a Buy rating and a US$3 price target on the stock. “As management continues to execute on its clinical strategy, we expect the company’s valuation to steadily rise.”
The completion of enrollment for SIERRA is expected by the close of this year and any clinical data is likely to come in the second half of next year.
Actinium Pharmaceuticals Inc shares are flat today at US$0.24.