JERUSALEM, Israel, May 6, 2010 /PRNewswire-FirstCall/ -- Oramed Pharmaceuticals Inc. (OTCBB: ORMP), a developer of alternative drug delivery systems, reported today results for the recently completed Phase 2b non-FDA clinical trial of its flagship oral insulin capsule, ORMD-0801.
The randomized, double-blind, placebo-controlled, multi-centered study conducted in South Africa evaluated responses of 29 Type 2 diabetes patients to ORMD-0801. Insulin-loaded or placebo capsules were administered to patients, who were closely monitored throughout the 6-week study period. Safety, tolerability and efficacy parameters of Oramed's oral insulin were assessed.
ORMD-0801 was found to be well tolerated and exhibited a positive safety profile. No cumulative adverse effects were reported throughout this first study of extended exposure to ORMD-0801. In addition, the percentage of subjects demonstrating clinically relevant reductions in insulin, c-peptide, fasting blood glucose and Hb1Ac levels was always higher in the ORMD-0801 cohort, when compared to the placebo. Moreover, mean decreases in insulin and CRP levels were found to be statistically significant following the 6-week, once-daily ORMD-0801 treatment period. These findings suggest that ORMD-0801 attenuates insulin oversecretion, reprieving beta cells from their heightened activity. The reported results substantiate the safety and tolerability of ORMD-0801 and demonstrate that oral insulin has a relevant clinical impact at the tested dose. The data collected from this trial will help to further the development of ORMD-0801 in future, pivotal trials.
Harold Jacob, M.D., a member of the Oramed Board of Directors, said, "the
results of this trial once again under
|SOURCE Oramed Pharmaceuticals Inc.|
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