HINCKLEY, Ohio, Nov. 19, 2014 /PRNewswire/ -- An African-led scientific team in collaboration with U.S.-based Clinical Research Management, Inc. (ClinicalRM), and the United States Army Medical Research Institute of Infectious Diseases (USAMRIID) today announced the assembly of the Global Emerging Pathogens Therapy/Treatment (GET) Consortium.
This group of medical and project management experts from all the geopolitical regions of Africa, Europe, Asia and the United States, is pooling resources to assess the efficacy of immune plasma collected from survivors of Ebola Virus Disease (EVD) in West Africa. The Consortium, whose plan is closely aligned with the WHO position paper on collection and use of convalescent plasma or serum as an element in Filovirus outbreak response, expects to begin clinical trials in November 2014. Members from the GET Consortium are also acting as key scientific advisors for the effort in West Africa related to convalescent plasma for the treatment of Ebola virus disease recently announced by the Bill & Melinda Gates Foundation.
"There is no known cure for Ebola but there is convincing evidence that the disease can be prevented and its severity curtailed by the use of plasma products from patients who have recovered," said Professor Akin Abayomi, a haematologist based in Tygerberg Academic Hospital, University of Stellenbosch and the National Health Laboratory Service of South Africa, and one of the founding members of the GET consortium. "The availability of new technology at our disposal provides an opportunity to study the effectiveness of Ebola convalescent plasma and could help contain the spread of this deadly pathogen more effectively"
The African-led effort is comprised of clinicians, haematologists, ethicists, medical and community engagement experts from academic research universities, research organizations and private industry. The GET Consortium is working at a rapid pace to organize and establish plasmapheresis and plasma processing and storage facilities in key strategic locations in Africa and to rapidly conduct clinical trials to assess efficacy in the affected areas.
The use of blood components has long been a challenge in countries like Africa due to blood borne infections such as HIV, hepatitis and malaria. However, pathogen inactivation technologies that substantially reduce the risk of transfusion transmittable infections from blood components provide an opportunity to safely study the potential of immune-plasma treatment in patients without placing them at risk for contracting other diseases. Requests for regulatory approvals in the U.S. and in West Africa are currently being sought and finalized.
The Consortium is collaborating with the Lagos State Government, Nigeria to establish one of its nerve centers in Lagos in the light of the success and leadership demonstrated in containing the outbreak in Nigeria. Regional trial centers will be established across the most affected countries in the West African region in this collaborative effort. The Consortium will define the natural history of Ebola more closely and provide solutions to the current outbreak that is affecting much of the sub region. The activity of GET Consortium and its partners in its endeavor to address this current outbreak, will ultimately result in much needed indigenous capacity development in the field of blood component therapy in Africa. The consortium is grateful that Dr. Jide Idris, Honorable Commissioner of Health for Lagos State, who catalyzed this initiative, has expressed the State Government's desire to host the headquarters of this highly important initiative in a planned facility that has been ear marked as a center of excellence for preparedness and early warning capabilities for emerging infectious diseases into the future. The Lagos State Government has also established an Ebola Research Core Group to facilitate this collaboration and partnership.
About the Global Emerging Pathogens Therapy/Treatment (GET) Consortium
The Global Emerging Pathogens Therapy/Treatment (GET) Consortium is comprised of over 40 African medical and logistics experts from diverse backgrounds, working with international collaborators with a goal of providing recommendations and establishing research that can be conducted now and in the near future to respond and prepare for Ebola and other emerging dangerous pathogen outbreaks.
Founded in 1994, ClinicalRM is a full-service CRO with headquarters in Ohio and specializes in preclinical through Phase IV support of clinical trial services for biologics, drugs, and devices. Through international partnerships and a global selection of sites, they support their customers with a wide array of research, regulatory, and sponsor services that are tailored to accommodate clinical trials globally. Spanning the government, academic, and commercial marketplaces, ClinicalRM's multi-therapeutic team consists of leading experts in the fields of Infectious Disease, Vaccine Development, and Neurotherapeutics. ClinicalRM's goal is simple—to assist in improving the quality of life in communities throughout the world by advancing the goals of their customers.
Christine Cassiano/Andrea Rothschild