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Prevention of Delayed Cerebral Ischemia after Aneurysmal Subarachnoid Hemorrhage Reported in First Clinical Application of EG-1962
NEW PROVIDENCE, N.J.--(BUSINESS WIRE)--
Edge Therapeutics today announced that researchers from Heinrich Heine
University in Düsseldorf, Germany presented positive results of the
first clinical application of EG-1962 (nimodipine microparticles), a
sustained release injectable formulation of nimodipine for improvement
of outcome and prevention of delayed cerebral ischemia (DCI) after
aneurysmal subarachnoid hemorrhage (SAH). The results were featured in
an oral presentation at Vasospasm 2013, the 12th International
Conference on Neurovascular Events after Subarachnoid Hemorrhage in
Lucerne, Switzerland, a meeting that attracts hundreds of prominent
neurovascular specialists from around the world.
SAH is a life-threatening form of hemorrhagic stroke that typically
results from a ruptured brain aneurysm or traumatic brain injury and is
often complicated by DCI, which has a high likelihood of causing death
or disability. There are approximately 90,000 patients in North America
and Europe who are at risk for DCI following aneurysmal SAH, most of
whom would be candidates for EG-1962.
“Despite clinicians’ best efforts to prevent permanent disability or
death during the course of aneurysmal SAH, the effective reduction of
DCI and poor functional outcome remains challenging,” commented Daniel
Hänggi, M.D., principal investigator of the study and Vice Chairman of
the Department of Neurosurgery at Heinrich Heine University. “EG-1962
appears to be a promising new approach to preventing DCI, based on the
results from this initial group of patients,” added Nima Etminan, M.D.,
co-principal investigator and staff neurosurgeon at Heinrich Heine
University.
Dr. Etminan presented data from their open-label study in which 11
patients received one-time administration of EG-1962 in doses ranging
from 40 mg to 400 mg. Ten of the patients met the study’s enrollment
criteria, which included documented severe aneurysmal SAH and treatment
within 48 hours of aneurysm rupture. No EG-1962-related adverse events,
such as toxic drug effects or systemic hypotension, were reported for
any patients. In patient No. 1, who received the 40-mg dose, levels of
nimodipine in the plasma and cerebrospinal fluid (CSF) were suboptimal,
whereas for patients treated with the 100-mg dose or higher, plasma and
CSF levels of nimodipine were within the therapeutic range over the
analyzed period. No patients meeting enrollment criteria who received
the 100-mg dose or higher demonstrated any clinical or radiological
features of DCI or cerebral infarction on computed tomography (CT)
imaging. After 6 weeks post-SAH, all patients meeting enrollment
criteria were rated a 5 (good recovery) on the 5-point Glasgow Outcome
Scale (GOS), a measure of outcome after head injury and nontraumatic
acute brain insults. One patient was treated after more than 48 hours of
aneurysm rupture and was a protocol deviation. This patient died due to
the natural course of aneurysmal SAH unrelated to EG-1962 administration.
“We are greatly encouraged by the apparent prevention of DCI and
improvement in outcome, as well as by the lack of side effects in this
initial study of EG-1962,” said Dr. Hänggi, “We hope to see these
results replicated in additional studies.”
Last month Edge announced 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, will include up to 96 patients in approximately 20 centers in
North America and Europe. Dr. Hänggi, M.D. will serve as principal
investigator for this study.
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 bioabsorbable
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.
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subject to significant risks and uncertainties. Actual results may
differ significantly from those set forth in the forward-looking
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uncertainties that are subject to change based on various factors (many
of which are beyond the Company’s control). The Company undertakes no
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a result of new information, future events or otherwise, except as
required by applicable law.
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