Human Study Shows Remedy Pharmaceuticals’ CIRARA™ Is Key To Preventing Brain Swelling In Stroke7/28/2015
PRESS RELEASE
HUMAN STUDY SHOWS REMEDY PHARMACEUTICALS’ CIRARA™ IS KEY TO PREVENTING BRAIN SWELLING IN STROKE. In the first week of an ischemic stroke, 78% of deaths are attributable to swelling. Is CIRARA the miracle treatment for victims of stroke? Results of a clinical trial in severe stroke patients expected in September will answer that question. NEW YORK, July 28, 2015 — Remedy Pharmaceuticals, a company focused on the development and commercialization of CIRARA™, a breakthrough drug for treating acute central nervous system conditions such as stroke, today announced publication of a peer-reviewed paper1 that confirms administering CIRARA for pharmacologic targeting of the Sur1-Trpm4 channel in human ischemic stroke to reduce blood-brain barrier disruption and cerebral edema is a promising therapeutic strategy. 16 MILLION STROKE VICTIMS EACH YEAR; SWELLING IS THE LEADING CAUSE OF DEATH Stroke is the second leading cause of death globally, with approximately 16 million victims each year2. About a third of all strokes result in death, and another third in permanent disability. Stroke occurs when the supply of blood to the brain is either interrupted or reduced. When this happens, brain cells start to die almost immediately. Edema, or swelling, is the body's response to many types of injury, including injury to the brain, as in a stroke. In fact, edema is one of the biggest mortality risks associated with stroke. In the first week of an ischemic stroke, caused by a blockage in the blood vessels supplying blood to the brain, 78% of all deaths are attributable to edema. In hemorrhagic stroke, or bleeding in the brain, 93% of deaths in the first week are caused by swelling.3 STUDY LINKS UPREGULATION OF CHANNEL TO SWELLING IN STROKE PATIENTS Investigators at University of Maryland analyzed ischemic lesions in brain specimens from 13 ischemic stroke victims who died and underwent autopsy. For comparison, contralateral cortex samples were evaluated as control tissue. Brain specimens from 6 patients with documented absence of ischemic stroke also were examined as controls. Investigators found that the Sur1-Trpm4 cation channel, which is not constitutively present in (CNS) nervous system tissues, was transcriptionally upregulated in infarcted brain cortexes, but not in non-infarcted cortexes. Sur1-Trpm4 channels have previously been shown to be upregulated de novo under neuropathologic conditions, such as in a stroke. These channels otherwise lie dormant in the endothelial cell membrane, doing no harm unless they are opened by depletion of intracellular energy. Channel opening leads to sustained influx of sodium, which, if unchecked, leads to formation of life threatening space-occupying edema. Prior molecular evidence of their expression in ischemic stroke was based on animal models, and this is the first time these channels have been proven to be upregulated in human ischemic stroke. A ROLE FOR CIRARA IN CLOSING THIS CHANNEL This study and other findings suggest an important role for the Sur1-Trpm4 channel in the pathophysiology of stroke and implicate pharmacologic blockade of the channel as a possible novel therapeutic strategy for mitigating malignant cerebral edema in patients sustaining large territorial cerebral infarction. Convincing evidence from preclinical and human clinical studies establish that Remedy Pharmaceuticals’ drug candidate, CIRARA, closes this channel, inhibiting cerebral edema, which is a significant contributor to mortality and poor patient outcomes. CIRARA TRIAL RESULTS COULD BE A GAME CHANGER FOR STROKE VICTIMS On May 5, Remedy announced it had successfully ended enrollment in GAMES-RP, a Phase 2, randomized double blind, placebo-controlled, multi-center trial of CIRARA in severe stroke patients. Results from the study are expected in September of this year. GAMES-RP follows a highly-successful pilot trial completed in 2012 involving patients with severe stroke who in over 80% of cases, would be expected to experience major brain swelling. In stark contrast, 90% of patients in the pilot study survived without severe disability, 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. 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 1. [Mehta RI et al. Sur1-Trpm4 Cation Channel Expression in Human Cerebral Infarcts. J Neuropathol Exp Neurol. 2015 Aug;74(8):835-49. ] 2. [Krishnamurthi RV et al. Global and regional burden of first ever ischaemic and haemorrhagic stroke during 1990-2010. Lancet Global Health. 2013:1:e259-81 ] 3. [Silver FL et al. Early mortality following stroke: a prospective review. Stroke. 1984 May-Jun;15(3):492-6 ]
