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SOURCE NeuroSigma, Inc.
European Clinical Data and Mechanism of Action Results Presented
LOS ANGELES, July 8, 2014 /PRNewswire/ -- NeuroSigma, Inc. (NeuroSigma), a California-based life sciences company focused on commercialization of its non-invasive Monarch™ eTNS™ System for the treatment of neurological and neuropsychiatric disorders, today announced top-line summaries of presentations made last week at the 11th European Congress on Epileptology in Stockholm, Sweden, related to the use of external trigeminal nerve stimulation (eTNS) in epilepsy.
Sean Slaght, M.D., Ph.D., reported an update of observational findings in on-going adjunctive treatment with eTNS of adults at Kings College London (KCL), UK. In a group of 13 real-world, care-seeking patients with drug resistant epilepsy (DRE), who completed at least 12 weeks of nightly use of the Monarch, they observed a median reduction in seizure frequency of 38%. The KCL researchers additionally reported on significant improvement in quality of life, mood, and sleep metrics.
In the first-ever use of eTNS in pediatric patients with DRE, Dr. Slaght reported preliminary findings on seven children, age 10 to 17, treated with this non-invasive, adjunctive therapy. Three children (43% of the group) reported a 50% or more reduction of their seizure frequency after 18 weeks.
Observational findings were also presented by José Serratosa, M.D., Ph.D., from the Fundación Jiménez Díaz University Hospital, Madrid, Spain. In a group of eight adult patients treated with eTNS, 25% experienced a decrease in seizures of over 90%.
Consistent with earlier Phase I and II trials conducted in the United States, the European groups reported an absence of serious adverse events.
Other investigators from KCL reported data on measures of cortical excitability in five adult DRE patients undergoing eTNS treatment for 18 weeks. Brief magnetic pulses were used to assess cortical function before and after a course of treatment, in an effort to evaluate the mechanism of action of eTNS. Adam Pawley presented work conducted with Professor Mark Richardson at KCL. Measures of cortical excitability consistently decreased with use of eTNS, implicating potential effects on signaling in both GABAA- and GABAB-mediated circuits. Other antiepileptic therapies have previously been shown to reduce measures of cortical excitability.
Christianne Heck, M.D., M.M.M., from the University of Southern California (USC), Los Angeles, chaired a satellite symposium, "Trigeminal Nerve Stimulation (TNS): Neuromodulation for the 21st Century." This session introduced TNS to a large number of epileptologists attending the Congress and provided them with both background neurobiological data and clinical results.
"The experience at these leading European epilepsy centers bears out the safety profile we have seen in the U.S. for eTNS, and provides confirmatory evidence of the effects of eTNS on seizures, mood, sleep, and quality of life," said Christopher DeGiorgio, M.D., NeuroSigma's Vice President of Neurology and the Professor of Neurology who first investigated eTNS for DRE at the University of California, Los Angeles (UCLA). "Millions of people living with epilepsy are still having seizures despite the best medication treatment available, often facing cognitive side effects from multiple antiepileptic drugs and the disease itself. eTNS may become an important tool to address this unmet medical need."
"While these studies were of modest size, the researchers conducting these independent effectiveness evaluations are in the vanguard in providing important data that complement the findings from controlled clinical trials. These findings provide us with confidence in the design of the pivotal trial in DRE that we are preparing to commence. Further, the work with cortical excitability elucidates another biological mechanism by which eTNS may achieve its anticonvulsant effect, and builds on the data showing acute changes in regional brain activity observed with PET scanning at UCLA," added Ian Cook, M.D., Chief Medical Officer and Senior Vice President at NeuroSigma.
NeuroSigma provided eTNS Systems to the investigators' institutions, but was otherwise uninvolved in the conduct of the research at either KCL or the Fundación Jiménez Díaz University Hospital.
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 drug-resistant epilepsy (DRE) 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 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 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 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 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.
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 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.
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