Oramed Pharmaceuticals Successfully Completes Phase 1A Trials
August 14 2007 - 7:47AM
PR Newswire (US)
JERUSALEM, Israel, August 14 /PRNewswire-FirstCall/ -- Oramed
Pharmaceuticals, Inc. (OTCBB: ORMP), a developer of peptide
delivery systems, is pleased to announce that it has successfully
completed its exploratory Phase 1A clinical trial with it's oral
insulin gel capsule. This study was intended to assess both the
safety/tolerability and absorption properties of Oramed's
proprietary oral insulin delivery technology. The trial examined
changes in insulin, glucose and C-peptide plasma concentrations
over time in healthy volunteers under several differing oral dosing
scenarios. With the exception of the anticipated insulin related
hypoglycemic side effects, no significant adverse effects were
noted after administration of Oramed's insulin gel capsule. Nadav
Kidron, CEO of Oramed, stated, "We have crossed a significant
milestone with the completion of our human feasibility Phase 1A
trials with our first product. Although preliminary in nature, the
study was actually well designed being a single blind, open-label,
study to assess the safety, pharmacokinetics and pharmacodynamics
of Oramed's oral insulin. The results from this exploratory study
confirm on a preliminary basis the applicability and safety of
Oramed's peptide delivery technology in humans. We are all very
encouraged by these findings." Based on the pharmacokinetic and
pharmacologic outcomes of this early stage trial, the company and
Board of Directors has decided to continue the development of our
oral insulin product. Additional Phase I
bioavailability/pharmacokinetic trials to optimize/finalize the
formulation are anticipated to begin later this year. The company's
goal is for the completion of formal Phase 1 studies in the US by
mid-2008. " About Oramed Pharmaceuticals Oramed Pharmaceuticals' is
an Israeli based company focused on the development of oral
delivery solutions based on proprietary technology. Diabetes is one
of the most rapidly growing diseases in the world and is one that
requires constant and often unpleasant monitoring and drug therapy
regimen. Oramed is currently developing an orally ingestible soft
gel insulin capsule for the treatment of diabetes. The Company is
also pursuing the development of oral delivery solutions for other
drugs and vaccines. For more information please visit our website
at: http://www.oramedpharma.com/ Legal Notice and Forward Looking
Statements For Oramed Pharmaceuticals This news release contains
statements, which may constitute "forward-looking statements".
Those statements include statements regarding the intent, belief or
current expectations of Oramed Pharmaceutical Inc., and members of
our management as well as the assumptions on which such statements
are based. Forward-looking statements in this release include: that
we are currently developing an orally ingestible soft gel insulin
capsule for the treatment of type 1 and 2 diabetes; that we are
pursuing the development of oral delivery solutions for other drugs
and vaccines; that additional Phase I
bioavailability/pharmacokinetic trials to optimize/finalize the
formulation are anticipated to begin later this year; that the
company's goal is for the completion of formal Phase 1 studies in
the US by mid-2008.. Factors which may significantly change or
prevent our forward looking statements from fruition include that
we may be unsuccessful in developing any products; that human
trials may suffer unforeseen difficulties or adverse medical
effects on participants; that our technology may not be validated
as we progress further and our methods may not be accepted by the
scientific community; that we are unable to retain or attract key
employees whose knowledge is essential to the development of our
products; that unforeseen scientific difficulties develop with our
process; that our patents are not sufficient to protect essential
aspects of our technology; that competitors may invent better
technology to treat or cure diabetes or that the market for
diabetes drugs does not increase; that studies are cut short by
unexpected problems with our methodology; that our products may not
work as well as hoped or worse, that our products may harm
recipients; and that we may not be able raise funds for development
or working capital when we require it. As well, our products may
never develop into useful products and even if they do, they may
not be approved for sale to the public. For further risk factors
see the Company's latest 10-KSB filed with the SEC . For further
information, please contact: Oramed Pharmaceuticals, Inc Investor
Relations: Vinisha Agnihotri +1-646-467-2252 (Office)
http://www.oramedpharma.com/ DATASOURCE: Oramed Pharmaceuticals
Inc. CONTACT: For further information, please contact: Oramed
Pharmaceuticals, Inc, Investor Relations: Vinisha Agnihotri,
+1-646-467-2252 (Office),
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