JERUSALEM, Feb. 10, 2014 /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 that it has submitted a
protocol to the U.S. Food and Drug Administration (FDA) to initiate
a Phase 2a trial of its orally ingestible insulin capsule, ORMD
0801, for type 1 diabetes.
The protocol was submitted under Oramed's existing IND for
ORMD-0801 to include both type 1 and type 2 diabetes indications.
The double-blind, randomized, placebo controlled, seven-day study
design will be carried out at an inpatient setting on twenty-four
type 1 diabetic patients. This US- based study is expected to start
later this quarter.
"With the encouraging data from our recent Phase 2a FDA trial on
type 2 diabetic patients, we are moving forward on both the type 1
and type 2 indications by submitting this type 1 protocol to the
FDA while gearing up for the Phase 2b multi-center trial on type 2
patients to take place later this year," commented Oramed CEO
Nadav Kidron.
About ORMD-0801 Oral Insulin and T1DM
Oramed proposes to introduce ORMD-0801 to reduce the mealtime
insulin doses, introducing a treatment regimen which would allow
for fewer daily injections. Moreover, 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
(POD™) 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, 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 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 expected timing, 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 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-Guiloff
Office: +972-2-566-0001
US: 1-718-831-2512
Email: aviva@oramed.com
SOURCE Oramed Pharmaceuticals Inc.