Oramed Phase 2 for Oral Insulin

Oramed Pharmaceuticals Inc. (OTCBB:ORMP.OB) has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a Phase 2 clinical trial of its orally ingested insulin candidate, ORMD-0801. The trial is to include 147 type 2 diabetic patients in multiple centers across the United States. If Oramed does not receive comments from the FDA on the IND application within 30 days from filing, Oramed intends to immediately commence the trial to evaluate the safety, tolerability and efficacy of its oral insulin capsule on type 2 diabetic volunteers.

According to the 2011 National Diabetes Fact Sheet as reported by the Centers for Disease Control and Prevention (CDC) nearly 8.3% of Americans had diabetes in 2010 – approximately 25.8 million people. The same report noted that the 2007 expense for diabetes treatment in the Unites states was $174 billion, with direct costs for treatment representing $116 billion – a number that is 2.3 times higher than the medical costs of someone who does not have diabetes.