Actinium announces activation of sixteenth clinical trial site in Iomab-B trial
Actinium Pharmaceuticals announced that the Company has successfully activated sixteen clinical trial sites in the pivotal Phase 3 SIERRA trial. The SIERRA trial is planned to enroll 150 patients with relapsed or refractory acute myeloid leukemia who are age 55 and above and will compare Iomab-B and a BMT to physician's choice of salvage chemotherapy. The primary endpoint is durable complete remission of at least six months. Iomab-B is intended to provide safer myeloablation of the bone marrow prior to a bone marrow transplant, thus providing a potentially curative treatment option for this patient population and for patients with other leukemias, lymphomas, myelomas and other blood disorders. With Stony Brook, New York-based Stony Book University, the sixteen clinical trial sites in the Phase 3 SIERRA trial represent over one-third of bone marrow transplant volume in the U.S., which bodes well for reaching the 150-patient enrollment goal. Actinium also announced that it expects to provide updates on the Iomab-B SIERRA trial in line with previously stated objectives for 2018 and 2019. The SIERRA trial will have three safety analyses by an independent Data Monitoring Committee when 25%, 50% and 75% patient enrollment has been reached. Also, two ad-hoc efficacy analyses may be requested by Actinium after 70 and/or 110 patients have engrafted and given enough time to achieve the primary endpoint of durable complete remission at six months post-treatment.