JERUSALEM, Israel, May 6, 2010 OramedPharmaceuticals Inc. (OTCBB: ORMP), a developer of alternative drug deliverysystems, reported today results for the recently completed Phase 2b non-FDAclinical trial of its flagship oral insulin capsule, ORMD-0801.
The randomized, double-blind, placebo-controlled, multi-centered studyconducted in South Africa evaluated responses of 29 Type 2 diabetes patientsto ORMD-0801. Insulin-loaded or placebo capsules were administered topatients, who were closely monitored throughout the 6-week study period.Safety, tolerability and efficacy parameters of Oramed's oral insulin wereassessed.
ORMD-0801 was found to be well tolerated and exhibited a positive safetyprofile. No cumulative adverse effects were reported throughout this firststudy of extended exposure to ORMD-0801. In addition, the percentage ofsubjects demonstrating clinically relevant reductions in insulin, c-peptide,fasting blood glucose and Hb1Ac levels was always higher in the ORMD-0801cohort, when compared to the placebo. Moreover, mean decreases in insulin andCRP levels were found to be statistically significant following the 6-week,once-daily ORMD-0801 treatment period. These findings suggest that ORMD-0801attenuates insulin oversecretion, reprieving beta cells from their heightenedactivity. The reported results substantiate the safety and tolerability ofORMD-0801 and demonstrate that oral insulin has a relevant clinical impact atthe tested dose. The data collected from this trial will help to further thedevelopment of ORMD-0801 in future, pivotal trials.
Harold Jacob, M.D., a member of the Oramed Board of Directors, said, "theresults of this trial once again underscore the safety of Oramed's oralinsulin preparation. These results show a positive trend of efficacy for thetested oral insulin preparation." Nadav Kidron, Chief Executive Officer ofOramed Pharmaceuticals, added "this study, as well as data from our earlierstudies, suggests that Oramed's technology is an effective and well-tolerateddelivery platform that will potentially make a significant clinical impact ondiabetes management. We are proceeding with confidence toward IND approval inthe United States."
For more information about Oramed's clinical development programs, pleasevisit http://www.oramed.com.
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SOURCE Oramed Pharmaceuticals Inc.