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March 11, 2014
08:32 EDTORMPOramed granted 3rd patient in Australia for oral administration of exenatide
Oramed announced that IP Australia, the Australian government's patent office, has issued the company its third patent in the country. The patent, titled "Methods and Compositions for Oral Administration of Exenatide," covers oral exenatide compositions made using the company's proprietary technology, including its ORMD-0901 oral exenatide capsule.Oramed has planned a comprehensive clinical program for ORMD-0901, with the goal of seeking approval in the U.S. and other territories. IND-enabling toxicity studies are scheduled to begin later this year in the U.S. and a Phase 1b study outside of the U.S. is also planned for 2014.
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October 22, 2014
08:34 EDTORMPOramed's oral insulin capsules show positive Phase IIa results
Oramed Pharmaceuticals reported positive top-line clinical results from its Phase IIa clinical trial of ORMD-0801, the company's proprietary oral insulin capsules, to treat type 1 diabetes. The trial was conducted in the U.S. under an FDA Investigational New Drug protocol. The prospective, randomized, double-blind, placebo controlled study evaluated the safety and impact of ORMD-0801 given before meals on the exogenous insulin requirements in 25 established type 1 diabetic patients. ORMD-0801 oral insulin given before meals appeared to be safe and well-tolerated. Although the study was not powered to show statistical significance, there were internally consistent trends observed. The data showed a decrease in rapid acting insulin, a decrease in post-prandial glucose, a decrease in daytime glucose by continual glucose monitoring and an increase in post-prandial hypoglycemia in the active group.

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