JERUSALEM, September 9, 2015 /PRNewswire/ --
Oramed Pharmaceuticals Inc. (NASDAQ: ORMP)
(http://www.oramed.com), a clinical-stage pharmaceutical company
focused on the development of oral drug delivery systems, announced
today that 98 patients have already been enrolled in the Company's
Phase IIb study of its oral insulin capsule, ORMD-0801, which
represents more than 50% of the 180 patients expected to be
recruited for the trial. The double-blind, randomized Phase IIb
study for type 2 diabetes was initiated on June 30th and is designed to generate
ample data for both efficacy and safety endpoints.
"We are extremely pleased with the pace of patient enrollment in
the trial, which is in line with our expectations. The principal
investigators and clinics participating in the trial include some
of the most prestigious in the United
States," stated Oramed CEO Nadav
Kidron.
About ORMD-0801 Capsule for Type 2 Diabetes
ORMD-0801 has the potential to create a new paradigm in the
treatment of diabetes by oral delivery of insulin at an earlier
stage of treatment, potentially slowing disease progression and
delaying or even eliminating late-stage complications. Orally
administered insulin should bring with it enhanced patient
compliance. In addition, intestinally absorbed-oral insulin
actually mimics insulin's natural location and gradients in the
body by first passing through the liver before entering the
bloodstream.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a technology pioneer in the field of
oral delivery solutions for drugs currently delivered via
injection. Established in 2006, Oramed's Protein Oral Delivery
(POD[TM]) technology is based on
over 30 years of research by top 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). Having completed multiple Phase IIa clinical
trials, the company has started its Phase IIb on type 2 diabetes
under an Investigational New Drug application with the U.S. Food
and Drug Administration. In addition the company is developing an
oral GLP-1 analog capsule (ORMD-0901).
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 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 expected patient enrollment, 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 finally 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
Ariella Vaystooch
Office: +972-2-566-0001 ext. 2
US: +1-718-831-2512 ext. 2
Email: ariella@oramed.com
SOURCE Oramed Pharmaceuticals Inc.