New User:

Forgot your password?

Stock Market & Financial Investment News

News Breaks
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.
News For ORMP From The Last 14 Days
Sign up for a free trial to see the rest of the stories you've been missing.
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.

Sign up for a free trial to see the rest of the stories you've been missing.

I agree to the disclaimer & terms of use