FDAnews
www.fdanews.com/articles/96797-macrogenics-begins-phase-ii-iii-prot-eacute-g-eacute-study

Macrogenics Begins Phase II/III Protégé Study

August 6, 2007

MacroGenics announced that its Protégé trial is enrolling patients ages 8 to 35 with recent-onset Type 1 diabetes.

According to Macrogenics, the global Phase II/III 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.

The company added that test subjects will be individuals who have received their diagnosis within the past 12 weeks.

The 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, the company added.