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Remedy Pharmaceuticals Announces Two Oral Presentations on Results of CNS-Related Edema Trial At Annual American Academy of Neurology Meeting
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%. ABOUT CIRARA 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. Contact: Remedy Pharmaceuticals Sven Jacobson 212-586-2226 x 225 sven@remedypharmaceuticals.com
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PRESS RELEASE
Remedy Pharmaceuticals Issues First Quarter 2016 Report NEW YORK, New York, April 6, 2016 — Remedy Pharmaceuticals, a privately-held pharmaceutical company focused on bringing life-saving hospital-based treatment to people affected by central nervous system related edema, today announced that the Company issued an end-of-first-quarter report. Highlights of the report include six-month data from its Phase 2 randomized, double blind trial of the drug CIRARA™ in large hemispheric infarctions, adjudicated neurological mortality findings, and results of an analysis on patients 70 and younger. The report may be downloaded at http://www.remedypharmaceuticals.com/investor-information.html Cerebral edema (swelling) can result from brain trauma or from non-traumatic causes.. The brain is especially susceptible to injury from edema because it is located within a confined space and cannot expand. If not treated, cerebral edema may cause permanent disability or death. In the Company’s phase 2 study, GAMES-RP, edema caused almost 60% of deaths in the placebo arm. 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, traumatic brain injury, spinal cord injury, as well as other ischemic injuries and neurological disorders. Contact: Remedy Pharmaceuticals Sven Jacobson 212-586-2226 x 225 sven@remedypharmaceuticals.com Remedy Pharmaceuticals Appoints Dr. Thomas R. Zimmerman Jr. as Vice President, Medical Affairs4/5/2016 PRESS RELEASE
Remedy Pharmaceuticals Appoints Dr. Thomas R. Zimmerman Jr. as Vice President, Medical Affairs NEW YORK, New York, April 5, 2016 — Remedy Pharmaceuticals, a privately-held pharmaceutical company focused on bringing life-saving hospital-based treatment to people affected by central nervous system (CNS) related edema, today announced the appointment of Dr. Thomas R. Zimmerman Jr. as its Vice President, Medical Affairs. “Dr. Zimmerman’s deep passion for leveraging breakthroughs in science to save and improve patients’ lives – which is completely in line with Remedy’s stated mission and core values – makes him an ideal addition to the senior management team,” states Sven Jacobson, CEO of Remedy Pharmaceuticals. “His extensive experience in clinical drug development and deep knowledge of the regulatory environment are certain to prove invaluable as we prepare to enter a Phase 3 clinical trial for CIRARA, and beyond.” Thomas R. Zimmerman Jr., MD, F.A.A.N, has over 30 years of medical experience as well as 25 years in clinical drug development, having been an integral part of five New Drug Applications and four commercial drug launches. He has lead 18 acute neurology studies, and has consulted with over 30 companies including Wyeth, now part of Pfizer (NYSE:PFE), Johnson & Johnson (NYSE:JNJ), Biogen (NASDQ:BIIB), and Teva (NYSE:TEVA). Prior to his consulting work, Dr. Zimmerman was the Chief Medical Officer & Vice President of Research and Development at Daiichi Asubio Pharmaceuticals, and the Vice President, Medical Affairs at Yamanouchi Pharmaceuticals. He is the author of over 50 scientific publications and has lectured at the Columbia University School of Medicine as well as Johns Hopkins Center for Biotechnology. Dr. Zimmerman received his B.A. in Biophysics from the Johns Hopkins University and his MD from the University of Medicine and Dentistry of New Jersey in 1986, where he continues to teach as adjunct faculty. “I am honored to join the team during this truly exciting time in the Remedy’s history,” said Dr. Zimmerman. “Joining Remedy offers an incredible opportunity to play a pivotal role in bringing an exciting drug to market while working to accelerate Remedy’s diversified efforts in other CNS-related conditions, such as spinal cord injury, traumatic brain injury, and subarachnoid hemorrhage.” ABOUT CIRARA™ CIRARA™ is a patented, high affinity inhibitor of Sur1-Trpm4 channels, discovered by University of Maryland neurosurgeon Dr. J. Marc Simard. 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, traumatic brain injury, spinal cord injury, as well as other ischemic injuries and neurological disorders. Contact: Remedy Pharmaceuticals Sven Jacobson 212-586-2226 x 225 sven@remedypharmaceuticals.com |
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