Stroke Trial Hopes To Save Lives And Extend The Treatment Window
Phase 2 study of RP-1127 enrolls first patient with severe ischemic stroke
New York, NY, USA – July 9, 2013 – Remedy Pharmaceuticals, Inc. today announced that the GAMES-RP study of RP-1127 in severe stroke enrolled and treated its first patient. This study follows a highly-successful pilot trial completed last year involving patients with severe stroke who would normally experience major swelling in over 80 percent of cases. The trial turned those dire statistics on their head, with only a 20 percent incidence rate. This extraordinary finding, along with striking imaging and biomarker outcomes, lead Remedy to undertake the GAMES-RP study.
Every 40 seconds of every day someone in the United States has a stroke. Stroke is the third leading cause of death in America, surpassed only by heart disease and cancer, and is the primary cause of serious long-term disability in adults. There are 795,000 strokes in the U.S. each year, resulting in nearly 150,000 deaths. Annual costs to the healthcare system are estimated at $56.8 billion.
GAMES-RP is a randomized, double blind, placebo controlled, multi-center, Phase 2 study of RP-1127 in patients with a severe ischemic stroke who are likely to experience clinically significant brain swelling, culminating in further ischemic damage, enlargement of the infarct, brain herniation, and death.
The study is currently enrolling at Massachusetts General Hospital, Yale New Haven Hospital, Northwestern Memorial Hospital, Ohio State University Wexner Medical Center, and Oregon Health & Science University Hospital. Additional sites around the country will be activated during July and August.
“Three recent randomized studies of thrombectomy devices for acute stroke have shown we have likely reached the limits of reperfusion therapy,” says Sven Jacobson, Chief Executive Officer of Remedy. “There are currently no proven treatment options for stroke other than rtPA, which must be administered within 4.5 hours of stroke, and none for preventing brain swelling, which is devastating in these severe strokes. This study is a significant milestone for Remedy as well as for stroke patients everywhere.”
Detailed information for this study is available at: http://clinicaltrials.gov/ct2/show/ NCT01794182
Remedy’s lead drug candidate, RP-1127, is a high affinity, well tolerated inhibitor of NCCa-ATP swelling (edema) and hemorrhage following ischemic and traumatic injury.
About Remedy Pharmaceuticals
Remedy Pharmaceuticals, Inc. is a clinical stage pharmaceutical company focused on the development and commercialization of small molecule drugs for acute central nervous system disorders including stroke, traumatic brain injury, and spinal cord injury.