Findings To Be Presented At Vasospasm 2013, The 12th International Conference On
Neurovascular Events After Subarachnoid Hemorrhage
NEW PROVIDENCE, N.J. & DUSSELDORF, Germany--(BUSINESS WIRE)-- Edge Therapeutics
announced today positive preliminary results from the first human use of
EG-1962, the Company's novel bioabsorbable nimodipine microparticle formulation
for the prevention of delayed cerebral ischemia (DCI), a life-threatening
complication of subarachnoid hemorrhage (SAH), typically resulting from a
ruptured brain aneurysm or traumatic brain injury. There are approximately
90,000 patients in North America and Europe who are at risk for DCI, most of
whom would be candidates for EG-1962.
Researchers at Heinrich-Heine-University Hospital in Dusseldorf, Germany
conducted an open-label study to assess the safety and tolerability of EG-1962,
which delivers therapeutic and sustained concentrations of nimodipine directly
to the site of brain injury. Eleven patients were treated and 10 met pre-defined
enrollment criteria, which included a low level of consciousness on admission to
the emergency room and high hemorrhage volumes. Investigators found that there
were no adverse events or other safety concerns related to EG-1962.
Additionally, good clinical outcome, as measured by the Glasgow Outcome Scale
(GOS) 30 days after SAH, was observed in all 10 patients who met the enrollment
criteria. Based on similar patients treated in past clinical studies,
researchers would have expected approximately half of these patients to suffer a
poor outcome, such as death, persistent vegetative state or severe disability.
An oral presentation of these data is scheduled during Vasospasm 2013, the 12th
International Conference on Neurovascular Events after Subarachnoid Hemorrhage,
on Fri., July 12, 2013 in Lucerne, Switzerland.
"Our early clinical experience shows that one-time administration of EG-1962 has
the potential to prevent a major cause of death or permanent disability after
SAH," said Daniel Hanggi, M.D., principal investigator of the study and Vice
Chairman of the Department of Neurosurgery at Heinrich-Heine-University. "We are
eager to participate in further research to investigate this promising and
potentially life-saving therapy in our new investigator-initiated study under
the auspices of the Bundesinstitut fur Arzneimittel und Medizinprodukte (BfArM,
the German Institute for Drugs and Medical Devices)."
"The early clinical results and lack of side-effects with EG-1962 are striking,"
noted R. Loch Macdonald, M.D., Ph.D., Head of the Division of Neurosurgery and
Keenan Endowed chair in Surgery at St. Michael's Hospital in Toronto, Ontario,
Canada, and Chief Scientific Officer of Edge Therapeutics. "Given these positive
early results, EG-1962 may provide physicians with a powerful tool to reduce the
risk of poor outcomes that threaten these already vulnerable patients."
Nimodipine is the standard of care for the prevention of DCI worldwide. However,
many researchers believe currently approved oral and intravenous formulations of
nimodipine deliver sub-optimal concentrations to the site of brain injury and
have shown only modest efficacy in reducing poor outcomes after aneurysmal SAH.
Previous efforts to administer higher doses of nimodipine have been limited by
serious side effects such as hypotension.
"Despite efforts to prevent DCI, many patients continue to suffer a secondary
stroke or even death 3 to 14 days after their hemorrhage," said Brian Leuthner,
President and CEO of Edge Therapeutics. "The average age of patients who develop
DCI is 50 years old and their complications are often catastrophic. There have
been no approved therapies for DCI in almost 25 years, and we are hopeful that
EG-1962 might one day become a new treatment option for these patients."
Edge announced earlier this month that the U.S. Food and Drug Administration
(FDA) has accepted the Company's Investigational New Drug (IND) application for
EG-1962. The opening of the lND will allow the company to begin enrolling
patients in a Phase 1/2 clinical trial evaluating the safety and tolerability of
EG-1962 for prevention of DCI. The multinational Phase 1/2 trial, expected to
commence in the third quarter of 2013, is to be conducted separately from the
Heinrich-Heine-University investigator-initiated study, and will include up to
96 patients in approximately 20 centers in North America and Europe.
About Delayed Cerebral Ischemia
Delayed cerebral ischemia (DCI) is a delayed, life-threatening neurological
condition that occurs as a result of SAH, which is most commonly caused by
aneurysmal SAH or traumatic brain injury (TBI). DCI is a major cause of death
and disability in patients who are treated in the hospital for SAH.1,2,3
According to the World Health Organization and the International Brain Injury
Association, at least two million people each year suffer conditions that put
them at risk for DCI. DCI commonly affects the working population (average age
50 years old) and occurs in approximately one-third of patients during the first
two weeks after SAH, often resulting in substantial disability or death.1
About Edge Therapeutics, Inc.
Edge Therapeutics, Inc. is a private, clinical-stage biopharmaceutical 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
formulations release drugs 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, oral- or IV-administered therapies are employed in
suboptimal concentrations due to the generation of systemic side effects. Edge's
lead product candidates, EG-1962 (nimodipine microparticles) and EG-1964, are
being developed to prevent various delayed complications after brain hemorrhage.
EG-1962 is a proprietary microparticle formulation of the calcium channel
blocker nimodipine, while EG-1964 delivers a hemostatic agent. For more
information on Edge Therapeutics, Inc., please visit: www.edgetherapeutics.com.
About Heinrich-Heine-University Hospital Dusseldorf
Heinrich-Heine-University Hospital Dusseldorf is a teaching hospital with
specialty areas in neurosciences, cardiology and vascular medicine, diabetes
mellitus, environmental medicine, hepatology, infection biology and molecular
biology of aging. More than 190,000 patients are treated annually at the
university's 30 clinics and 31 institutes. The close integration of patient
care, research and medical training in one place presents decisive advantages
for the patient - as well as for the medical students.
Medical research at a university is fundamental, disease-oriented and
patient-oriented, and is a result of the university clinic and the medical
faculty of Heinrich-Heine-University working closely together towards constant
improvement in our understanding of illness. This is the basis for new methods
in diagnostics and therapy that are regularly tested in supraregional clinical
studies and are made available to the patient as rapidly as possible. For more
information, please visit: www.uni-duesseldorf.de.
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.
1 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.
2 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.
3 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.
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Edge Therapeutics, Inc.
Brian A. Leuthner, 800-208-EDGE
President & CEO
Jennifer Devine, 973-442-1555 ext. 102
Source: Edge Therapeutics, Inc.