Andromeda Announces That Further Data Analyses Support Primary Endpoint in Andromeda Biotech's Phase III Clinical Study

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).  

Secondary and exploratory endpoints demonstrate:

1. A greater proportion of DiaPep277^® treated patients maintained good diabetic control compared to the placebo, measured by HbA1c levels equal or less than 7% at the end of the study (p<0.05).
2. A greater proportion of DiaPep277^® treated patients required lower doses of insulin at the end of the study compared with placebo (p<0.05).
3. DiaPep277^®  treated patients who complied with the study protocol experienced a lower rate of hypoglycemic events compared with placebo (p<0.05).
4. A greater proportion of DiaPep277^® treated patients who complied with the study protocol maintained good diabetic control while using lower doses of insulin (HbA1c levels equal or less than 7% and insulin dose equal or less than 0.5 IU/Kg/day) (p<0.05).

Other secondary endpoints (fasting C-peptide, stimulated C-peptide by a mixed meal) did not show a statistically significant difference between the groups.

The drug demonstrates a good safety profile since no major differences in drug-related adverse events were reported between the two groups.

Andromeda expects the final analyses of the study results by the end of Q2 2012.

The results reported above will be presented at a number of international scientific meetings:

1. 8^th International Congress of Autoimmunity in Granada, Spain, May 9-13, 2012
2. American Diabetes Association (ADA) 72^nd Scientific Sessions in Philadelphia, PA, USA, June 8-12, 2012
3. IDS Victoria 2012 - 12th International Conference on the Immunology of Diabetes, June 15-19, 2012