REMEDY PHARMACEUTICALS INITIATES PHASE 2A STUDY OF CIRARA™ IN SPINAL CORD INJURY
NEW YORK, August 18, 2015 — Remedy Pharmaceuticals, a company focused on the development and commercialization of CIRARA™, a breakthrough drug for treating acute central nervous system conditions, today announced that a prospective multi-center 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 approximately 12,000 new cases of spinal cord injury each year in the United States. Presently, over 250,000 people in the U.S. are living with a spinal cord injury.
"There are currently no standard of care pharmaceutical strategies for the treatment of acute traumatic SCI,” notes Sven Jacobson, CEO of Remedy Pharmaceuticals. "There remains a dire need for new therapies that will give hope to these patients and their families, who otherwise face years, even a lifetime of painful recovery, and often full paralysis.”
SCI causes progressive hemorrhagic necrosis (PHN), which leads to devastating loss of spinal cord tissue. Emerging evidence point to the Sur1–Trpm4 channel as the molecular precursor of PHN. Convincing data from preclinical and human clinical studies establishes that Remedy Pharmaceuticals’ drug candidate, CIRARA, closes this channel, inhibiting spinal cord edema and micro hemorrhage formation.
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.
CIRARA is a patented, high affinity inhibitor of Sur1-Trpm4 channels suitable for intravenous delivery at the bedside or even in an ambulance. CIRARA uses our proprietary, patented MPD™ technology.
ABOUT REMEDY PHARMACEUTICALS
Remedy Pharmaceuticals, Inc. is a privately-held, clinical stage pharmaceutical company focused on bringing life saving treatment to millions of people affected by acute central nervous system conditions -- including stroke, traumatic brain injury, spinal cord injury, as well as other ischemic injuries and neurological disorders.
Contact: Sven Jacobson
212-586-2226 x 225