information: Clinical trial authorisation
Announcement: clinical trial authorization
Company: Actinium Pharmaceuticals (USA - NJ)
- monoclonal antibody/radioimmunotherapy. Iomab-B (BC8-I-131 construct) is a radioimmunotherapy comprised of the monoclonal antibody BC8 coupled with the radioisotope Iodine-131 that is designed to deliver targeted payloads to cells that express CD45, a pan-leukemic antigen expressed on white blood cells and stem cells. Once attached to its target cells, the radioisotope, I-131, emits energy that travels a relatively long distance, destroying a patient's cancer cells and bone marrow.
- Iomab-B is intended to prepare and condition patients for a hematopoietic stem cell transplant, which is often considered the only potential cure for patients with certain blood-borne cancers and blood disorders.
Disease: acute myeloid leukemia (AML)
area: Cancer - Oncology
Country: Canada, USA
details: The SIERRA (Study of Iomab-B in Elderly Relapsed or Refractory AML) trial is a multi-center, randomized, controlled pivotal Phase 3 study of Iomab-B in patients with relapsed or refractory acute myeloid leukemia (AML) who are over the age of 55. Actinium Pharmaceuticals has established an agreement with the FDA that the path to a Biologics License Application (BLA) submission could include the SIERRA trial, if it is successful. The primary endpoint in the pivotal Phase 3 trial is durable complete remission, defined as a complete remission lasting at least 6 months and the secondary endpoint will be overall survival at one year.The primary objective of this study is to demonstrate the efficacy of Iomab-B, in conjunction with a Reduced Intensity Conditioning (RIC) regimen and protocol-specified allogeneic hematopoietic stem cell transplant (HCT), versus Conventional Care. (NCT02665065)
- • On May 10, 2017, Actinium Pharmaceuticals announced that the company received clearance from Health Canada to initiate the pivotal Phase 3 SIERRA Trial of Iomab-B at Canadian based clinical trial sites. The SIERRA trial is a 150-patient, randomized, multicenter pivotal study evaluating Iomab-B followed by an HSCT in patients with relapsed or refractory acute myeloid leukemia who are age 55 and above compared to physician’s choice of chemotherapy that patient’s in the control arm will receive. According to the Canadian Blood and Marrow Transplant Group (CBMTG), there are approximately 15 centers in Canada that perform blood and marrow transplants who participate in the CBMTG’s registry. In CBMTG’s 2015/2016 annual report, it reported that there were 7,693 allogeneic transplants performed in Canada including 2,417 for patients with AML.
- • On March 21, 2017, Actinium Pharmaceuticals announced that the company has received positive Scientific Advice from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) related to the EU approval pathway for Iomab-B. In its correspondence to Actinium, the EMA commented that the trial design, primary endpoint and planned statistical analysis of the U.S. pivotal Phase 3 SIERRA trial are acceptable and can serve as the basis for submission of a Marketing Authorization Application. In addition, the EMA commented that it does not anticipate the need for further standalone preclinical toxicology or safety studies.
- • On June 29, 2016, Actinium Pharmaceuticals announced that the pivotal Phase 3 clinical trial for Iomab-B has been initiated. Iomab-B, the Company's lead asset, upon approval, is intended to be an induction and conditioning agent used to prepare patients with relapsed or refractory acute myeloid leukemia who are over the age of 55 for a hematopoietic stem cell transplant. The SIERRA trial will include independent Data Monitoring Committee (DMC) reports, which will occur at 25, 50, 75 and 100 percent patient enrollment with the potential for two additional ad-hoc DMC reports. Approximately 150 medical centers provide AML bone marrow transplants, with the top 30 centers performing over 50 percent of the AML BMT procedures. Actinium expects many of the highest volume BMT centers to participate in the SIERRA trial given that the results of previous studies in almost 300 patients have demonstrated the potential of Iomab-B to create a new treatment paradigm for bone marrow transplants by: expanding the pool to ineligible patients who do not have any viable treatment options currently; enabling a shorter and safer preparatory interval for HSCT; reducing post-transplant complications; and showing a clear survival benefit including curative potential.