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PRESS RELEASE
REMEDY PHARMACEUTICALS EXPANDS ITS BOARD IN ANTICIPATION OF STROKE TRIAL RESULTS Kurt Landgraf, former head of DuPont Merck Pharmaceuticals, joins as a board member; Charles Mele, former EVP and General Counsel for HLTH Corp., parent of WebMD, and Mark McEwen, former CBS newscaster and stroke survivor, to act as board advisors. NEW YORK, July 7, 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 the appointment of a new board member and two board advisors. Joining as an independent board director is Kurt Landgraf, former head of DuPont Pharmaceuticals, part of DuPont (NYSE: DD) and past President and CEO of DuPont Merck Pharmaceuticals, which was acquired by Merck (NYSE: MRK) in 1998. Landgraf also held the positions at DuPont of Chief Financial Officer, Executive Vice President, Chief Operating Officer and Chairman of DuPont Europe. Landgraf is a member of the Board of Directors at the Corning (NYSE: GLW) and Louisiana Pacific corporations (NYSE: LPX). “Remedy has developed a novel therapy that has the potential to save and improve lives,” notes Landgraf. “It’s truly exciting to be part of an organization that’s addressing a large unmet medical need.” Remedy also announced two key board advisory appointments: Acting as special advisor to the Remedy board is Charles Mele, who currently serves as Special Counsel to WebMD Health Corp (NASDAQ: WBMD). Previously he served as Executive Vice President and General Counsel of HLTH Corporation and the then corporate parent of WebMD. Mr. Mele has been associated in senior executive positions with several high growth health care companies in his 30-year career including Medco Containment Service, Medical Manager and Emdeon Corporation. “I am eager to offer the experience I have gained by being deeply involved in some of the fastest growing and innovative, publicly traded healthcare businesses,” remarks Charles Mele, adding, “and look forward to working closely with David and Sven and the board as Remedy continues to grow and evolve.” Mark McEwen also joins Remedy as a special advisor. For over 15 years, McEwen was a mainstay at CBS News (NYSE:CBS), serving in a variety of high profile positions, including anchor of CBS This Morning for three years. In 2005 McEwen suffered a massive stroke. His remarkable recovery is chronicled in his book, "After The Stroke: My Journey Back to Life. Mark will be the Stroke Education Ambassador for Remedy. “I know first hand what it’s like to suffer a stroke,” states McEwen, “Stroke is not about a dry set of statistics; it’s about people, and families, and courage and dignity, and never giving up. Remedy understands that – which is why I’m so happy to be a part of their team.” “Kurt’s over 45 years of commercial experience including 30 years in the pharmaceutical industry will be extremely valuable as Remedy draws closer to commercialization,” says David Geliebter, Remedy’s Executive Chairman. "Charles Mele’s unparalleled track record on legal and commercial matters will be extremely valuable as we shape this next phase of the company’s future. We’re thrilled to be able to work with him and with Mark McEwen, whose unique personal experience with stroke is a constant reminder of how important what we do is to the people most in need.” On May 5, Remedy announced it had successfully ended enrollment in GAMES-RP, a Phase 2, double blind, placebo-controlled, multi-center trial of CIRARA in severe stroke patients. Results from the study are expected in September of this year. GAMES-RP follows a highly-successful pilot trial completed in 2012 involving patients with severe stroke who would be expected, in over 80% of cases, to experience major brain swelling. In stark contrast, 90% of patients in the pilot study survived without severe disability, 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. ABOUT CIRARA 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 sven@remedypharmaceuticals.com |