Actinium Pharmaceuticals Inc. announced this week that its choice for Clinical Research Organization (CRO) that will conduct its Phase 3 Iomab-B clinical trial is Medpace.
As a CRO, Medpace offers Phase 1-4 drug, biologic and device development service programs.
Actinium chose Medpace for its Phase 3 Iomab-B clinical trial because of Medpace’s knowledge and expertise when it comes to conducting and managing clinical trials in the bone marrow transplant field. With the partnership in place, Actinium can now move on to launching clinical sites and enrolling patients for the study of Iomab-B.
Iomab-B is a radioimmunoconjugate that contains BC8, an antibody that is monoclonal. Iomab-B was developed to target CD45, which is a pan-leukocytic antigen generally found on white blood cells. With BC8 targeting CD45, this makes Iomab-B potentially useful in preparation for hematopoietic stem cell transplants.
The Phase 3 trial of Iomab-B will be administered to patients over the age of 55 who have relapsed or refractory Acute Myeloid Leukemia (AML). The primary goal of the trial is to discover if Iomab-B can achieve complete remission for at least six months. The secondary goal is to see whether patients survive one year.