Full Press Release Details
Pharmaceuticals Presents Results of its Phase IIb Clinical Trial
Diabetes Technology Meeting 2010 in Bethesda, MD.
Israel -November 15, 2010 - Oramed Pharmaceuticals Inc. (OTCBB: ORMP.OB; www.oramed.com), a
developer of oral drug delivery systems, presented the results of its recently
completed Phase IIb trial. The multicenter, placebo-controlled, randomized,
double-blind study conducted in 29 patients with Type II diabetes assessed
the safety of ORMD-0801 in patients with Type II diabetes. Results
were presented by the company's Chief Scientific Officer, Dr. Miriam
Kidron, at the Tenth Annual Meeting of the Diabetes Technology Society, in
The poster presentation entitled "Extended exposure to an oral insulin
formulation yields decreased insulin secretion in Type II diabetes
subjects," described Oramed's first extended exposure
study to its oral insulin product (ORMD-0801), where 21 patients were treated with ORMD-0801, self-administered daily for a period of six
weeks. In parallel, a group of eight patients received placebo
capsules administered under the same treatment regimen. ORMD-0801 proved safe and tolerable,
with no reports of serious adverse events throughout the study. In
addition, no cumulative effects of extended ORMD-0801 exposure were noted, and
only two mild cases of transient hypoglycemia were
reported. Treatment efficacy was evaluated
via markers quantified from blood samples drawn at the start and end of the study. Daily
administration of oral
insulin led to a statistically significant decrease in both insulin and
C-reactive protein (CRP)
levels, in contrast to
placebo-treated individuals. Moreover, the percentage of subjects demonstrating clinically relevant reductions in
insulin, c-peptide, fasting blood glucose (FBG) and Hb1Ac levels was
consistently higher in the ORMD-0801 cohort, when compared to its placebo
counterpart. This study addressing, for the first time,
long-term safety concerns from extended ORMD-0801
demonstrated safety and no
serious adverse events were reported.
The poster can be viewed
Oramed Pharmaceuticals
Pharmaceuticals is a technology pioneer in the field of oral delivery solutions
for drugs and vaccines presently delivered via injection. Oramed is seeking
to revolutionize the treatment of diabetes through its patented flagship
product, an orally ingestible insulin capsule currently in Phase 2 clinical
trials. Established in 2006, Oramed's technology is based on over 25 years of
research performed by top research scientists at Jerusalem's Hadassah Medical
Center. The Company'orporate and R&D headquarters are based in
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Oramed Pharmaceuticals, Inc.
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