Oramed Partners with ETI Karle Clinical to Conduct Phase 2B Trials on Its Oral Insulin Capsule
News Sep 18, 2008
Oramed Pharmaceuticals, Inc. has 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.