JERUSALEM, Jan. 30, 2014
/PRNewswire/ -- Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP),
a developer of oral drug delivery systems, announced today results
from its Phase 2a clinical trial for its ORMD-0801 oral insulin
capsule for the treatment of type 2 diabetes. The trial was
conducted under a United States Food and Drug Administration (FDA)
IND (Investigational New Drug) protocol. The Phase 2a study met all
primary and secondary endpoints.
30 patients with type 2 diabetes took part in the trial in an
in-patient setting for one week. Endpoints of safety as well
as pharmacodynamic and pharmacokinetic effects were evaluated
against a placebo control. For full information on the Phase
2a trial design and endpoints please see Clinical Trials*.
Further information on the safety results of the Phase 2a
clinical trial can be found on Oramed's website. Full results are
expected to be presented at a scientific conference in the
future.
"We are extremely pleased with the results which give a solid
validation for Oramed's platform technology in general and our oral
insulin program in particular," stated Oramed CEO Nadav Kidron. "Following on the results from
this type 2 diabetes study we are gearing up to start a
multi-center Phase 2b study later this year. We are also
excited about the potential of this drug for type 1 diabetes and
plan to initiate a Phase 2a FDA study for this indication in the
near term."
About ORMD-0801 Oral Insulin
Oramed's ORMD-0801 is an orally ingestible insulin capsule for
the early stages of type 2 diabetes, when it can still slow the
rate of degeneration of the disease by providing additional insulin
to the body and allowing pancreatic respite. Moreover, orally
administered insulin has the potential benefit of enhanced patient
compliance at this crucial stage as well as the advantage of
mimicking insulin's natural location and gradients in the body by
first passing through the liver before entering the bloodstream.
For more information on ORMD-0801, 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
(PODTM) technology is based on over 30 years of research
by top research scientists at Jerusalem's Hadassah
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 exenatide capsule (ORMD-0901; a
GLP-1 analog). 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 please visit
www.oramed.com*
* The content of which is not part of this press release
Forward-looking statements: This press release
contains forward-looking statements. For example, we are using
forward-looking statements when we discuss the results of our phase
2a clinical trial validating our technology platform and insulin
oral program, the future announcement of the full results of this
trial, our planned clinical trials, the potential of ORMD-0801 oral
insulin capsule for type 1 diabetes, or revolutionizing the
treatment of diabetes with our products. These
forward-looking statements and their implications 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 Sherman
Cell: +972-54-792-4438
Office: +972-2-566-0001
Email: aviva@oramed.com
SOURCE Oramed Pharmaceuticals Inc.