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Oramed Pharmaceuticals Successfully Completes Phase 1A Trials
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.
Oramed Pharmaceuticals Inc.
http://www.oramedpharma.com
Oramed produse farmaceutice completeaza cu succes studii clinice de fazã 1A - Oramed Pharmaceuticals Successfully Completes Phase 1A Trials - articole medicale engleza - startsanatate