Novoteris LLC's Phase 2 clinical trial application for inhaled nitric oxide as a treatment for cystic fibrosis has been approved by both the U.S. Food and Drug Administration and the Therapeutic Products Directorate of Health Canada.
Novoteris is now recruiting subjects for the Phase 2 trial in cystic fibrosis research facilities in Seattle; Los Angeles; Milwaukee; Charleston, South Carolina; and Vancouver, British Columbia. Sixty subjects will be given, on a randomized basis, either Thiolanox nitric oxide or a placebo treatment. The treatment will be delivered by a unique computerized trace-gas mixing system.
“The clearances by the FDA and Health Canada will enable us to advance our work with this novel therapy and represents an important step for Novoteris” Novoteris President Alex Stenzler said in a statement.
Cystic fibrosis, an autosomal recessive genetic disorder, most critically affects the lungs and, in turn, a patient’s ability to breathe.