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HHS to work with ZMapp manufacturers to develop Ebola drug

The development of a medication to treat illness from Ebola will be accelerated under a contract with the U.S. Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response, according to a news release.

ASPR’s Biomedical Advanced Research and Development Authority will provide funding through a $24.9 million, 18-month contract with Mapp Biopharmaceutical Inc., in San Diego. ASPR can extend the contract up to a total of $42.3 million.

Work under the contract supports the development and manufacturing of the medication ZMapp toward the goal of U.S. Food and Drug Administration approval, according to the release.

“While ZMapp has received a lot of attention, it is one of several treatments under development for Ebola, and we still have very limited data on its safety and efficacy,” Nicole Lurie, MD, assistant secretary for preparedness and response, said in the release. “Developing drugs and vaccines to protect against Ebola as a biological threat has been a long-term goal of the U.S. government, and today’s agreement represents an important step forward.”

BARDA will work closely with the Defense Threat Reduction Agency and the National Institute of Allergy and Infectious Diseases to speed the development of ZMapp.
As part of the project funded, Mapp Biopharmaceutical will manufacture a small amount of the drug for early-stage clinical safety studies and nonclinical studies needed to demonstrate the drug’s safety and efficacy in people, according to the release.

ZMapp is a combination of three monoclonal antibodies, manufactured in tobacco plants, which bind virus proteins and neutralize the virus, decreasing the amount of the virus in the body that the patient’s immune system has to fight, according to the release. ZMapp has been shown to reduce mortality in mice and nonhuman primates exposed to Ebola viruses.

BARDA is seeking additional proposals for the advanced development of antibody treatments, antiviral drugs, and vaccines against the Ebola and Marburg viruses, both of which cause viral hemorrhagic fever.

By | 2014-09-05T00:00:00-04:00 September 5th, 2014|Categories: National|0 Comments

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