BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Edge Therapeutics, a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies capable of transforming the treatment of acute, life-threatening neurological conditions, today announced that Renu Vaish, M.S. has been appointed Vice President, Global Regulatory Affairs, effective January 5, 2015. Ms. Vaish will direct the Company's worldwide regulatory strategy and initiatives and will report directly to Edge's Chief Executive Officer, Brian Leuthner.
"We are pleased to have Renu join our team. Her proven track record in leading regulatory affairs for several top-notch global biotechnology franchises is invaluable to Edge as we initiate plans to advance EG-1962 into Phase 3 clinical trials in 2015," said Brian Leuthner, President and Chief Executive Officer of Edge Therapeutics. "As the newest member of our senior management team, Ms. Vaish will play a pivotal role in EG-1962's late stage clinical development and regulatory approval as we strive to improve outcomes in patients who experience aneurysmal subarachnoid hemorrhage."
Ms. Vaish brings nearly 20 years of pharmaceutical and biotechnology experience in regulatory affairs to Edge Therapeutics and has held multiple positions of increasing responsibility at Sanofi-Aventis, Centocor, Genzyme, Millennium Pharmaceuticals, Amgen and Celgene. Most recently she was Executive Director, Global Regulatory Affairs at Celgene Pharmaceuticals, Inc. As the global franchise leader for the company's solid tumor development programs, Ms. Vaish had direct oversight for implementing regulatory strategies for both early and late stage clinical programs, including expanding the global indications and approvals for ABRAXANE®. Additionally, she served on due diligence teams and was part of multiple Joint Steering committees with external partners providing strategic input on key development programs. Ms Vaish has a Master's degree in Regulatory Affairs and Health Policy from the Massachusetts College of Pharmacy and Allied Health Sciences and a Bachelor's degree in cell and molecular biology from Concordia University.
Edge Therapeutics is currently enrolling patients in its NEWTON (Nimodipine microparticles to Enhance recovery While reducing TOxicity after subarachNoid hemorrhage) study, a multicenter, randomized, controlled, open-label, Phase 1/2 clinical trial of its lead product candidate EG-1962. The NEWTON study is evaluating the safety, tolerability and pharmacokinetics of EG-1962 compared to the current standard of care, oral nimodipine, in patients with aneurysmal subarachnoid hemorrhage (aSAH). Edge is also investigating a second compound, EG-1964, for prevention of recurrence of chronic subdural hematoma. The company plans to submit an IND for that treatment in 2015.
About Edge Therapeutics, Inc.
Edge Therapeutics is a clinical-stage biotechnology company that discovers, develops and seeks to commercialize novel, hospital-based therapies capable of transforming treatment paradigms in the management of acute, life-threatening neurological conditions. EG-1962, our lead product candidate, has the potential to fundamentally improve patient outcomes and transform the management of aneurysmal subarachnoid hemorrhage, or aSAH, which is bleeding around the brain due to a ruptured brain aneurysm. EG-1964, our second product candidate, is being evaluated as a potential prophylactic treatment in the management of chronic subdural hematoma, to prevent recurrent bleeding on the surface of the brain.
For additional information about Edge Therapeutics, please visit www.edgetherapeutics.com.
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).