NEW YORK, New York, April 12, 2016 — Remedy Pharmaceuticals, a privately-held, phase 3-ready pharmaceutical company focused on bringing life saving hospital-based treatment to people affected by central nervous system (CNS) related edema, today announced that results from its Phase 2 trial of CIRARA™ for preventing edema (brain swelling) in large hemispheric infarctions will be presented during two oral presentations at the 68th annual American Academy of Neurology (AAN) meeting, the world's largest gathering of neurologists, bringing together more than 10,000 neurology professionals across the globe. This year’s weeklong meeting will take place April 15-21 in Vancouver, BC.
The two oral presentations will be conducted by principal investigators and leading neuroscience researchers at Yale University and Massachusetts General Hospital. Details for the two oral presentations include:
Session Title: Stroke Clinical Trials
Title of Talk: GAMES (Glyburide Advantage in Malignant Edema and Stroke) RP: A Phase II Study Toward Preventing Edema After Ischemia
Presenting Author: Kevin N. Sheth, MD, FAHA, FCCM, FNCS, FAAN, FANA, Associate Professor of Neurology and of Neurosurgery; Division Chief, Neurocritical Care and Emergency Neurology; Director, Neuroscience ICU W. Taylor Kimberly, MD, PhD., Associate Director, Neuroscience Intensive Care Unit; Associate Director, Neuroscience Intensive Care Unit; Massachusetts General Hospital; Assistant Professor of Neurology; Harvard Medical School, Boston, MA
Session Date: 4/16/2016
Session Time: 3:30 PM - 5:30 PM
Presentation Start: 4:45 PM
Duration: 15 minutes
Session Title: Neurocritical Care and Neuroscience Crossroads: From Bench To Bedside Title of Talk: GAMES (Glyburide Advantage in Malignant Edema and Stroke) RP Trial: Intermediate Endpoint Analysis as Proof-Of-Concept
Presenting Author: W. Taylor Kimberly, MD, PhD., Associate Director, Neuroscience Intensive Care Unit; Associate Director, Neuroscience Intensive Care Unit; Massachusetts General Hospital; Assistant Professor of Neurology; Harvard Medical School, Boston, MA
Session Date: 4/20/2016
Session Time: 1:00 PM - 5:30 PM
Presentation Start: 3:00 PM
Duration: 15 minutes
In addition to the two podium presentations, there will a poster presentation during the Neurocritical Care and Neuroscience Crossroads Session on Wednesday, April 20 at 3:00 p.m, and a poster presented along with 5-minute oral presentation in the Neurocritical Care and Neuroscience Crossroads Session on Wednesday, April 20 at 4:10 p.m.
“Edema is one of the most significant mortality risks associated with large hemispheric infarction and other acute CNS conditions,” comments Sven Jacobson, CEO of Remedy Pharmaceuticals. “For instance, in the first week following LHI, 78% of all deaths are attributable to edema and in hemorrhagic stroke, 93% of deaths are caused by this type of swelling. CNS edema continues to be a condition characterized by major unmet medical need. We look forward to beginning our phase 3 study in CIRARA, CHARM, later this year.”
ABOUT THE CHARM TRIAL AND LHI
CHARM (Cirara in large Hemispheric infarction Analyzing modified Rankin & Mortality) is a phase 3 trial in stroke patients with large hemispheric infarctions (LHI). LHI, also known as malignant middle cerebral infarction, is a devastating disease associated with significant disability and mortality. Brain swelling occurs as a result of loss of function of membrane transporters, causing sodium and water influx into the necrotic or ischemic cell, leading to cytotoxic edema. Unrelenting swelling disrupts the blood-brain barrier leading to vasogenic edema. The risk of subsequent neurological deterioration and death is high, 40% to 80%.
CIRARA is a patented, high affinity inhibitor of Sur1-Trpm4 channels, which are upregulated following ischemia and trauma. Opening of these channels can lead to damage and death of the blood brain barrier, and subsequent edema. Sur1-Trpm4 channels were discovered by University of Maryland neurosurgeon Dr. J. Marc Simard, scientific founder and board member of Remedy Pharmaceuticals. CIRARA is suitable for intravenous delivery at the bedside or even in an ambulance. CIRARA uses our proprietary, patented MPD™ technology. CIRARA is an investigational drug and is not approved by FDA.
ABOUT REMEDY PHARMACEUTICALS
Remedy Pharmaceuticals, Inc. is a privately-held, clinical stage pharmaceutical company focused on developing and bringing lifesaving treatment to millions of people affected by acute central nervous system (CNS) edema – including large hemispheric infarction and moderate/severe traumatic brain injury, as well as other ischemic injuries and neurological disorders.
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