Full Press Release Details
Pharmaceuticals Reports Results in Phase 2b Trial of Oral Insulin Administration
to Type 2 Diabetes Patients
Proves Safe and Tolerable in Type 2 Diabetes Subjects
Israel - May 6, 2010- 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,
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.
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
Jacob, M.D., a member of the Oramed Board of Directors, said, "the results of
this trial once again underscore the safety of Oramed's oral insulin
preparation. These results show a positive trend of efficacy for the tested oral
insulin preparation." Nadav Kidron, Chief Executive Officer of Oramed
Pharmaceuticals, added "this study, as well as data from our earlier studies,
suggests that Oramed's technology is an effective and well-tolerated delivery
platform that will potentially make a significant clinical impact on diabetes
management. We are proceeding with confidence toward IND approval in
information about Oramed's clinical development programs, please visit
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