JERUSALEM, Dec. 20, 2013 /PRNewswire/ -- Oramed
Pharmaceuticals Inc. (NASDAQCM: ORMP) (www.oramed.com), a
clinical-stage pharmaceutical company focused on the development of
oral drug delivery systems, announced today successful results in a
clinical trial testing the pharmacokinetic dose response of its
oral insulin capsule (ORMD-0801) in type 1 diabetes
patients.
Patients were treated with a different dose of
oral insulin at each study visit; blood glucose and insulin levels
were then monitored for the ensuing five hours. Patient
responses positively correlated with administered doses, as did the
duration of the effect.
"Based on these and the notable results from our
previous oral insulin trials in type 1 diabetes, we continue to
move forward with this indication in parallel to our advanced
clinical studies in type 2 diabetes," commented CEO Nadav Kidron.
Type 1 diabetes (T1DM) is an autoimmune disease
wherein the body destroys its own insulin-producing cells, leaving
patients completely dependent on external insulin sources. The
disease, formerly known as juvenile diabetes, currently affects
both young and adult populations. According to the International
Diabetes Federation, T1DM is on the rise at a rate of 3% per year
and currently affects approximately 36 million people worldwide -
about 10% of the global diabetes population. The disease was
formerly known as juvenile diabetes, and currently affects both
young and adult populations.
About ORMD-0801 Oral Insulin and T1DM
T1DM is currently treated with two types of insulin replacement
therapies: long-acting insulin (basal) to help maintain stable
insulin levels during fasting periods, and pre-meal insulin (bolus)
doses. Oramed proposes to introduce ORMD-0801 to replace the
mealtime (bolus) insulin doses, which would significantly reduce
the number of daily injections. Additionally, 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
(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), which has been assessed in healthy volunteers (Phase
1b) and is currently being tested in T2DM patients (Phase 2a).
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 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,
anticipated timeframe of trial results or 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 Sherman
Office: +972-2-566-0001
US: +1-718-831-2512
Email: aviva@oramed.com
SOURCE Oramed Pharmaceuticals Inc.