Oramed Pharmaceuticals, Inc. (OTCBB: ORMP.OB), a developer of oral delivery systems, announced the signing of an agreement with ETI Karle Clinical Pvt. Ltd., a clinical research organization (CRO) located in India, to conduct Phase 2B clinical trials on its 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 2B study will be conducted over several months starting in the first quarter of 2009, with approximately 60 subjects participating in the trial.
"Oramed has been able to demonstrate that ORMD 0801 has a good safety profile and effective on a small group of diabetes patients. This trial is intended to affirm that ORMD 0801 will perform to our expectation on a large group of type 2 diabetes patients," said Nadav Kidron, CEO of Oramed.
ETI Karle Clinical Pvt. Ltd is a Pan-Asian CRO, headquartered in Bangalore with a network of 60 clinical trial sites across all therapeutic areas, with access to 2 million patients, and 120 researchers.
About Oramed Pharmaceuticals
Oramed Pharmaceuticals is a technology pioneer in the field of oral delivery solutions for drugs and vaccines presently delivered via injection. Oramed is seeking to revolutionize the treatment of diabetes through its patented flagship product, an orally ingestible insulin capsule currently in phase 2 clinical trials. Established in 2006, Oramed's technology is based on over 25 years of research by top research scientists at Jerusalem's Hadassah Medical Center. The Company's corporate and R&D headquarters are based in Jerusalem.
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Oramed Pharmaceuticals, Inc.