JERUSALEM, April 1, 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 the first patient has been enrolled in its Glucose Clamp
Study. The study will be performed at The University of Texas Health Science Center at
San Antonio and University Health
System's Texas Diabetes Institute under the supervision of
Professor Ralph DeFronzo.
The glucose clamp is a method for quantifying insulin absorption
in order to measure a patient's insulin sensitivity and how well a
patient metabolizes glucose. The glucose clamp technique represents
the gold standard for pharmacodynamic studies in diabetes drug
development.
In addition to the clamp study, Oramed plans to initiate its
Phase IIb oral insulin trial in the U.S. with a protocol which
includes over 30 U.S. sites covering approximately 180 patients and
has both efficacy and safety as its primary end-points.
"We are pleased to have initiated this study and enrolled the
first patient. We are additionally excited at the prospects of
starting our larger Phase IIb trial in the near term. The
data from the two trials will allow for a clearer picture of our
oral insulin and its pharmacological characteristics as we move
forward with our development plan," stated Oramed CEO Nadav Kidron.
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 separate Phase IIa clinical trials,
the company anticipates the initiation of separate Phase IIb
clinical trials, in patients with both type 1 and 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 the proposed timing and design of such studies, 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.