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MacroGenics Announces the Initiation of a Phase 2 Clinical Trial to Evaluate the Safety and Efficacy of Monoclonal Antibody MGAWN1 in Subjects with Suspected Central Nervous System Infection Due to West Nile Virus
Date:7/13/2009

ROCKVILLE, Md., July 13 /PRNewswire/ -- MacroGenics, Inc. today announced the initiation of the PARADIGM trial, a Phase 2 clinical study evaluating MGAWN1, a humanized monoclonal antibody, for the treatment of individuals with suspected central nervous system infection due to West Nile Virus (WNV). MacroGenics, a privately held biotechnology company that develops immunotherapeutics to treat autoimmune disorders, cancer and infectious diseases, was awarded a $50 million contract in September 2006 from the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, to support the development of MGAWN1.

The PARADIGM trial is a randomized, double-blind, multicenter, placebo-controlled study that is designed to evaluate the safety and efficacy of MGAWN1 in patients greater than or equal to 18 years of age with signs and symptoms of acute West Nile Neuroinvasive Disease. Approximately 20 sites in North America will be utilized for the conduct of the PARADIGM trial. For more information on the PARADIGM trial, please see www.clinicaltrials.gov.

MacroGenics also announced today the completion ofa Phase 1 study of MGAWN1 in healthy volunteers, with the last patient having completed treatment in late 2008. This randomized, double-blind, dose-escalation cohort study was designed to evaluate the safety, tolerability, and pharmacokinetics of a single infusion of MGAWN1 in healthy adults. The study demonstrated the drug to be safe and well tolerated at all doses tested.

"We are delighted with the initiation of the PARADIGM trial as well as the completion of the Phase 1 trial," stated Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. "Currently, there are no approved treatments for individuals with severe West Nile Virus infection. These patients are hospitalized and receive
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SOURCE MacroGenics, Inc.
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