Dimension Therapeutics announced that the Food and Drug Administration (FDA) has granted Fast Track designation to DTX101 for the treatment of hemophilia B.
DTX101 is designed to deliver Factor IX (FIX) gene expression in patients with hemophilia B, a rare genetic bleeding disorder due to deficiency in FIX. The current standard therapy involves chronic replacement of FIX protein through intravenous infusion.
Dimension expects to initiate a multi-center Phase 1/2 clinical study to evaluate DTX101 in adults with moderate-severe to severe hemophilia B by the end of 2015.
For more information visit DimensionTx.com.