Oramed Pharmaceuticals Reports Results in Phase 2b Trial of Oral Insulin Administration to Type 2 Diabetes Patients
ORMD-0801 Proves Safe and Tolerable in Type 2 Diabetes Subjects
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.
Company and Investor Relation Contacts: Oramed Pharmaceuticals,
Tara Horn, Office: +1-646-240-4193, Cell: + 972-54-334-318, Email:
tara@oramed.com .
Posted: May 2010
