Remedy initiates phase IIa study of CIRARA
Wednesday, August 19, 2015
Remedy Pharmaceuticals, a company focused on the development and commercialization of CIRARA, a breakthrough drug for treating acute central nervous system conditions, has initiated a prospective, multicenter, open-label pilot study of CIRARA in patients with acute traumatic cervical spinal cord injuries.
Up to five Level I trauma centers will be involved in the trial, including University of Ohio Wexner Medical Center as Principal Site. The study’s principal investigator is H. Francis Farhadi, M.D., Ph.D., clinical assistant professor, Department of Neurological Surgery and director, Spinal Surgery Fellowship Program at The Ohio State University.
According to the World Health Organization, annually there are somewhere between 133,000 and 226,000 cases of spinal cord injury worldwide. There are about 12,000 new cases of spinal cord injury each year in the United States. Presently, more than 250,000 Americans are living with a spinal cord injury.
The study will enroll and treat up to a maximum of 10 patients who will be matched in a 1:3 ratio with historical controls. Patients with cervical (C4-C8) level complete or incomplete injuries who are aged 18 to 70 years old will be eligible for inclusion in the study.
The data obtained from this pilot study should inform the design of further multicenter phase II/III clinical studies evaluating the efficacy of CIRARA in improving functional outcomes following SCI.