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February 10, 2014
09:54 EDTORMPOramed submits Phase 2a protocol to FDA for treatment of Type 1 diabetes
Oramed Pharmaceuticals announced that it has submitted a protocol to the U.S. Food and Drug Administration to initiate a Phase 2a trial of its orally ingestible insulin capsule, ORMD 0801, for type 1 diabetes. The protocol was submitted under Oramed's existing IND for ORMD-0801 to include both type 1 and type 2 diabetes indications. The double-blind, randomized, placebo controlled, seven-day study design will be carried out at an inpatient setting on twenty-four type 1 diabetic patients. This US- based study is expected to start later this quarter.
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April 24, 2014
14:33 EDTORMPOramed says ORMD-0801 appeared safe and well-tolerated in phase IIa trial
Oramed Pharmaceuticals announced detailed results from its previously completed Phase IIa trial investigating ORMD-0801, its orally ingestible insulin capsule, in type 2 diabetes patients. The preliminary results of this trial were originally announced on January 30. The results showed that ORMD-0801 oral insulin appeared to be safe and well-tolerated for the dosing regimen considered in this study. No hypoglycemic events occurred at any point in any treatment group and no treatment related adverse events were observed. Although the study was not powered to show statistical significance, there were trends observed showing pattern of well-defined and short-term increases in plasma insulin and decreases in blood glucose. Chief Scientific Officer Dr. Miriam Kidron stated, "We are very pleased with the outcome of this study, which showed ORMD-0801 to be safe and well-tolerated. Importantly, the decreases in blood glucose we observed were not associated with any hypoglycemic events. We look forward to moving ahead with our planned U.S. Phase IIb trial in individuals with type 2 diabetes which will investigate ORMD-0801 over a longer treatment period and which will have statistical power to give us greater insight into the drug's efficacy."
April 10, 2014
08:11 EDTORMPOramed granted patent in Hong Kong for oral administration of insulin
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