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.
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).
Copyright Business Wire 2015