Oral drug delivery system developer Oramed Pharmaceuticals Inc. (OTC BB:ORMP.OB) announced today that it had signed a deal with an Indian firm to conduct Oramed's Phase II clinical trial.
The agreement was signed with ETI Karle Clinical Pvt. Ltd., a clinical research organization (CRO) located in India, to conduct Phase IIB clinical trials on Oramed's oral insulin capsules.
The study is intended to evaluate the safety, tolerability and efficacy of ORMD 0801, Oramed’s oral insulin capsule, on diabetic type 2 patients.
It is anticipated that the Phase IIB study will be conducted over several months starting in the first quarter of 2009, with approximately 60 subjects participating in the trial.
Oramed CEO Nadav Kidron said, “This trial is intended to affirm that ORMD 0801 will perform to our expectation on a large group of type 2 diabetes patients.”
ETI Karle Clinical Pvt. Ltd is a clinical research organization headquartered in Bangalore with a network of 60 clinical trial sites.
Jerusalem-based Oramed is based on research by scientists at Jerusalem’s Hadassah Medical Center.
Published by Globes [online], Israel business news - www.globes-online.com - on September 9, 2008
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