JERUSALEM, April 28, 2015 /PRNewswire/ --
Oramed Pharmaceuticals Inc. (NASDAQ: ORMP)
(http://www.oramed.com)
Dear Friends, Shareholders and Associates,
I am very excited to announce that we are on the threshold of
initiating our much-awaited Phase IIb clinical trial for oral
insulin (ORMD-0801) and the treatment of type 2 diabetes. Our
goal is to commence the trial in the coming weeks. This
clinical trial will be our largest and most comprehensive study to
date and marks a significant milestone for the company, literally
putting us in a different place.
The Phase IIb study will build directly on the success of our
two Phase IIa studies which were completed in 2014. This study will
be significantly larger in scope and design than the prior studies
so as to demonstrate both efficacy and safety as primary
endpoints.
I am happy to share, that the study has already received
Institutional Review Board (IRB) approval and we plan on submitting
the study's protocol to the Federal Drug Administration (FDA) in
the coming month of May, which will be followed soon thereafter by
study enrolment. We are positioned for an efficient recruitment
process, having successfully recruited over 30 clinical sites,
which include some of the most prestigious clinics and
investigators in the United
States.
We look forward to embarking on this important next step and, as
usual, we will keep you abreast as this study progresses.
Sincerely,
Nadav Kidron, CEO
Forward-looking statements: This letter 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 Phase IIb clinical
trial for oral insulin and its significance to us, including the
scope, design and expected timing thereof, or when we discuss the
timing of submitting the study's protocol to the FDA, 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
Ariella Vaystooch
Office: +972-2-566-0001 ext. 2
US: +1-718-831-2512 ext. 2
Email: ariella@oramed.com
SOURCE Oramed Pharmaceuticals Inc.