JERUSALEM, November 12, 2013 /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 last patient has left the clinic from its U.S. FDA
Phase 2a safety study for ORMD-0801, an oral insulin capsule based
on the Company's platform Protein Oral Delivery (PODâ„¢)
technology.
The Phase 2a trial, which enlisted 30 type 2 diabetes patients
in an in-clinic setting for a seven-day period, was implemented in
response to FDA feedback requesting a safety study on ORMD-0801
prior to initiating a larger multi-center trial in the US.
"We are thrilled to announce the last patient out of our Phase
2a clinical trial under the FDA. We look forward to announcing the
results," said Oramed CEO Nadav
Kidron.
About ORMD-0801 Oral Insulin
Oramed's ORMD-0801 is an orally ingestible insulin capsule
indicated 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, 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
(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), with trials on healthy volunteers (Phase 1b) and
T2DM patients (Phase 2a) underway. 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
visit http://www.oramed.com
Forward-looking statements: This press release
contains forward-looking statements. For example, we are using
forward-looking statements when we discuss our clinical trials 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
Office: +972-2-566-0001
Int'l: 1-718-831-2512
Mobile: +972-54-792-4438
Email: aviva@oramed.com
SOURCE Oramed Pharmaceuticals Inc.