The Epilepsy Therapy Project (ETP) and the Epilepsy
Foundation (EF) today announced the latest grant recipients of their New
Therapy Grants Program, a unique joint venture of the two non-profit epilepsy
organizations to advance clinical development and commercialization of
promising epilepsy therapies. The grant awards will support the development of
four important new technologies:
- High definition transcranial direct current stimulation
(HD-tDCS) for the treatment of intractable focal status epilepticus; - Optogenetic functional MRI (ofMRI), a revolutionary
technology and proprietary mouse model that directly visualizes in vivo the
actual spread of seizure activity through brain networks and assesses drug
effects; - A dry electrode headset that records brain waves (EEG)
without requiring extensive, time-consuming and uncomfortable patient
preparation, potentially offering significant improvements in care and outcomes
for patients in emergency and intensive care units; and - A wireless EEG device designed as a dermal “patch” applied
to the scalp to unobtrusively track seizure activity in patients with epilepsy
over a period of time.
“We are continuing to support new technologies to detect,
monitor and treat epilepsy through the New Therapy Grants award program,” said
Warren Lammert, Chairman of the Epilepsy Therapy Project. “In this grant cycle,
we have selected four projects that may prove critical to managing and treating
epilepsy and to accelerating the development of future new therapies. With these
grants and the support and guidance our organizations can offer, we are
advancing important new products to market and so to people with epilepsy.”
For a comprehensive list of all epilepsy therapies in
development including past projects supported by the New Therapy Grants
program, please visit http://www.epilepsy.com/etp/pipeline_new_therapies.
The epilepsy pipeline identifies the most promising products from early-stage
development to commercial-stage, and whether a product is currently available
in the US or internationally.
“The mission of this collaborative grant program is to
improve the quality of life for people living with epilepsy in their
lifetimes,” said Sandy Finucane, Executive Vice President of the Epilepsy
Foundation. “Epilepsy affects nearly three million people in the United States
and 65 million people worldwide. Even with current treatments, close to one
third of people with epilepsy live with uncontrolled seizures and there remains
an overwhelming need for new treatment options.”
The Grant Recipients
High Definition Cathodal Transcranial Direct Current for Treatment of Focal
Status Epilepticus (Soterix Medical Inc., New York, NY):
-
Phase 1 testing of a novel application of high-definition transcranial direct
current stimulation (HD-tDCS) – technology with demonstrated ability to limit
cortical excitability and suppress ongoing seizures in preclinical testing as a
new approach to treat intractable and/or ongoing focal seizures - Awarded to Alexander Rotenberg, M.D., Ph.D., Assistant Professor
of Neurology, Children’s Hospital Boston
Dr. Rotenberg and his team are developing a novel,
non-invasive form of cathodal transcranial direct current (tDCS), a painless
and safe method for focal brain stimulation. Despite its favorable safety profile
and a proven capacity to modulate cortical excitability, conventional tDCS
technology has not successfully been applied to the treatment of focal status
epilepticus (FSE), in part due to the poor spatial targeting. The research team
proposes to overcome this limitation with High Definition (HD)-tDCS and
hypothesizes that HD-tDCS can safely reduce seizure burden in patients with
FSE. FSE is characterized by repetitive discrete seizures often lasting more
than an hour (at times as long as days or weeks). Unfortunately, drug
treatments are often ineffective.
HD-tDCS devices are lightweight, inexpensive and can be
applied in minutes with minimal training. The proposed HD-tDCS platform is the
only neuromodulation technology capable of highly focused DC stimulation of
identified cortical targets, an essential safety feature for populations such
as children with epilepsy. Favorable data from the proposed studies may enable
larger trials of cathodal HD-tDCS in emergency seizure settings. Of note,
clinical applications for additional use of this technology in the management
of mood disorder and chronic pain are also in progress.
Direct Network Visualization of Drug Efficacy Using of MRI
(Stanford University, CA)
-
Preclinical evaluation of optogenic functional MRI (ofMRI) – an innovative
technology to assess the potential of new epilepsy therapies and their effect
on seizures through visualization of brain networks - Awarded to Jin Hyung Lee, Ph.D., Assistant Professor,
Neurology and Neurological Sciences, Bioengineering, Stanford University
Dr. Lee and her research team have utilized a revolutionary
technology, optogenic functional MRI (ofMRI), to directly visualize–in vivo–the
actual spread of seizure activity through brain networks as well as drug
effects on this seizure activity. The approach is to create an optogenic
seizure rat model by implanting a fiber-optic light source that can create
seizures on demand. The ofMRI imaging techniques would then display the
specific brain networks activated by the seizures, enabling precise knowledge
about which areas of the brain are affected. The technology may be used to
expedite preliminary evaluation of drugs and their potential value in
neurological disease. More specifically, with the potential to better visualize
brain region involvement and response, ofMRI may expedite drug screening and
reduce clinical trial costs by allowing better drug selection. The funding will
be applied to testing several drugs in two proprietary animal models with the
objective of accelerating the development of new neuroactive drugs and
treatments for epilepsy.
