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BERKELEY HEIGHTS, N.J., Sept. 01, 2016 -- Edge Therapeutics, Inc. (Nasdaq:EDGE), a clinical-stage biotechnology company developing novel hospital-based therapies for the management of acute, life-threatening conditions, today announced that additional data from its completed North American Phase 1/2 NEWTON (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) study of EG-1962 will be presented in an oral session at the European Association of Neurosurgical Societies 16th European Congress of Neurosurgery (EANS 2016) and in a poster session at the Neurocritical Care Society 14th Annual Meeting, both to be held in September 2016. Previously disclosed data from the NEWTON study will also be presented at each conference.
EG-1962, Edge’s lead product candidate, is currently being investigated in the pivotal Phase 3 NEWTON 2 clinical study comparing the efficacy and safety of EG-1962 to standard of care oral nimodipine in adults who suffer an aneurysmal subarachnoid hemorrhage (aSAH) resulting from a ruptured brain aneurysm.
Details of the presentations are as follows:
EANS 2016
Date: September 4-8
Location: Megaron Athens International Conference Centre, Athens, Greece
Presenter: Daniel Hänggi, M.D., Chairman of Neurosurgery at the University Medical Center Mannheim, Ruprecht-Karls-University, Heidelberg, Germany
- Oral presentation: “Pharmacokinetics and Health Economics of Intraventricular Sustained Release Nimodipine (EG-1962) for Subarachnoid Hemorrhage”
- Abstract Number: 1026
- Date / location: Tuesday, September 6, from 18:06 – 18:12 EEST / 11:06 – 11:12 a.m. EDT in room MC 3
- ePoster presentation: “Safety, Tolerability, Pharmacokinetics and Efficacy of Intraventricular Sustained Release Nimodipine (EG-1962) for Subarachnoid Hemorrhage”
- ePoster on display during the EANS meeting from September 4 - 8
For additional information, please visit: http://eans2016.com/.
Neurocritical Care Society 14th Annual Meeting
Date: September 15-18
Location: Gaylord National Resort & Convention Center, National Harbor, MD
Presenter: Daniel Hänggi, M.D., Chairman of Neurosurgery at the University Medical Center Mannheim, Ruprecht-Karls-University, Heidelberg, Germany
- Poster presentation: “Pharmacokinetics and Health Economics of Intraventricular Sustained Release Nimodipine (EG-1962) for subarachnoid hemorrhage”
- Abstract Number: 181
- Date / location: Saturday, September 17, from 5:30 – 6:30 p.m. EDT in Exhibit Hall A
- Oral presentation: “Safety, Tolerability, Pharmacokinetics and Efficacy of Intraventricular Sustained Release Nimodipine (EG-1962) for Subarachnoid Hemorrhage”
- Session: Platform Presentation Session 2
- Date / location: Saturday, September 17, from 4:50 to 5:00 p.m. EDT in Prince George Exhibit Hall
For additional information, please visit: http://www.neurocriticalcare.org/Meetings/2016-Annual-Meeting.
Disclosure: Dr. Hänggi is a consultant for Edge Therapeutics and a member of the company’s clinical and scientific advisory committees.
About EG-1962
EG-1962 is a novel polymeric nimodipine microparticle suspended in a diluent of hyaluronic acid that utilizes Edge Therapeutics’ proprietary PrecisaTM development platform designed to improve patient outcomes following an aSAH. EG-1962 has been granted orphan drug designation and Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment of patients with subarachnoid hemorrhage, and orphan drug designation by the European Commission (EC) for the treatment of patients with aSAH.
About aSAH
An aneurysmal subarachnoid hemorrhage is a brain hemorrhage after which blood from a ruptured aneurysm enters the subarachnoid space, the area between the middle and deepest protective layers of the brain. Approximately 600,000 individuals worldwide suffer an aSAH annually. In the U.S., approximately 35,000 aSAH patients, with an average age of 52, arrive alive at the hospital each year, and approximately 75 percent of these patients die or suffer permanent brain damage.
About Edge Therapeutics, Inc.
Edge Therapeutics, Inc. is a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies capable of transforming treatment paradigms for the management of acute, life-threatening neurological conditions. EG-1962, Edge’s lead product candidate, has the potential to fundamentally improve patient outcomes and transform the management of an aSAH, which is bleeding around the brain due to a ruptured brain aneurysm. For additional information about Edge, please visit www.edgetherapeutics.com.
Forward-Looking Statements
This press release and any statements of representatives of Edge Therapeutics, Inc. related thereto that are not historical in nature contain, or may contain, among other things, certain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements may include, without limitation, statements with respect to Edge’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," “seeks,” "intends," "plans," "potential" or similar expressions, including statements with respect to Edge’s ability to advance its portfolio of therapies towards commercialization and the potential effects of its products. These statements are based upon the current beliefs and expectations of Edge’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 risk factors (many of which are beyond Edge's control) as described under the heading "Risk Factors" in Edge’s filings with the United States Securities and Exchange Commission.
Investor Contact: Gregory Gin Edge Therapeutics, Inc. Tel: 1-800-208-EDGE (3343) Email: [email protected] Media Contact: Laura Bagby 6 Degrees Tel: 312-448-8098 Email: [email protected]
