Actinium Engages CRO ACT Oncology For PHASE III Trials Of Iomab-B For Bone Marrow Transplantation
By Cyndi Root
Actinium Pharmaceuticals, Inc. announced in a press release that it has made an agreement with ACT Oncology, a contract research organization (CRO). ACT will provide management and supportive services in Actinium’s Phase III trials of Iomab-B, a myeloconditioning drug for bone marrow transplant preparation (in Relapsed and Refractory Acute Myeloid Leukemia), as well as services for other clinical development related projects. Actinium stated that it will submit regulatory documents for the effort to the Food and Drug Administration (FDA) by the end of 2014.
Kaushik J. Dave, Ph.D., MBA, Actinium’s President and CEO, said, “Based on our team’s previous experience working with ACT Oncology, we have been consistently impressed with their communication and project management systems which will be critical to the successful execution of our pivotal trial.” Patricia Devitt, Pharm. D., President of ACT Oncology, said, “This study holds great promise for the AML patient population and we look forward to leveraging ACT Oncology’s deep pool of talented clinical research professionals to make our collaboration with Actinium a success.”
Actinium and ACT Collaboration
Dr. Dave of Actinium stated that ACT Oncology has managed nearly 30 studies of hematological oncology and therefore has the skills and experience for its Phase III trials. Based in Flemington, New Jersey and Madrid, Spain, ACT is positioned for trials in the U.S. and abroad. ACT has agreed to support several oncology initiatives with Actinium. The two companies are currently finalizing the manufacturing plans and preparing regulatory materials for Iomab-B trials.
Iomab-B Trials
The two companies have been working with the FDA and transplant experts to develop the Phase III program. Actinium stated that FDA feedback indicated that a small trial of 150 patients is appropriate and that only one trial will be necessary, if successful, for a Biologics License Application (BLA) submission. The FDA agreed to this design due to Phase I/II trials that showed disease free survival at six months in 60 percent of the patients. The trial is to include older patients with relapsed and refractory acute myeloid leukemia (AML) over the age of 55. Investigators seek a primary endpoint of durable complete remission (dCR) rate of at least 180 days.