Validation of the ANI-SI Dry EEG Headset in Time-Critical
Applications (Advanced Neurometrics, Inc., San Diego, CA)
-
Clinical testing and validation of Advanced Neurometrics’ electroencephalogram
system (ANI-SI EEG) – a non-invasive dry electrode headset that rapidly records
EEG data with a minimum of patient preparation which would offer particular
value in the ER and intensive care settings where rapid diagnoses and prompt
treatment can result in faster seizure control. - Awarded to Wendy Catharina Ziai, M.D., M.P.H., Assistant
Professor, Neurology, Anesthesiology and Critical Care Medicine, Johns Hopkins
University School of Medicine
Dr. Ziai and her team with participating institution
University of California, San Francisco, will test Advanced Neurometrics’
ANI-SI EEG system in ER and intensive care units to evaluate how the device
performs in the measurement and characterization of seizures and other causes
of altered mental states compared to standard EEG. The ANI-SI EEG system is a
dry electrode headset that records EEG without requiring extensive and
time-consuming patient skin preparation, head measurements or gels. Timely
identification of the presence or absence of ongoing electrographic seizures is
critical for appropriate clinical care; delays in diagnosis may result in a
worse neurologic outcome. Most emergency rooms and hospitals lack the
capability for emergency EEG, which may be the only way to confirm if a patient
is experiencing a seizure or if decreased alertness is due to another
condition. The ANI-SI EEG system has thus far proven to record EEG signals with
high fidelity and has demonstrated significant promise in reducing time to
interpretable EEG data compared to wet electrode conventional EEG.
Wireless EEG Seizure Patch (Epitel, Inc., Salt Lake City,
Utah)
-
Phase 1 testing of Epitel, Inc.’s novel EEG device – a dermal patch device that
can wirelessly transmit EEG activity for approximately 12 days as a means of
augmenting seizure reporting and measurement - Designed to transmit when seizures are occurring, the device
provides high-quality data and long-term seizure monitoring that will drive
patient care, such as the selection of specific antiepileptic (AED) therapies
and regimens - Awarded to Mark Lehmkuhle, Ph.D., Chief Executive Officer,
Chief Technology Officer, Epitel, Inc.
Dr. Lehmkuhle and his team are conducting an expanded Phase
1 clinical study of a novel EEG device with potential to track the frequency of
drug-refractory epileptic seizures. Designed as an affordable wireless patch,
the device is small enough to be placed on the scalp for the identification of
abnormal brain activity in neonates, children and adults without requiring the
use of protective head gear or electrode wires. The low-power transmitter
signal is received by a USB sensor attached to a conventional smart phone,
which is used to verify signal quality. The device can log EEG activity for approximately12
days permitting users to proceed with their daily routines. In contrast to
current ambulatory EEG technology, this patch technology is small and discrete,
easy to conceal, and eliminates the social stigma associated with ambulatory
and outpatient monitoring.
The Epitel wireless EEG transmitter with data logger is the
first device designed to yield long-term data on seizure frequency for patients
whose seizures involve both hemispheres, such as patients with complex partial
seizures. The grant will support feasibility studies for tracking seizures in
patients with refractory epilepsy based on this relatively low-cost,
unobtrusive and patient-sensitive advanced technology. With improved and high-quality
access to quantitative data of seizure frequency and pattern and seizure
history, the Epitel wireless device has the promise of better treatment
outcomes and may serve as a valuable screening tool for clinical trials.
About The New Therapy Grants Program
The New Therapy Grants Program is a unique joint venture between two non-profit
epilepsy organizations, The Epilepsy Therapy Project and the Epilepsy
Foundation. Grants are awarded to support programs that demonstrate promise as
new treatments through critical early clinical milestones and readiness for
further investment and development. Applications are evaluated by professional
scientific and business advisory board members. Awards are given based on the
potential to provide substantial benefit in a timeframe relevant to those
living with epilepsy today. To date, close to 60 grants have been awarded for
the advancement of new therapeutics and devices that have demonstrated a more
rapid path to benefitting patients and future commercialization.
Upcoming Grant Applicants: Note Deadline for Letter of
Intent is August 9, 2013
The New Therapy Grants Program is requesting proposals from scientific and
clinical investigators pursuing innovative projects that demonstrate a clear
path to commercialization. The program accepts the submission of proposals
ranging from $50,000 to $500,000. The deadline to submit a Letter of Intent
(LOI) is August 9, 2013. If LOI is selected for full proposal, submissions are
due September 25, 2013. To apply or view additional requirements, visit http://www.epilepsy.com/etp/support_translational.
About Epilepsy
When a person has two or more unprovoked seizures, they have epilepsy. Epilepsy
conditions affect nearly three million people in the United States and 65
million people worldwide. This year, another 200,000 people in the U.S. will be
diagnosed with epilepsy. Despite all available treatments, 30 to 40 percent of
people with epilepsy continue to experience seizures.
About the Epilepsy Foundation
The Epilepsy Foundation, a national nonprofit with affiliated organizations
throughout the United States, has led the fight against epilepsy since 1968.
The Foundation’s mission is to stop seizures, find cures and overcome the
challenges created by epilepsy. For additional information, please visit www.epilepsyfoundation.org.
About the Epilepsy Therapy Project
The Epilepsy Therapy Project is a 501(c) (3) non-profit organization whose
mission is to accelerate ideas into therapies for people living with epilepsy
and seizures. Founded in 2002 by a group of parents, distinguished physicians,
and researchers, the Epilepsy Therapy Project supports the commercialization of
new therapies through direct grants and investments in promising academic and
commercial projects. For more information about epilepsy, epilepsy treatment
and the epilepsy pipeline, or to donate, please visit our website, www.epilepsy.com or call 540.687.8077.