Medpace to run Ph III trial of blood cancer ADC for Actinium
Actinium announced the deal yesterday, explaining it selected the Cincinnati contract research organisation (CRO) based on experience in managing bone marrow transplantation programmes and its global reach.
Iomab-B is an antibody drug conjugate. The antibody that targets the CD45 antigen on hematopoietic cells and the linked iodine-131 radioisotope emits alpha particles that kill the cancerous cells.
The idea is that targeting in this way will reduce side effects and provide an option for patients with cancers that are resistant to beta particle based therapy.
Phase III trial
Under an agreement with the US Food and Drug Administration (FDA) the Phase III trial will be a two arm, randomized, controlled, multicenter study of Iomab-B in patients with refractory and relapsed Acute Myeloid Leukemia (AML) patients over the age of 55.
The vast majority of patients over the age of 50 are usually ineligible for radiotherapy, either as a result of associated conditions or because they have developed resistance to available radiotherapies.
Medpace has been tasked with recruiting 150 AML patients who will be treated with the antibody-based drug before receiving a bone marrow transplant.
Actinium contracted Florida-based contract manufacturing organisation (CMO) Goodwin Biotechnology to manufacture supplies of Iomab-B for the Phase III study in 2014.
Medpace is owned by private equity firm Cinven, which acuired the CRO in 2014 for $915m (€839m).
