Emergent BioSolutions announced that the Phase I clinical trial for its anthrax monoclonal antibody therapeutic has commenced with the dosing of the first subject
ROCKVILLE, MD, USA | September 8, 2010 | Emergent BioSolutions Inc. (NYSE:EBS – News) announced today that the Phase I clinical trial for its anthrax monoclonal antibody therapeutic has commenced with the dosing of the first subject. Emergent’s fully human monoclonal antibody product candidate is being developed as a parenteral post-exposure therapeutic to treat symptoms of inhalational anthrax disease. The Phase I clinical trial, involving 50 healthy volunteers, is a randomized, double-blind, placebo-controlled, dose escalation study designed to evaluate the safety and pharmacokinetics of the monoclonal antibody candidate.
“Emergent is excited about the continued progress of its anthrax monoclonal antibody therapeutic,” said Stephen Lockhart, MRCP, senior vice president product development of Emergent BioSolutions. “This milestone reaffirms Emergent’s commitment to leading the development of medical countermeasures that address inhalational anthrax as a biological threat.”
Emergent received clearance of its Investigational New Drug application from the U.S. Food and Drug Administration to proceed with this Phase I clinical trial in May of this year.
This study is being funded by the Biomedical Advance Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (HHS), under contract No. HHSN272200800040C.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia. Additional information may be found at www.emergentbiosolutions.com.
SOURCE: Emergent BioSolutions Inc.
Post Views: 48
Emergent BioSolutions announced that the Phase I clinical trial for its anthrax monoclonal antibody therapeutic has commenced with the dosing of the first subject
ROCKVILLE, MD, USA | September 8, 2010 | Emergent BioSolutions Inc. (NYSE:EBS – News) announced today that the Phase I clinical trial for its anthrax monoclonal antibody therapeutic has commenced with the dosing of the first subject. Emergent’s fully human monoclonal antibody product candidate is being developed as a parenteral post-exposure therapeutic to treat symptoms of inhalational anthrax disease. The Phase I clinical trial, involving 50 healthy volunteers, is a randomized, double-blind, placebo-controlled, dose escalation study designed to evaluate the safety and pharmacokinetics of the monoclonal antibody candidate.
“Emergent is excited about the continued progress of its anthrax monoclonal antibody therapeutic,” said Stephen Lockhart, MRCP, senior vice president product development of Emergent BioSolutions. “This milestone reaffirms Emergent’s commitment to leading the development of medical countermeasures that address inhalational anthrax as a biological threat.”
Emergent received clearance of its Investigational New Drug application from the U.S. Food and Drug Administration to proceed with this Phase I clinical trial in May of this year.
This study is being funded by the Biomedical Advance Research and Development Authority (BARDA) and the National Institute of Allergy and Infectious Diseases (NIAID), National Institutes of Health (NIH), Department of Health and Human Services (HHS), under contract No. HHSN272200800040C.
About Emergent BioSolutions Inc.
Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease. Emergent’s marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Emergent’s product pipeline targets infectious diseases and includes programs focused on anthrax, tuberculosis, typhoid, flu and chlamydia. Additional information may be found at www.emergentbiosolutions.com.
SOURCE: Emergent BioSolutions Inc.
Post Views: 48
