Grant: HE3286 treatment of drug resistant epilepsy
Harbor Therapeutics, Inc.
San Diego, CA
Clarence Ahlem, M.S., Vice President, Harbor Therapeutics, Inc. and his team received a grant supporting the preclinical development of Harbor Therapeutic's anti-inflammatory drug HE3286 in drug resistant epilepsy. HE3286 is currently in Phase II clinical trials for diabetes.
Brain inflammation is linked to epilepsy including drug resistant seizures, and specific anti-inflammatory drugs have been able to suppress ongoing seizures in animal models of chronic epilepsy. HE3286 is an orally bioavailable, blood-brain-barrier permeable anti-inflammatory compound that is being repurposed for epilepsy. The anti-inflammatory action of HE3286 demonstrated in several different inflammatory disease models—including Parkinson's disease and multiple sclerosis—provides a strong rationale for its evaluation in epilepsy.
The specific study to be performed will be a preclinical study in chronic seizures in mice—specifically in a model that captures the complex chronic inflammatory interactions which have been shown to be targeted by the mechanism of action of this compound in other disease models. The study will be performed by Annamaria Vezzani, PhD, Head of the Laboratory of Experimental Neurology at the world-renowned Mario Negri Institute for Pharmacological Research, Milan, Italy. Dr. Vezzani maintains one of the few laboratories in the world with significant experience in the mouse model of chronic epilepsy. The proposed experiments in mice will be completed within one year of the grant award.
June 2012: New Therapy Grant Awards
Grant: High Definition Cathodal Transcranial Direct Current for Treatment of Focal Status Epilepticus
Soterix Medical Inc.
New York, NY
Alexander Rotenberg, M.D., Ph.D., Assistant Professor of Neurology,
Children's Hospital Boston 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 b y 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.
Grant: Direct Network Visualization of Drug Efficacy Using ofMRI
Jin Hyung Lee, Ph.D., Assistant Professor, Neurology and Neurological
Sciences, Bioengineering, Stanford University 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.
Grant: Validation of the ANI-SI Dry EEG Headset in Time-Critical Applications
Advanced Neurometrics, Inc.
San Diego, CA
Wendy Catharina Ziai, M.D., M.P.H., Assistant Professor, Neurology,
Anesthesiology and Critical Care Medicine, Johns Hopkins University
School of Medicine 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
Grant: Wireless EEG Seizure Patch
Salt Lake City, UT
Mark Lehmkuhle, Ph.D., Chief Executive Officer, Chief Technology
Officer, Epitel, Inc. 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 approximately
12 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 he mispheres, 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.