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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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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 PRESS RELEASE
Remedy Pharmaceuticals Appoints Thomas MacAllister as Vice President of Research and Development and General Counsel NEW YORK, New York, March 15, 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 the Company appointed Thomas MacAllister as Vice President of Research and Development, and General Counsel. “As we begin preparations for commencement later this year of our Phase 3 clinical trial in patients with large hemispheric stroke, Tom’s wealth of CNS-related clinical trial experience will be indispensable,” states Sven Jacobson, CEO of Remedy Pharmaceuticals. “We’re therefore delighted to welcome him to the senior management team.” Thomas MacAllister, Ph.D., JD, has over 25 years of experience in business development, preclinical and clinical development, regulatory strategy, intellectual property and commercialization. He has assembled and led a team that took a program for severe traumatic brain injury from concept through the completion of a Phase 3 clinical trial. Prior to joining Remedy Pharmaceuticals, Dr. MacAllister served as the Chief Executive Officer of Argentum Pharmaceuticals, for whom he developed new business models to reduce the cost of drugs to the healthcare system. He also served as Chief Executive Officer and General Counsel at BHR Pharma and Chief Development Officer at Besins Healthcare SA where he was primarily focused on drug development and oversaw research and development and the intellectual property department. He is an attorney licensed to practice law in the Commonwealth of Virginia, the District of Columbia and before the United States Patent & Trademark Office. “I am excited to join the Remedy Pharmaceuticals at this pivotal time,” notes Thomas MacAllister. “I believe that the Company’s lead product, CIRARA, represents a significant opportunity to define the treatment of CNS-related edema, and thus save and improve the lives of countless patients for whom there are currently no effective therapies. I look forward to helping advance this novel compound through clinical development.” 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 stroke, 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 PRESS RELEASE
Remedy Pharmaceuticals Announces Successful Completion of End-of-Phase 2 Meeting with FDA On A Novel Drug Treatment For CNS-Related Edema NEW YORK, New York, March 4, 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 successful completion of an End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), which took place on March 2, 2016. “Our End-of-Phase 2 meeting was a decisive milestone for the Company as we advance the clinical development of CIRARA™,” states Sven Jacobson, Chief Executive Officer of Remedy Pharmaceuticals. “We are pleased with the FDA’s guidance on our Phase 3 trial design in patients with large hemispheric stroke and we look forward to initiating the study as quickly as possible.” “There is a major unmet medical need to treat CNS-related edema,” said David Geliebter, Executive Chairman of Remedy Pharmaceuticals. “The encouraging data from our Phase 2 studies suggest CIRARA has the potential to reduce mortality and improve functional outcomes for patients with large hemispheric strokes. We’re now one step closer to achieving that goal.” 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™ measured phase dosing 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 stroke, 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 Investors Lee Roth / Tram Bui, The Ruth Group 646-536-7012 / 646-536-7035 lroth@theruthgroup.com / tbui@theruthgroup.com Media Kirsten Thomas, The Ruth Group 508-280-6592 kthomas@theruthgroup.com PRESS RELEASE
