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BERKELEY HEIGHTS, N.J., Feb. 17, 2017 -- Edge Therapeutics, Inc. (Nasdaq:EDGE), a clinical-stage biotechnology company developing novel hospital-based therapies in the management of acute, life-threatening conditions, today announced that two posters on Edge’s lead product candidate, EG-1962, will be presented at the International Stroke Conference (ISC) 2017 to be held February 22-24, 2017 in Houston, Texas.
EG-1962, is currently being investigated in the pivotal Phase 3 NEWTON 2 (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) clinical study comparing the efficacy and safety of EG-1962 administered through an external ventricular drain (EVD) compared to oral nimodipine in adults who suffer an aneurysmal subarachnoid hemorrhage (aSAH) resulting from a ruptured brain aneurysm.
Details of the presentations are as follows:
Title: CTP29 - NEWTON 2: Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group, Efficacy and Safety Study Comparing EG-1962 to Standard of Care Oral Nimodipine in Adults with Aneurysmal Subarachnoid Hemorrhage
Session: CT P1 - Ongoing Clinical Trials Posters II
Date / Time: Thursday, February 23, 6:15 - 6:45 p.m. Central Time
Location: Hall E
Presenter: Daniel Hänggi, M.D., University Medical Center Mannheim, Ruprecht-Karls-University, Heidelberg, Germany
Title: TP425 - How do Different Outcome Measures Reflect Outcome After Aneurysmal Subarachnoid Hemorrhage
Session: P35 - SAH and Other Neurocritical Management Posters II
Date / Time: Thursday, February 23, 6:15 - 6:45 p.m. Central Time
Location: Hall E
Presenter: Daniel Hänggi, M.D., University Medical Center Mannheim, Ruprecht-Karls-University, Heidelberg, Germany
For additional information, please visit the ISC website.
About EG-1962
EG-1962 is a novel polymeric nimodipine microparticle containing nimodipine suspended in a diluent of sodium hyaluronate. EG-1962 utilizes Edge’s proprietary PrecisaTM development platform and is designed to improve patient outcomes following aSAH. EG-1962 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA), and orphan drug designation by the FDA and the European Commission.
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 and other conditions. EG-1962, Edge’s lead product candidate, has the potential to fundamentally improve patient outcomes and transform the management of aneurysmal subarachnoid hemorrhage, which is bleeding around the brain due to a ruptured brain aneurysm. Edge is evaluating EG-1962 in two clinical studies: the pivotal Phase 3 NEWTON 2 study of EG-1962 delivered via external ventricular drain, and a study of direct intracisternal administration of EG-1962. 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 future clinical plans, 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]
