Edge Therapeutics Enrolls First Patient in Phase 1/2 NEWTON Study of EG-1962 for Prevention of Delayed Cerebral Ischemia
October 30, 2013
Randomized, Open-Label, International, Multi-center Study Comparing EG-1962 To Oral Nimodipine
NEW PROVIDENCE, N.J. – October 30, 2013 – Edge Therapeutics, a clinical-stage biotechnology company focused on developing and commercializing life-saving hospital products for acute, fatal or debilitating conditions, announced today, enrollment of the first patient in the NEWTON study, a multicenter Phase 1/2 randomized, open-label, controlled clinical study of its lead product, EG-1962 at the University of Maryland Medical Center site in Baltimore, Maryland. The study is evaluating the safety, tolerability, and pharmacokinetics of EG-1962 compared to the current standard of care, oral nimodipine after subarachnoid hemorrhage (SAH). Exploratory endpoints will assess the ability of EG-1962 to reduce delayed cerebral ischemia (DCI) and improve clinical outcome compared to oral nimodipine.
EG-1962 is a novel polymeric nimodipine microparticle that is administered directly into the brain ventricles as a single dose and releases the drug at the site of brain injury over 21-days. EG-1962 is being developed to improve patient outcome by preventing DCI, a life-threatening complication of SAH that typically results from a ruptured brain aneurysm or traumatic brain injury (TBI).
“DCI is a very serious, yet potentially preventable complication of subarachnoid hemorrhage,” said E. Francois Aldrich, M.D., study investigator and an Associate Professor of Neurosurgery, Vice Chair, Department of Neurosurgery, University of Maryland, Program Director of the Neurosurgery residency program and the Chief of Cerebrovascular Surgery. “By studying EG-1962 administered by a single intraventricular injection in escalating doses, we hope to select the optimal dose that potentially will prevent this debilitating condition.”
“We are excited to announce the start of the NEWTON study and to treat patients whose lives could be improved with this potential new therapy,” said Dr. R. Loch Macdonald, Chief Scientific Officer at Edge Therapeutics. “We look forward to reporting data in the first half of 2014 and advancing the clinical development of EG-1962.”
The NEWTON (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) study will enroll up to 96 patients in approximately 20 centers internationally. The study will evaluate safety, tolerability, pharmacokinetics, and exploratory efficacy endpoints compared to oral nimodipine in patients with ruptured brain aneurysms. The first part of the study is a dose exploration phase of up to six dosing level cohorts with up to 12 patients per cohort, randomized at a ratio of 3 to 1 to receive either single dose EG-1962 or oral nimodipine. The primary objective of the dose – exploration phase is to establish the dose of EG-1962 to take forward into the next study. The second part of the study is a potential expansion phase allowing for treatment of additional patients to further evaluate the selected dose of EG-1962. Completion of the study is expected in 2014.1
About Delayed Cerebral Ischemia
DCI is a delayed, life-threatening neurological condition that occurs as a result of SAH, and is most commonly caused by aneurysmal SAH or TBI. DCI is a major cause of death and disability in patients who are treated in the hospital for SAH.2,3,4 According to the World Health Organization and the International Brain Injury Association, at least two million people each year suffer from conditions that put them at risk for DCI.
About Edge Therapeutics, Inc.
Edge Therapeutics, Inc. is a private, clinical-stage biotechnology company focused on developing and commercializing life-saving hospital products that improve patient outcome by addressing acute, fatal or debilitating conditions after brain hemorrhage that have no current effective treatment. Edge uses its novel site-specific and sustained-release microparticle technology platform to deliver drugs to the brain to prevent complications of subarachnoid hemorrhage, subdural hematoma and intracerebral hemorrhage, all of which currently have no effective therapies. The Company’s patent-protected bio-absorbable microparticle technology releases medicine locally and consistently at therapeutic concentrations in the brain, with the objective of maximizing therapeutic activity and avoiding treatment-limiting systemic side effects seen with current treatments. Currently, achieving optimal concentrations of oral- or IV-administered therapies can be limited due to systemic side effects. Edge’s lead product candidates, EG-1962 and EG-1964, are being developed to prevent various delayed complications after brain hemorrhage. EG-1962 is a proprietary microparticle product containing the calcium channel blocker nimodipine, while EG-1964 delivers a hemostatic agent. For more information on Edge Therapeutics, Inc., please visit: www.pdsbiotech.com.
Forward Looking Statements
This press release and any statements of representatives and partners of Edge Therapeutics, Inc. (the “Company”) related thereto contain, or may contain, among other things, certain “forward-looking statements” as defined in the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions. These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties. Actual results may differ significantly from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control). The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
For more information contact:
Edge Therapeutics, Inc.
Brian A. Leuthner
President & CEO
973-442-1555 ext. 102
 Clinicaltrials.gov. Safety and tolerability study of EG-1962 in aneurysmal subarachnoid hemorrhage. U.S. National Institutes of Health; 2013. Available at: http://www.clinicaltrials.gov/ct2/show/NCT01893190?term=EG-1962&rank=1. Accessed August 20, 2013.
2 Frontera JA, Fernandez A, Schmidt JM, et al. Defining vasospasm after subarachnoid hemorrhage: what is the most clinically relevant definition? Stroke 2009;40:1963-8.
3 Kassell NF, Torner JC, Haley EC Jr, Jane JA, Adams HP, Kongable GL. The International Cooperative Study on the Timing of Aneurysm Surgery. Part 1: Overall management results. J Neurosurg 1990;73:18-36.
4 Vergouwen MD, de Haan RJ, Vermeulen M, Roos YB. Effect of statin treatment on vasospasm, delayed cerebral ischemia, and functional outcome in patients with aneurysmal subarachnoid hemorrhage: a systematic review and meta-analysis update. Stroke 2010;41:e47-e52.