The Epilepsy Therapy Project (ETP) and the Epilepsy Foundation (EF) announced today a New Therapy Grant to potentially help those with treatment resistant epilepsy. This grant was awarded to Alexander Rotenberg, M.D., Ph.D., Assistant Professor of Neurology, Children's Hospital Boston, and will support a clinical study to evaluate the repetitive transcranial magnetic stimulation (rTMS) H-Coil as a promising non-invasive method of inhibiting the abnormal electrical activity believed to underlie seizures in focal temporal lobe epilepsy (TLE). Seizures originating in this part of the brain are often difficult to treat and resistant to existing therapies.
"Temporal lobe epilepsy accounts for nearly 20 percent of all epilepsy and an estimated 70 percent of drug resistant focal epilepsy cases. rTMS is a new therapeutic intervention of immediate importance to patients with poor seizure control," said Dr. Rotenberg. "This award will speed the development of this approach to deep brain stimulation to treat temporal lobe epilepsy."
Dr. Rotenberg's program is based upon the premise that seizures may be managed by applying deep magnetic stimulation delivered around the head by the H-Coil technology to areas of the brain such as the temporal lobe, an area where many seizures start. The rTMS technology is approved for use in the treatment of major depression and other neuropsychiatric syndromes in Europe and Israel and marketed by Brainsway Ltd.
rTMS for Treatment of Temporal Lobe Epilepsy
Repetitive transcranial magnetic stimulation is a safe and painless method for focal brain stimulation, where small electrical currents inside the brain are induced by a powerful fluctuating magnetic field from outside the brain. Previous testing of low frequency rTMS did reduce brain excitability and suppressed seizures in some patients, but not in patients with TLE. However, the H-Coil's stronger effect penetrates into deeper brain regions.
Dr. Rotenberg and his research team hypothesize that rTMS with the H-Coil, designed to generate sufficient magnetic field strength, can safely and effectively stimulate deeper brain structures and may inhibit the electrical and neurotransmitter activity that underlies seizures in TLE. Their hypothesis is based in part on the encouraging antiepileptic effect of conventional rTMS in other types of epilepsy, and on their animal studies which showed that deeper brain stimulation by rTMS can suppress seizures in rats. The New Therapy Grant will support a clinical study of the H-Coil in children and adults with intractable TLE.
If this study shows the expected effect in seizure control, the H-Coil could rapidly move to commercialization for TLE treatment because a different version of the H-Coil that targets other deep brain areas is already marketed for treatment of major depression and other neuropsychiatric syndromes.
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 scientific and business advisory board members including experienced clinicians, scientists, investors and pharmaceutical and device industry executives. Awards are given based on the potential to provide substantial benefit in a time-frame relevant to those living with epilepsy today. To date, more than 45 grants have been awarded for the advancement of new therapeutics and devices that have demonstrated a more rapid path to benefiting patients and future commercialization.
"We regard the New Therapy Grants Program as an engine to accelerate the development of the most promising new epilepsy therapies, especially approaches with near-term promise to improve the lives of those with epilepsy," said Warren Lammert, chairman of the Epilepsy Therapy Project. "We believe the H-Coil, with proven safety and efficacy in other medical conditions, may have direct applicability to epilepsy. We are pleased to provide critical clinical support that may advance this device towards proof of concept and late-stage evaluation."
"This innovative cutting edge study underscores the missions of our two organizations," said Rich Denness, president & CEO of the Epilepsy Foundation. "This kind of translational research transforms scientific concepts into real treatments for real people and can help eliminate seizures and improve the quality of life for people living with epilepsy."
Upcoming Grant Applicants: Note Deadline for Letter of Intent is September 2, 2011
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 September 2, 2011, and applicants have until October 14, 2011 to submit full proposals. To apply or view additional requirements, visit www.epilepsy.com/etp/support_translational.
The mission of the New Therapy Grants Program is to drive the development of new therapies for epilepsy and accelerate the advancement of research to the patient. Funding is provided for grants supporting the research and development of new therapies in academic and commercial settings worldwide.
When a person has two or more unprovoked seizures, they have epilepsy, which affects nearly 3 million people in the United States and 50 million people worldwide. This year, another 200,000 people in our country will be diagnosed with epilepsy. Despite all available treatments, 30 to 40% of people with epilepsy continue to experience seizures.
About Brainsway Ltd. -Brainsway Ltd. is dedicated to the development and marketing of Deep TMS (Transcranial Magnetic Stimulation) systems, novel, noninvasive medical device for treatment of a wide range of neurological and psychopathological disorders. In principle, any brain-related disorder that is associated with pathological activity of specific brain areas may be treated by this method. Potential applications include depression, addiction, schizophrenia, obesity, eating disorders, Parkinson's disease, Alzheimer's disease, autism and post-traumatic stress disorder. The unique technology of Brainsway is based on patents filed by the National Institutes of Health (NIH), and by the company. Brainsway has an exclusive license from the NIH for the patent and technology. Brainsway has recently received marketing approvals in Europe for treatment of major depression, bipolar depression and negative symptoms of schizophrenia with one version of their deep TMS H-Coil, and for Parkinson's disease with another version of the H-Coil.
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, please visit our website, www.epilepsy.com or call 540.687.8077.