Andromeda Announces Phase III Clinical Study With DiaPep277(R), a Novel Immunotherapeutic Agent for Type 1 Diabetes, Met Primary Endpoint
Published: Nov 22, 2011
YAVNE, Israel, Nov. 22, 2011 (GLOBE NEWSWIRE) -- Andromeda Biotech Ltd. announces initial results from a pivotal phase III clinical study. The 24-month study was randomized, placebo-controlled, designed to assess the safety and efficacy of DiaPep277(R), a novel immunotherapeutic agent for the treatment of newly diagnosed patients with Type 1 Diabetes (T1D). The results from patients who were treated with DiaPep277(R) show that the study has met its primary endpoint, defined as the change from baseline in C-peptide levels at the end of the study. Significant preservation of C-peptide levels, a marker for assessing endogenous insulin secretion by pancreatic cells, was demonstrated in patients treated with DiaPep277(R) compared to the placebo arm. The decline in C-peptide levels was more pronounced in the placebo arm than in the treated group. The difference between the arms reached 0.949 nmol/L/20 minutes, (p=0.0374). This difference reflects a relative preservation of 23.4% compared to placebo. Evaluation of the primary endpoint was performed on patients in the modified ITT population who have at least one measurement post baseline.