Clal Biotechnology Industries Release: Andromeda Announces That Further Data Analyses Support Primary Endpoint in Andromeda Biotech's Phase III Clinical Study
Published: May 10, 2012
YAVNE, Israel, May 9, 2012 (GLOBE NEWSWIRE) -- Clal Biotechnology Industries Ltd. today announces that further analyses of initial data support the achieved primary endpoint of Andromeda Biotech's pivotal phase III clinical study. The 24-month trial was a randomized, placebo-controlled, designed to assess the safety and efficacy of DiaPep277®, a novel immunotherapeutic agent for the treatment of newly diagnosed patients with Type 1 Diabetes (T1D). Initial data demonstrated that the primary endpoint, defined as the change from baseline in C-peptide levels at the end of the study as measured by GST, was met. A significant difference in preservation of C-peptide levels was demonstrated in the DiaPep277® treated arm when compared to the placebo arm reflecting a relative preservation of the pancreas ability to secrete insulin of 23.4% (p<0.05).