Drug delivery systems developer Oramed Pharmaceuticals Inc. (Bulletin Board:ORMP); DAX:OJU) last week reported positive results from its recently completed Phase IIb clinical trial of its oral insulin capsule, ORMD-0801.
The six-week trial, conducted in South Africa, was not for the US Food and Drug Administration (FDA). It included 29 patients with type 2 diabetes. The capsule was found to be safe and well tolerated, and there were no adverse side effects. Patients given the drug showed clinically relevant reductions in insulin c-peptide, fasting blood glucose and Hb1Ac levels were always higher compared with patients given the placebo. Average insulin levels were statistically significantly lower.
Oramed said that it will use the trial results for further development of ORMD-0801, and in future, pivotal trials.
Oramed CEO Nadav Kidron said, "This study, as well as data from our earlier studies, suggests that Oramed's technology is an effective and well-tolerated delivery platform that will potentially make a significant clinical impact on diabetes management. We are proceeding with confidence toward IND approval in the US."
Oramed's share closed at $0.50 in New York on Friday.
Published by Globes [online], Israel business news - www.globes-online.com - on May 10, 2010
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