Date: 2012-10-03
Type of information: Clinical research agreement
Compound: ORMD-0801 (oral insulin capsule)
Company: Oramed Pharmaceuticals (Israel) Medpace (USA)
Therapeutic area: Metabolic diseases
Type agreement: clinical research
Action mechanism:
Disease: diabetes
Details: Oramed Pharmaceuticals, a developer of oral drug delivery systems, has announced that its subsidiary, Oramed Ltd., has signed an agreement with Medpace, Inc. to retain Medpace as a Clinical Research Organization (CRO) for Oramed\'s upcoming Phase II clinical trial on its oral insulin capsule, ORMD-0801. The FDA-approved trial will assess the safety and efficacy of Oramed\'s oral insulin in 147 patients at multiple centers across the United States. Oramed plans to file an Investigative New Drug application (IND) with the FDA in this quarter and commence the trial following approval of the IND. Medpace will oversee the entire operation and data management of Oramed\'s Phase II clinical trial.
Financial terms:
Latest news:
