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Last updated on April 18, 2014 at 15:29 EDT

Oramed Pharmaceuticals Reports Results in Phase 2b Trial of Oral Insulin Administration to Type 2 Diabetes Patients

May 6, 2010

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 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
the United States.”

For more information about Oramed’s clinical development programs, please
visit http://www.oramed.com.

Safe Harbor Statement

Some of the statements contained in this press release are
forward-looking statements which involve known and unknown risks,
uncertainties and other factors which may cause the actual results,
performance or achievements of the company, or industry results, to be
materially different from any future results, performance or achievements
expressed or implied by such forward looking statements, including the risks
and uncertainties related to the progress, timing, cost, and results of
clinical trials and product development programs; difficulties or delays in
obtaining regulatory approval for our product candidates; competition from
other pharmaceutical or biotechnology companies; and the company’s ability to
obtain additional funding required to conduct its research, development and
commercialization activities. Please refer to the company’s filings with the
Securities and Exchange Commission for a comprehensive list of risk factors
that could cause actual results, performance or achievements of the company
to differ materially from those expressed or implied in such forward looking
statements. The company undertakes no obligation to update or revise any
forward-looking statements.

    Company and Investor Relation Contacts:

    Oramed Pharmaceuticals
    Tara Horn
    Office: +1-646-240-4193
    Cell: +972-54-334-318
    Email: tara@oramed.com

SOURCE Oramed Pharmaceuticals Inc.


Source: newswire