Drug Trial Results For Remedy Pharmaceuticals, Inc.’ CIRARA Could Change Stroke Treatment Forever, Saving And Improving Millions Of Lives

NEW YORK--(BUSINESS WIRE)--Remedy Pharmaceuticals, Inc. today announced that the GAMES-RP study of the drug CIRARA™ (RP-1127) in severe stroke has successfully ended enrollment with 83 patients. Results from the study are expected in September 2015.

“The results of this trial could change how millions of stroke patients are treated. We will know soon enough.”

Eighteen leading medical centers were involved in the GAMES-RP trial (in alphabetical order): Abington Memorial Hospital, Abington, PA; Cleveland Clinic, Cleveland, OH; Maine Medical Center, Portland, ME; Massachusetts General Hospital, Boston, MA; Medical University of South Carolina, Charleston, SC; Northwestern Memorial Hospital, Chicago, IL; Oregon Health & Science University Hospital, Portland, OR; Ohio State University/Wexner Medical Center, Columbus, OH; Rutgers (Robert Wood Johnson University Hospital), New Brunswick, NJ; Stanford University Medical Center, Stanford, CA; UMASS Memorial Medical Center, Worcester, MA; University of Arizona Medical Center - University Campus, Tucson, AZ; University of Florida, Jacksonville, FL; University of Louisville Hospital, Louisville, KY; University of Maryland Medical Center, Baltimore, MD; University of Utah Healthcare, Salt Lake City, UT; UPMC Presbyterian Hospital, Pittsburgh, PA; and Yale-New Haven Hospital, New Haven, CT.

Stroke is the second leading cause of death globally, with approximately 16 million victims each year¹, or one every other second of every day. About a third of all strokes result in death. Another third of victims will be permanently disabled, some even left in a vegetative state. The lifetime risk of stroke in men is 1 in 6; it’s 1 in 5 for women².

Approximately 800,000 Americans suffer a stroke each year. The non-nursing home direct costs amount to over 10% of the total U.S. Medicare budget and 1.7% of overall national health costs³.

Some 85% of all strokes are ischemic strokes, caused by a clot obstructing the flow of blood to the brain. There is currently only one FDA approved drug for ischemic strokes, tPA⁴. Protocol guidelines require its use within the first three hours of the event (and up to 4.5 hours in certain eligible patients), after which its detriments may outweigh its benefits. As a result, tPA is used in less than 5 percent of all stroke cases.

GAMES-RP is a randomized, double blind, placebo controlled, multi-center, Phase 2 study of CIRARA in patients with a severe ischemic stroke. GAMES-RP follows a highly-successful pilot trial completed in 2012 involving patients with severe stroke who would normally experience major swelling in over 80 percent of cases. In stark contrast, the proportion of patients in the pilot study who survived without such severe disability was 90%, a reversal of the dire natural history of severe stroke. Follow up MRI images were notable for qualitative findings including absence of mass effect, and preservation of white matter.

Dr. Kevin Sheth, MD, chief, Division of Neurocritical care and Emergency Neurology, and chief of clinical research, Department of Neurology, Yale University, New Haven, Connecticut, and the Principal Investigator of the study, and co-Principal Investigator of the GAMES-RP study, received the coveted Robert G. Siekert New Investigator Award in Stroke for his work on the pilot study. “We’re biased, but we believe that this is probably the most exciting treatment in acute stroke since the advent of tPA (tissue plasminogen activator),” said Dr. Sheth following the pilot study, continuing: “We were excited because right now we have nothing to offer these patients and they often have a poor outcome, and also because the biology is very interesting and very different from what the stroke field has been doing for the last 2 decades.”

“There is a pressing need for new drugs to treat central nervous system disorders,” notes Sven Jacobson, CEO of Remedy Pharmaceuticals. “The results of this trial could change how millions of stroke patients are treated. We will know soon enough.”

ABOUT CIRARA

CIRARA is a patented intravenous formulation that can be delivered bedside or even in an ambulance. CIRARA uses our proprietary, patented MPD™ dosing 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 central nervous system conditions -- including stroke, traumatic brain injury, spinal cord injury, as well as other ischemic injuries and neurological disorders.