Enrollment Commences in NeuroSigma-Sponsored Pediatric Clinical Trial for the Treatment of Lennox-Gastaut Syndrome

LOS ANGELES, July 22, 2014 /PRNewswire/ -- NeuroSigma, Inc. (NeuroSigma), a California-based life sciences company focused on commercialization of its non-invasive Monarch™ eTNS™ Therapy for the treatment of neurological and neuropsychiatric disorders, today announced that enrollment has begun in a pediatric open label study of external trigeminal nerve stimulation (eTNS) as adjunctive therapy for the treatment of Lennox-Gastaut Syndrome (LGS).

The trial is being conducted at the Olive View-UCLA Medical Center in Sylmar, California, and led by Professor D. Alan Shewmon, M.D., Chief of Neurology at Olive View and Vice Chair of Neurology at the David Geffen School of Medicine at the University of California, Los Angeles (UCLA).  The U.S. National Institutes of Health (NIH) has provided grant funding to NeuroSigma to support this open label trial of eTNS in children with LGS, ages 8 to 18.  The children in this study will use the eTNS therapy each night at home while remaining on their antiepileptic medications.  An earlier Phase II clinical trial of eTNS therapy for the treatment of drug-resistant epilepsy (DRE) in adults found significant improvements in the frequency of seizures with 18 weeks of nightly eTNS therapy. Dr. Shewmon does not have an affiliation with NeuroSigma.

LGS is a catastrophic form of childhood epilepsy characterized by three key features: multiple types of seizures, particularly "tonic" (stiffening) and "atonic" (drop) seizures; impaired intellectual development; and specific abnormalities on the electroencephalogram (brain wave test). Seizures usually develop between 3 and 5 years of age.  LGS is often difficult to control with ordinary antiepileptic drug treatments.  The Epilepsy Foundation reports that LGS accounts for 2-5% of childhood epilepsies.

"LGS is a severely disabling condition. Some of these children have very frequent seizures – up to several a day – despite high doses of multiple antiepileptic medications. eTNS is a promising new approach to the treatment of drug-resistant epilepsy in general, and we are eager to find out whether it could be helpful in this very challenging subset of patients," said Dr. Shewmon.

"Children with LGS are often severely drug resistant, and continue to have frequent seizures despite trying multiple antiepileptic medications, often in combination.  These children can be injured when they fall during drop attacks, a problem that frequently persists into adulthood. Helping children and their families deal with the symptoms and the severe disability of LGS represents a significant unmet clinical need," added Christopher DeGiorgio, M.D., NeuroSigma's Vice President of Neurology and the Professor of Neurology at UCLA who first investigated eTNS for DRE.  "Recent data from European clinical use of our eTNS therapy suggests that it is safe to use in children, and we're eager to learn what benefits can be detected with eTNS therapy in children with LGS." 

"We are delighted that Dr. Shewmon and his collaborators at Olive View have begun enrolling children into this trial.  Besides possibly affording better control of seizures, our adjunctive treatment may lessen the need for antiepileptic drugs and thus allow children to avoid the medication side effects that can interfere with schoolwork and social development," noted Leon Ekchian, Ph.D., NeuroSigma's President and CEO.

Background – The Monarch eTNS System from NeuroSigma

In August 2012, NeuroSigma received CE Mark approval to market NeuroSigma's first trigeminal nerve stimulation (TNS) product, the Monarch™ eTNS™ System, in the European Union, for the adjunctive treatment of epilepsy and major depressive disorder (MDD) for adults and children nine years and older. In addition, the Monarch™ eTNS™ System also received a Class II medical device license from Health Canada in April of 2013, allowing NeuroSigma to market the system for treatment of drug-resistant epilepsy (DRE) and MDD for adults and children nine years and older.  In April of 2014, NeuroSigma received approval from the Australian Therapeutic Goods Administration (TGA) to market the system in Australia for the adjunctive treatment of DRE in adults and children nine years and older. NeuroSigma is currently offering the Monarch™ eTNS™ System to patients in these jurisdictions, with a physician's prescription.

The Monarch™ eTNS™ System is composed of a cell-phone sized pulse generator and a single-use patch that is applied to the forehead.  Signals are transmitted through lead wires to the patch in order to stimulate the trigeminal nerve in the skin of the forehead; triggering these nerve fibers sends signals to targeted brain regions and changes the activity there.  Patients may conveniently self-administer the Monarch™ eTNS™ System at home and typically use the device while sleeping.

Background – TNS

The trigeminal nerve is the largest cranial nerve, offering a high-bandwidth pathway for signals to enter the brain, bilaterally and at high frequency. The trigeminal nerve projects directly or indirectly to specific areas of the brain, such as the locus coeruleus, nucleus tractus solitarius, thalamus, and the cerebral cortex, which are involved in epilepsy, depression, PTSD, ADHD, and other disorders. 

Trigeminal Nerve Stimulation (TNS) is the electrical stimulation of branches of the trigeminal nerve, which are located near the surface of the forehead.  Functional neuroimaging data suggests the mechanism of action of TNS is related to its ability to modulate activity in targeted brain regions.

CAUTION: In the United States, eTNS™ is an investigational device and is limited by Federal law to investigational use.  The U.S. Food and Drug Administration (FDA) has given NeuroSigma approval to proceed with a pivotal Phase III clinical trial of eTNS in drug-resistant epilepsy. Completion of that Phase III study is necessary before the FDA will consider permitting the marketing and sale of eTNS in the United States.

eTNS, Monarch, and Monarch eTNS are trademarks of NeuroSigma, Inc.

Research reported in this press release is supported by the National Institute of Neurological Disorders and Stroke of the National Institutes of Health, under Award Number R41-NS076014.  The content is solely the responsibility of NeuroSigma and does not represent the official views of the National Institutes of Health.

About NeuroSigma, Inc.

NeuroSigma is a Los Angeles-based life sciences company established to develop bioelectronic technologies with the potential to transform medical practice and patients' lives.  NeuroSigma is focused on TNS neuromodulation therapies based on intellectual property licensed on an exclusive basis from the University of California, Los Angeles (UCLA), including TNS therapies for epilepsy, depression, post-traumatic stress disorder (PTSD) and attention-deficit hyperactivity disorder (ADHD). For more information about NeuroSigma, please visit http://www.neurosigma.com.

Forward-Looking Safe Harbor Statement

This press release contains forward-looking statements, including but not limited to, research and development outcomes, efficacy, adverse reactions, market and product potential, product availability and other statements regarding our eTNS™ system.  These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from the Company's expectations and projections. Risks and uncertainties include, among other things, general industry and medical device market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to new product marketing, such as the unpredictability of market acceptance for new medical device products; inconsistency of treatment results among patients; potential difficulties in manufacturing a new product; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations.

SOURCE NeuroSigma



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