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The Lancet Publishes Data from Protege, MacroGenics' Phase 3 Clinical Study of Teplizumab in Type 1 Diabetes Patients
Date:6/28/2011

1-year results from a randomized, placebo-controlled trial," by Sherry, et al.(1) and provides the results of per protocol as well as exploratory, post hoc analyses.  The findings suggest that "future studies of immunotherapeutic intervention with teplizumab might have increased success in prevention of a decline in beta-cell function (measured by C-peptide) and provision of glycaemic control at reduced doses of insulin if they target patients early after diagnosis of diabetes and children."

The article indicates that teplizumab treatment may preserve beta cell function as measured by C-peptide, allowing less insulin use to achieve the same glycemic control as patients receiving placebo. A greater proportion of patients in the teplizumab groups were able to discontinue or use very low doses of insulin compared to the placebo group.  A reduced insulin requirement while maintaining glycemic control appears to support teplizumab having a biological effect.

In the safety analyses, the proportion of patients who had adverse events and serious adverse events was similar across the four study groups.  Rash was the most common clinical adverse event reported more frequently with teplizumab than placebo. Mild cytokine release syndrome was infrequent but greater in treatment groups compared to placebo. The safety profile was characterized by transient increases in some liver function test results and transient decreases in white cells that prevent infections. However, no increase in overall infections was seen.

"We are very pleased to have teplizumab Phase 3 data published in this prestigious journal," stated Dr. Scott Koenig, President and CEO of MacroGenics.  "Although the Protege study missed its primary endpoint, the data appear to indicate that teplizumab has a desired biological effect in certain subpopulations with a potentially meaningful therapeutic benefit for patients with recent-onset type 1 diabetes.  These groups in
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SOURCE MacroGenics, Inc.
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