Posted by Michael Wonder on 02 Jul 2018
Fortress Biotech announces Cyprium Therapeutics’ CUTX-101 (copper histidinate) granted FDA fast track designation for treatment of classic Menkes disease
2 July 2018 - Fortress Biotech today announced that the U.S. FDA has granted fast track designation to Cyprium Therapeutics’ (“Cyprium”) copper histidinate, also referred to as CUTX-101, for patients diagnosed with classic Menkes disease who have not demonstrated significant clinical progression.
As a subsidiary of Fortress, Cyprium is developing CUTX-101 for Menkes disease under a Cooperative Research and Development Agreement (CRADA) with the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), part of the National Institutes of Health (NIH). The CRADA was established in March 2017. Stephen G. Kaler, M.D., Senior Investigator and Head, Section on Translational Neuroscience and former NICHD Clinical Director, leads the Menkes disease research program at NICHD and serves as principal investigator of the CUTX-101 Phase 3 clinical trial.
