ClinicalRM will again deploy its boots-on-the-ground approach to fighting Ebola Virus Disease (EVD) with an expanded access protocol for ZMapp, an investigational treatment for EVD, in Africa and the U.S.
ClinicalRM will perform as subcontractor under federally funded Contract No. HHSO100201600021C, awarded to Mapp Biopharmaceutical by the Biomedical Advanced Research and Development Authority (BARDA), Office of the Assistant Secretary for Preparedness and Response, Office of the Secretary, Department of Health and Human Services, to assist in carrying out an expanded access protocol for ZMapp, a cocktail of three monoclonal antibodies being developed by Mapp/LeafBio to treat EVD.
This award is the latest instance of government and industry calling for ClinicalRM’s expertise in combating global health crises. The ZMapp protocol will take place in some of the historically hardest-hit areas for EVD—Sierra Leone, Liberia and Guinea—as well as at least three sites in the U.S. ClinicalRM’s tasks include training staff at study sites, monitoring the safety of study participants and managing the safe storage and shipping of the experimental product, particularly during periods when there are no EVD-positive patients. ClinicalRM’s Global Infrastructure Development (GID) group will ensure the capabilities of the African sites to perform the work and may make necessary infrastructure, laboratory, technology and operational improvements. The study may require ClinicalRM to mobilize rapid-response treatment units, working in the field to administer ZMapp to patients in situations where EVD cases occur in remote areas.
“Our involvement in this study is an acknowledgement of the expertise we gained during the 2014 outbreak working with EVD and the research environment in West Africa,” ClinicalRM President Joseph Sgherza said. “Our GID group’s motto—and goal—is ‘Leave Something Behind.’ We didn’t simply bring in bloodmobiles and staff as a temporary fix until the crisis was over—we stayed to build a sustainable structure of labs, supply chains, communications systems and highly trained clinicians that can now support research projects from sponsors around the world.”
As therapeutic options for EVD are extremely limited, potent agents to treat patients with EVD are needed. Of the experimental agents that have demonstrated survival benefit in non-human primate models, ZMapp is one of the most promising therapeutic interventions developed to date.