Oramed Pharmaceuticals Announces First Patient Enrolled in a US Phase 2a Trial for ORMD-0801 in Treatment of Type 1 Diabetes

Oramed Pharmaceuticals Announces First Patient Enrolled in a US Phase 2a Trial
                for ORMD-0801 in Treatment of Type 1 Diabetes

PR Newswire

JERUSALEM, March 27, 2014

JERUSALEM, March 27, 2014 /PRNewswire/ --

Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (http://www.oramed.com), a
clinical-stage pharmaceutical company focused on the development of oral drug
delivery systems, announced today that the first patient has been enrolled in
its U.S. Phase 2a trial for its orally ingestible insulin capsule, ORMD-0801,
in the treatment of type 1 diabetes (T1DM).

"We are pleased to be initiating this U.S. clinical trial with ORMD-0801 in
patients with type 1 diabetes following successful trials outside of the US,"
said Nadav Kidron, CEO of Oramed Pharmaceuticals. "This initiation is in
parallel to the company gearing up for its multi-center Phase IIb study for
the treatment of type 2 diabetics."

This Phase 2a clinical trial is a prospective, randomized, double-blind,
placebo-controlled study designed to enroll up to 24 patients with type 1
diabetes in-clinic for 10 days. Patients will be randomized in a 2:1 ratio to
receive either ORMD-0801 or placebo. The primary endpoint of the trial is to
evaluate the change from baseline in exogenous insulin requirements (basal,
bolus, and total) in patients treated with ORMD-0801, compared to the change
from baseline for patients treated with placebo. Secondary endpoints include
evaluating the change from baseline in mean nighttime, daytime, and fasting
glucose levels in type 1 diabetes patients treated with ORMD-0801, compared to
the change from baseline for patients treated with placebo. For more details
on the trial, please visit http://www.clinicaltrials.gov.

About ORMD-0801 Oral Insulin and T1DM

Oramed proposes to introduce ORMD-0801 to reduce the mealtime insulin doses,
introducing a treatment regimen which would allow for fewer daily injections.
Moreover, oral administration offers the benefit of reduced systemic exposure
and may enable tighter regulation of blood sugar levels by directly affecting
glucose control in the liver. For more information on ORMD-0801, the content
of which is not part of this press release, please visit
http://oramed.com/index.php?page=14

About Oramed Pharmaceuticals

Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery
solutions for drugs and vaccines currently delivered via injection.
Established in 2006, Oramed's Protein Oral Delivery (POD™) technology is based
on over 30 years of research by top research scientists
atJerusalem'sHadassah Medical Center. Oramed is seeking to revolutionize the
treatment of diabetes through its proprietary flagship product, an orally
ingestible insulin capsule (ORMD-0801) currently in Phase 2 clinical trials on
patients with type 2 diabetes (T2DM) under an Investigational New Drug
application with the U.S. Food and Drug Administration, and with its oral
GLP-1 analog capsule (ORMD-0901). Oramed is also moving forward with clinical
trials of ORMD-0801 for the treatment of type 1 diabetes. The company's
corporate and R&D headquarters are based in Jerusalem.

For more information, the content of which is not part of this press release,
please visithttp://www.oramed.com

Forward-looking statements: This press release contains forward-looking
statements within the meaning of the Private Securities Litigation Reform Act
of 1995 and other federal securities laws. Words such as "expects,"
"anticipates," "intends," "plans," "believes," "seeks," "estimates" and
similar expressions or variations of such words are intended to identify
forward-looking statements. For example, we are using forward-looking
statements when we discuss our clinical trials, including the expected design
and timing, the goal of [introducing ORMD-0801], and revolutionizing the
treatment of diabetes with our products. These forward-looking statements are
based on the current expectations of the management of Oramed only, and are
subject to a number of factors and uncertainties that could cause actual
results to differ materially from those described in the 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 or patent protection
for our product candidates; competition from other pharmaceutical or
biotechnology companies; and our ability to obtain additional funding required
to conduct our research, development and commercialization activities. In
addition, the following factors, among others, could cause actual results to
differ materially from those described in the forward-looking statements:
changes in technology and market requirements; delays or obstacles in
launching our clinical trials; changes in legislation; inability to timely
develop and introduce new technologies, products and applications; lack of
validation of our technology as we progress further and lack of acceptance of
our methods by the scientific community; inability to retain or attract key
employees whose knowledge is essential to the development of our products;
unforeseen scientific difficulties that may develop with our process; greater
cost of final product than anticipated; loss of market share and pressure on
pricing resulting from competition; laboratory results that do not translate
to equally good results in real settings; our patents may not be sufficient;
and final that products may harm recipients, all of which could cause the
actual results or performance of Oramed to differ materially from those
contemplated in such forward-looking statements. Except as otherwise required
by law, Oramed undertakes no obligation to publicly release any revisions to
these forward-looking statements to reflect events or circumstances after the
date hereof or to reflect the occurrence of unanticipated events. For a more
detailed description of the risks and uncertainties affecting Oramed,
reference is made to Oramed's reports filed from time to time with the
Securities and Exchange Commission.

Company Contact:

Oramed Pharmaceuticals      
Aviva Guiloff        
Office: +972-2-566-0001 ext. 2
US: +1-718-831-2512 ext. 2
Email: aviva@oramed.com

US Investor Relations Contact:

LifeSci Advisors LLC
Michael Rice
US: +1-646-597-6979
Email: mrice@lifesciadvisors.com



SOURCE Oramed Pharmaceuticals Inc.
 
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