Remedy Pharmaceuticals Announces Additional Results from Phase 2 CNS-Related Edema Study of CIRARA™ Presented at International Stroke Conference A more than three-fold reduction in mortality in patients ≤70 years old; adjudicated neurological mortality reduced more than three-fold, and death from edema reduced 10-fold. Results Provide Additional Basis for Planned U.S. Phase 3 Trial in Large Hemispheric Stroke NEW YORK, New York, February 22, 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 additional efficacy data from its Phase 2 trial of CIRARA™ for preventing edema (brain swelling) in patients with large hemispheric stroke. The results were presented by the study’s two principal investigators, Kevin N. Sheth, MD of Yale University and W. Taylor Kimberly, MD of Massachusetts General Hospital, in two oral presentations during the International Stroke Conference (ISC) 2016, held February 17-19, 2016 at the Los Angeles Convention Center in Los Angeles, California. CIRARA is the Company’s lead product candidate for the treatment of CNS-related edema. The GAMES-RP study was a prospective double-blind, randomized, placebo-controlled Phase 2 trial comparing CIRARA to placebo. Top line results had previously been presented at the Neurocritical Care Society annual general meeting in October 2015 and announced by Remedy in a press release. The additional analyses presented at ISC included adjudicated mortality, 6-month functional outcome data, and a post hoc analysis in patients 70 years or younger. Adjudicated neurological mortality was reduced from 25% in placebo to 7% in CIRARA-treated patients (p=0.03), a more than three-fold reduction in mortality, and death from edema (swelling) was reduced from 22% in placebo to 2% in CIRARA-treated patient (p=0.008), or a ten-fold decrease. In a pre-specified “shift analysis”, there was a trend towards improved 6-month functional (modified Rankin Scale or mRS) scores (p=0.13). The sizable reduction in mortality exhibited at 90 days remained at six months (39% in placebo versus 20% in the CIRARA group, p=0.06). In patients 70 and younger, 90-day functional outcomes were statistically significantly improved across the board (p=0.048), and 90-day mortality was dramatically reduced from 33% in the placebo group to 12% in the CIRARA group (p=0.03). This difference persisted at six months (37% vs. 14%, p=0.04). Sven Jacobson, CEO of Remedy Pharmaceuticals, said, “This exciting six-month data shows a continued reduction in mortality and improvement in functional scores, the adjudicated mortality data further confirms the mechanism of action of CIRARA, and the robust signal in patients 70 and under suggests an even larger effect in younger patients. This additional data is very helpful as we move forward with the design of our planned Phase 3 trial.” 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. 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 stroke, 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 Investors Lee Roth / Tram Bui, The Ruth Group 646-536-7012 / 646-536-7035 lroth@theruthgroup.com / tbui@theruthgroup.com Media Kirsten Thomas, The Ruth Group 508-280-6592 kthomas@theruthgroup.com PRESS RELEASE
Remedy Pharmaceuticals Announces FDA Orphan Drug Designation in Two CNS Indications Investigational Drug CIRARA™ Receives Orphan Drug Designation in Both Acute Subarachnoid Hemorrhage and Acute Spinal Cord Injury NEW YORK, New York, February 16, 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 the United States Food and Drug Administration (“FDA”) has granted orphan drug designation to its lead drug, CIRARA™, for both the treatment of acute subarachnoid hemorrhage and acute spinal cord injury. Subarachnoid hemorrhage (SAH) is a life-threatening form of a stroke characterized by increased pressure on the brain due to blood and fluid buildup in the subarachnoid space. It is estimated that up to 30,000 people per year suffer from SAH in the United States. A Phase II pilot study evaluating CIRARA™ as a treatment for SAH patients is planned to begin in the second half of this year. Spinal cord injury (SCI) is a condition resulting from trauma or damage to the spinal cord leading to loss or impaired function causing reduced mobility or sensation. Approximately 12,000 new cases of SCI occur in the United States each year. Remedy Pharmaceuticals initiated enrollment for a Phase II pilot study of CIRARA™ in SCI patients in the last quarter of 2015. “We are pleased to receive the orphan drug designation for CIRARA™ for both acute subarachnoid hemorrhage and acute spinal cord injury,” notes Sven M. Jacobson, Co-Founder and Chief Executive Officer of Remedy Pharmaceuticals. “This represents two key regulatory milestones for the company and takes us a giant step closer to advancing a treatment that we believe holds great promise for patients suffering from these devastating conditions.” The Orphan Drug Designation program offers a distinctive status to investigational drugs and biologics being tested to treat, diagnose or prevent diseases and disorders that