Date: 2015-09-10
Type of information: Clinical trial autorization
phase: 1-2
Announcement: clinical trial authorization
Company: Dimension Therapeutics (USA - MA)
Product: DTX101
Action
mechanism: gene therapy. DTX101 is designed to deliver blood clotting Factor IX (FIX) gene expression in patients with hemophilia B. DTX101, is expected to enter clinical development in 2015, for the treatment of moderate/severe to severe hemophilia B.
Disease: hemophilia B
Therapeutic area: Rare diseases - Genetic diseases - Hematological diseases
Country:
Trial details:
Latest
news: * On September 10, 2015, Dimension Therapeutics, a leading gene therapy platform company focused on discovering and developing new therapeutic products for people living with rare diseases associated with the liver, announced that the FDA accepted Dimension’s investigational new drug (IND) application and granted orphan drug designation for the Company’s lead product candidate, DTX101, for the treatment of hemophilia B. Dimension expects to initiate a multi-center phase 1/2 study in adults to evaluate DTX101 in adult patients with moderate/severe to severe hemophilia B by the end of 2015.
