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Oramed Submits New IND Application for Oral Insulin Trial in the US
Date:4/11/2013

JERUSALEM, April 11, 2013 /PRNewswire/ --

Oramed Pharmaceuticals Inc. (NASDAQCM: ORMP) (http://www.oramed.com), a developer of oral drug delivery systems, announced today that it has submitted a new Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) for a sub-study on its oral insulin candidate, ORMD-0801. This filing is in response to FDA feedback from Oramed's initial IND filing on December 31, 2012, wherein the FDA requested Oramed to perform a sub-study in a controlled in-patient setting for up to a one-week period prior to beginning the larger multi-centered Phase 2 trial.

"This new IND filing comes after ongoing productive communications with the FDA," stated Nadav Kidron , CEO of Oramed. "We look forward to receiving clearance on this IND and beginning our trials in the US."

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 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 approaching Phase 2 clinical trials under U.S. IND, and with its oral exenatide capsule (ORMD-0901; a GLP-1 analog), currently approaching Phase 2a trials. The company's corporate and R&D headquarters are based in Jerusalem.

The company's fact sheet can be viewed here.

For more information, the content of which is not part of this press release, please visit  

SOURCE Oramed Pharmaceuticals Inc.
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