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MacroGenics Begins Global Phase 2/3 Protege Study in Recent-onset Type 1 Diabetes Mellitus
Date:8/19/2007

Three Independent Clinical Trials Initiated with Teplizumab Manufactured at

MacroGenics

ROCKVILLE, Md., Aug. 2 /PRNewswire/ -- MacroGenics, Inc. announced today that its Protege trial is actively enrolling adults and children ages 8 to 35 with recent-onset type 1 diabetes. The global Phase 2/3 clinical trial will evaluate the safety and efficacy of three teplizumab dosing regimens administered at the start of the study and again at six months in individuals who are up to 12 weeks from their diagnosis of type 1 diabetes. "The initiation of the pivotal Protege study is an important milestone for MacroGenics and for the type 1 diabetes research community," stated Dr. Scott Koenig, President and CEO of MacroGenics. "It is also notable that teplizumab is the first CD3 monoclonal therapy targeting type 1 diabetes to reach this stage of clinical development."

Specifically, the Protege study will assess the ability of teplizumab to inhibit the autoimmune attack that destroys insulin-producing pancreatic beta cells in individuals with type 1 diabetes. If teplizumab is effective and has the ability to preserve or protect beta cells of the pancreas, patients may require less injected insulin and their blood glucose levels may be easier to control. Other research has shown that greater control of blood glucose levels can lead to better long-term health outcomes for patients with type 1 diabetes.

Dr. Koenig also commented, "We are pleased to announce that Dr. Kevan Herold of Yale University and Dr. Bernhard Hering of the University of Minnesota are leading additional teplizumab studies in type 1 diabetes." The AbATE and Delay studies, led by Dr. Herold, are evaluating the safety and efficacy of teplizumab in patients who have had the disease for up to one year. Dr. Hering is evaluating the use of teplizumab as an induction therapy in pancreatic islet cell transplantation.

Additional information regarding the studies i
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SOURCE MacroGenics, Inc.

Copyright©2007 PR Newswire.

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