Oramed Pharmaceuticals Receives MOH and IRB Approval to Begin Phase 1 Human Trials for Oral Insulin
7/11/2006
JERUSALEM, ISRAEL, Jul 11, 2006 (CCNMatthews via COMTEX News Network) --
Oramed Pharmaceuticals Inc. (the "Company) (OTCBB:ORMP) is proud to announce the heavily anticipated application for final approval allowing the phase 1 clinical studies on healthy volunteers has been sent and successfully granted by the Israeli Ministry of Health. The Ministry of Health is responsible for supervising, monitoring, and regulating the pharmaceuticals sector, by licensing medicinal preparations and setting standards for medicinal and cosmetic preparations, as well as for toxic substances, among many other services for the public.
Preceding the MOH approval, Hadassah Medical Center IRB (Institutional Review Board) also gave their approval Oramed's application for phase 1 clinical trials of oral insulin in healthy humans. Hadassah's IRB, designed primarily to protect study participants, is made up of a group of scientists, doctors, clergy, and consumers at each health care facility that participates in a clinical trial. They will have a hand in making sure the trials are well designed, do not involve undue risk, and incorporate safeguards for patients.
With the combination of both approvals we have surpassed a large milestone now providing Oramed with clearance to begin Phase 1 clinical trials in the near future. The company hopes to achieve the same high level of success in Phase 1 that they had achieved in the previously conducted animal trials.
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 www.oramedpharma.com.
Safe Harbor Statement
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 Oramed will begin Phase 1 human trials; that we can achieve the same high level of success in Phase 1 that we achieved in the animal trials; and that the trials will be well designed, do not involve undue risk, and will incorporate safeguards for patients. 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 are not guaranteed to be approved and even if they are, there may be 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; 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 and the 8-K announcing our acquisition of the Oramed technology filed March 8, 2006.
SOURCE: Oramed Pharmaceuticals, Inc.
Oramed Pharmaceuticals, Inc. Vinisha Agnihotri Investor Relations (646) 467-2252 info@oramedpharma.com www.oramedpharma.com
Copyright (C) 2006 CCNMatthews. All rights reserved.
