Date: 2013-04-29
Type of information:
phase: 1
Announcement: IND approval
Company: Erydel (Italy)
Product: EryDex® (dexamethasone sodium phosphate delivered through autologous erythrocytes)
Action mechanism:
Disease: ataxia telangiectasia
Therapeutic area: Rare diseases
Country: USA
Trial details:
Latest
news: * On April 29, 2013, EryDel, a drug delivery company specialized in the development of drugs and diagnostics delivered through red blood cells (RBCs), has announced that it has received approval to start its first study in the US. The Investigational New Drug (IND) Application for EryDex® (dexamethasone sodium phosphate delivered through autologous erythrocytes) was filed on March 24, 2013. The IND was filed after a pre-IND meeting with FDA representatives from the Division of Neurological Products and the Center for Biologics, who provided valuable input concerning requirements for the program. FDA previously granted EryDex Orphan Status for the treatment of AT. EryDel reported earlier that treatment with EryDex met the primary endpoint of improvement in neurological symptoms in a 6-month prospective study in patients with AT.