affect less than 200,000 people in the U.S. This designation makes the company eligible for a seven year marketing exclusivity period against market competitors. In addition, it provides certain incentives, including federal grants, tax credits and a waiver of PDUFA filing fees. ABOUT CIRARA™ CIRARA™ is a high affinity inhibitor of Sur1-Trpm4 channels, which are upregulated in ischemic and traumatic events. CIRARA is designed to close these channels and thus prevent or reduce edema in a variety of CNS-related indications. CIRARA uses the company’s proprietary, patented MPD™ technology. CIRARA is an investigational drug and is not approved by FDA. ABOUT REMEDY PHARMACEUTICALS Remedy Pharmaceuticals is a privately-held, phase 3 ready, acute care pharmaceutical company. We are focused on bringing life saving hospital-based treatments to people afflicted by central nervous system-related edema. In a randomized, double-blind phase 2 study in large hemispheric stroke patients, CIRARA reduced mortality as well as improved functional outcomes, based on modified Rankin Scale (mRS) scores. Contact: Remedy Pharmaceuticals Sven Jacobson 212-586-2226 x 225 sven@remedypharmaceuticals.com Investors Lee Roth / Tram Bui, The Ruth Group 646-536-7012 / 646-536-7035 lroth@theruthgroup.com / tbui@theruthgroup.com Media Kirsten Thomas, The Ruth Group 508-280-6592 kthomas@theruthgroup.com PRESS RELEASE
Remedy Pharmaceuticals Announces Acceptance of Two Oral Presentations on Phase 2 Results of CIRARA™ for CNS-Related Edema at ISC 2016 Presentations by Principal Investigators at Yale University and Massachusetts General Hospital NEW YORK, New York, February 8, 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 ischemic strokes will be presented during two oral presentations at the upcoming International Stroke Conference (ISC) 2016, being held February 17-19, 2016 at the Los Angeles Convention Center in Los Angeles, California. The two oral presentations will be conducted by principal investigators and leading neuroscience researchers at Yale University and Massachusetts General Hospital. “We are thrilled to have this exciting data presented to a group of illustrious clinicians at the world’s largest and most prestigious medical meeting dedicated to the science and treatment of cerebrovascular disease,” commented Sven Jacobson, CEO of Remedy Pharmaceuticals. “Edema is one of the most significant mortality risks associated with stroke and other acute CNS conditions. In fact, in the first week following an ischemic stroke, 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 sharing the full results of the Phase 2 trial evaluating CIRARA for reduction of the devastating consequences associated with edema after a severe stroke.” Logistical details for the two oral presentations include: Abstract LB6: GAMES (Glyburide Advantage in Malignant Edema and Stroke) RP Trial: 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; Chief, Clinical Research, Department of Neurology; Yale University, New Haven, CT Session: A34 – Late-Breaking Science Oral Abstracts I Date: Wednesday, February 17, 2016 Time: 4:06 – 4:18 pm PT Location: Room 408 Abstract LB24: GAMES (Glyburide Advantage in Malignant Edema and Stroke) RP: Intermediate Endpoint Analysis as Proof-of-Concept Presenting Author: W. Taylor Kimberly, MD, PhD Associate Director, Neuroscience Intensive Care Unit; Massachusetts General Hospital; Assistant Professor of Neurology; Harvard Medical School, Boston, MA Session: Plenary Session III Date: Friday, February 19, 2016 Time: 12:17 – 12:29 pm PT Location: Hall K Remedy will be available to meet with potential Phase 3 clinical sites and other interested parties at Booth #629 in the Science and Technology (Exhibit) Hall. The International Stroke Conference is the world’s largest medical meeting dedicated to the science and treatment of cerebrovascular disease. This 2½-day conference features more than 1,500 presentations that emphasize basic, clinical and translational sciences as they evolve toward a more complete understanding of stroke pathophysiology with the overall goal of developing more effective prevention and treatment. 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. 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 stroke, 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 Investors Lee Roth / Tram Bui, The Ruth Group 646-536-7012 / 646-536-7035 lroth@theruthgroup.com / tbui@theruthgroup.com Media Kirsten Thomas, The Ruth Group 508-280-6592 kthomas@theruthgroup.com PRESS RELEASE
