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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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