Sunday, December 14, 2014 12:59:15 AM
Ebola Therapeutics Development. Additionally, the U.S. Government is supporting the development of several investigational candidate therapeutics to treat patients infected with the disease. Some have already been employed in patients in the United States and Africa.
ZMapp: Under contract with DOD’s Defense Threat Reduction Agency (DTRA) and BARDA, ZMapp’s antibodies are produced in specially grown tobacco plants and have only been produced in limited quantities. BARDA is sponsoring the manufacturing of ZMapp for Phase 1-2 clinical studies. ZMapp has shown evidence of antiviral activity in animal models of infection. Clinical studies are expected to start in early 2015 at NIAID. Other clinical studies are slated to begin in affected African countries in early 2015. This therapeutic candidate has been used under an emergency investigational new drug (eIND) application in Ebola-infected patients in the United States, Africa, and elsewhere. Mapp Biopharmaceutical produces ZMapp.
TKM-Ebola: TKM-Ebola has undergone testing in nonhuman primates and showed a significant benefit in terms of survival. This therapeutic candidate has been used under an eIND in some Ebola-infected patients in the United States. Plans for studying this drug in clinical trials are under discussion. TKM-Ebola is produced by the Canadian company Tekmira Inc. under a contract from DTRA.
BCX4430: BCX4430 is a small molecule drug with recent NIH support that, in preliminary investigations, has been reported to have some antiviral activity against a range of viruses, including Ebola. NIH and the U.S. Army Medical Research Institute of Infectious Diseases are collaborating to evaluate activity in nonhuman primate models of Ebola virus disease as well as human clinical safety trials. Potential for clinical trials has been under discussion depending on assessment of animal study results.
Brincidofovir (CMX001): Brincidofovir, originally supported by BARDA as a potential smallpox drug, was reported in one study to show possible inhibition of Ebola virus replication in infected cells. This therapeutic candidate has been used under an eIND in some Ebola-infected patients in the United States. Potential for clinical trials has been under discussion depending on assessment of animal study results. The drug is under development by Chimerix.
Favipiravir (T-705): Favipiravir has been in clinical trials for treatment of influenza but also been reported to show some activity against other viruses, including in Ebola-infected cells. This therapeutic candidate was developed by Toyama and is licensed to Fujifilm and Medivector with support from DTRA. Potential for clinical trials has been under discussion, and it has reportedly been used in some Ebola-infected patients in Europe.
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