CNS-RELATED EDEMA COMPANY REMEDY PHARMACEUTICALS STRENGTHENS LEADERSHIP TEAM IN PREPARATION FOR PHASE 3 TRIAL NEW YORK, New York, January 5, 2016 — Remedy Pharmaceuticals, a clinical stage pharmaceutical company focused on the development and commercialization of an innovative central nervous system drug, CIRARA™, announced today that the Company strengthened its leadership team with the appointment of Ann Tunstall as Vice President of Regulatory and Operational Affairs, and Alan Cutler as Vice President of Chemistry Manufacturing and Controls. "We’re excited to have Ann and Alan join our executive team,” commented Sven Jacobson, CEO of Remedy Pharmaceuticals. “They bring a wealth of experience and tremendous knowledge, which we believe will be a great asset to the company as we move closer to initiating our Phase 3 trial targeting brain swelling following severe stroke. We also look forward to their contributions as we accelerate our clinical trial efforts in other CNS conditions where swelling is an important determinant of outcome such as spinal cord injury, traumatic brain injury and subarachnoid hemorrhage.” Ann Tunstall has 25 years of experience in the healthcare industry, identifying and implementing effective regulatory and clinical development strategies for novel and repositioned pharmaceuticals and combination products. Her experience covers a wide range of therapeutic areas, with a particular focus on neurological indications. Dr. Tunstall has a Ph.D. in Biomedical Engineering from the University of Texas Southwestern Medical Center, an M.S. in Material Science from Duke University, and a B.S. in Biomedical Engineering from Duke University. Alan Cutler has over two decades of successful product research and development and commercialization experience. Previously, he held the position of Vice President of Research and Development and Chief Scientific Officer at Three Rivers Pharmaceuticals, LLC (now Kadmon Pharmaceuticals, LLC), Senior Director of Research and Development at Ascend Therapeutics, and Senior Project Leader at DSM Pharmaceuticals Inc. Dr. Cutler also spent 18 years in various R&D and global project-leadership positions at 3M. He received his Bachelor’s Degree in Chemistry from SUNY at Buffalo and his Doctoral Degree from the University of East Anglia’s School of Chemical Sciences. ABOUT CIRARA CIRARA is a patented, high affinity inhibitor of Sur1-Trpm4 channels. Sur1-Trpm4 channels are upregulated following ischemia and open due to ATP depletion resulting in sodium influx, which is followed by water that leads to cell swelling, damage and death. Dysfunction of endothelial cells through this mechanism results in blood brain barrier disruption which allows fluids to cross into the brain, i.e., brain swelling. CIRARA is suitable for intravenous delivery at the bedside or even in an ambulance. CIRARA uses a proprietary, patented MPD™ technology for drug delivery. CIRARA is an investigational drug and is not approved by FDA. ABOUT REMEDY PHARMACEUTICALS Remedy Pharmaceuticals is a privately-held, clinical stage pharmaceutical company focused on bringing life saving hospital-based treatment to people affected by central nervous system (CNS) related edema, which can occur in ischemic stroke, traumatic brain injury, subarachnoid hemorrhage, spinal cord injury, intracerebral hemorrhage, and following neurosurgery, as well as in other ischemic and traumatic CNS injuries. Contact: Sven Jacobson 212-586-2226 x 225 sven@remedypharmaceuticals.com PRESS RELEASE
REMEDY PHARMACEUTICALS TO PRESENT AT THE OPPENHEIMER 26th ANNUAL HEALTHCARE CONFERENCE NEW YORK, December 2, 2015 — Remedy Pharmaceuticals, a clinical stage pharmaceutical company focused on the development and commercialization of an innovative drug, CIRARA™, announced today that the Company will be presenting at the Oppenheimer 26th Annual Healthcare Conference to be held at the Westin Grand Central in New York City on December 8 – 9, 2015. Sven Jacobson, Remedy Pharmaceuticals’ Chief Executive Officer, will present a formal company presentation, followed by a Q&A session, on Tuesday, December 8th in the Consulate Room at 9:10am – 9:40am ET. 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. CIRARA is an investigational drug for severe stroke and is not approved by FDA. 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 |
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