Epilepsy Research Foundation Awards Funds to Three Promising New Epilepsy Therapies.

Four Foundations Join to Support Chinese Herb Compound; a Biodegradable Drug-Releasing Brain Implant; and a New Refractory Epilepsy Agent

RESTON, Va. & SAN DIEGO -- The Epilepsy Research Foundation, a collaboration of several non-profit organizations, including the Epilepsy Foundation, the Epilepsy Therapy Development Project and Finding a Cure for Epilepsy and Seizures (FACES), together with the Milken Family Foundation, a private philanthropic foundation, today announced recipients of translational research funds totaling over $400,000 to advance three promising new epilepsy therapies. These awards, which support the advancement of new therapies through translational research and potentially early clinical development, are being presented to physicians and scientists developing promising treatments with high-impact, near-term patient benefits. The funded projects include a Phase IIa clinical trial of a compound derived from a Chinese herb - the first modern era clinical study of an herbal-derived compound for epilepsy, research of a galanin-based therapy for a much-needed new treatment of refractory epilepsy, and the development of biodegradable adenosine-releasing brain implants for the treatment of temporal lobe epilepsy. The announcements were made during the annual meeting of the American Epilepsy Society, the professional organization of epilepsy care providers and scientists convened in San Diego, CA.

"About one third of people with epilepsy or one million men, women and children in the United States face persistent seizures despite all currently available therapies. Many others must accept significant side effects as the price for seizure control," said Warren Lammert, a Cofounder and Chairman of the Epilepsy Therapy Development Project. "The opportunity to support projects such as the development of biodegradable brain implants delivering a known anticonvulsant as well as a human trial to validate the pre-clinical findings of a Chinese herbal medicine is very promising as these treatment approaches could answer the critical need for greater seizure control and success in patients with epilepsy."

"We, as a conjoined group, focused on addressing epilepsy in all its forms, are once again excited to support such exceptional potential in breakthrough epilepsy research," said Eric R. Hargis, Epilepsy Foundation President and CEO. "Each of today's awards will support exciting translational research deemed to have high potential in providing therapeutic efficacy across a broad spectrum of underserved patients with genetic and acquired forms of epilepsy, including some of the most severe forms of this common neurological disorder."

Recipients of the Fall 2006 Epilepsy Research Foundation Funds

A New Approach for Refractory Epilepsy

Detlev Boison, Ph.D., Associate Scientist, Director Epilepsy Program, R.S. Dow Neurobiology Laboratories, Legacy Research, Portland, Oregon and David L. Kaplan, Ph.D., Chair, Department of Biomedical Engineering, Director, Bioengineering & Biotechnology Center, Tufts University, Medford, Massachusetts are the recipients of a grant to pursue the development of adenosine-releasing brain implants for the treatment of temporal lobe epilepsy. Adenosine, an endogenous neuromodulator, has potent anticonvulsive properties and requires long-term delivery directly to the brain. This study aims to develop intraventricular implants of biodegradable silk protein polymers in combination with adenosine for therapeutic delivery of adenosine in a rat model. Both the silk polymer and adenosine are approved by the U.S. Food and Drug Administration for clinical use, and this study aims to engineer a safe delivery system for adenosine that can be employed in clinical feasibility and safety trials.

Clinical Validation of a Valued Chinese Herb in Epilepsy Treatment

Steven Schachter, M.D., Professor of Neurology, Harvard Medical School, Associate Director of Clinical Research, HMS Osher Institute, Director of Research, Department of Neurology, Beth Israel Deaconess Medical Center, will pursue a Phase IIA dose-escalation study for the treatment of epilepsy with Huperzine A. This compound, derived from a Chinese herb, is available in the U.S. as a dietary supplement and approved for the treatment of Alzheimer's disease in China, having been administered to over 1,400 healthy volunteers and patients in numerous trials, demonstrating safety and tolerability. Dr. Schachter and colleagues discovered the anticonvulsant properties of Huperzine A in preclinical studies. This study will evaluate this compound as an add-on therapy in patients with refractory epilepsy for its safety and tolerability as well as provide a preliminary assessment of its effectiveness for seizures and its actions on mood and memory.

Anti-epilepsy Agents Modified to Cross the Blood Brain Barrier

Grzegorz Bulaj, Ph.D., Department of Medicinal Chemistry, College of Pharmacy, University of Utah, received a grant to pursue research in the development of a galanin-based therapy for the treatment of refractory epilepsy. Galanin, a neuropeptide, possesses both anticonvulsant and antiepileptogenic activity when injected directly into the brain. This study aims to chemically synthesize four galanin analogs modified to facilitate transport through the blood brain barrier to overcome this obstacle. These analogs will be evaluated for their biological stability, bioavailability, potential toxicity and anticonvulsant efficacy and potency following intraperitoneal and oral administration. This study is part of a larger preclinical investigation anticipated to result in the selection of one or two Investigational New Drug candidates for advanced preclinical testing.

About the Epilepsy Research Foundation

The Epilepsy Research Foundation was created to support the development of new, innovative translational research in producing new therapies and a cure for epilepsy. The organization was formed by the Epilepsy Therapy Development Project and the Epilepsy Foundation and includes support from Finding A Cure for Epilepsy and Seizures (FACES). All money raised goes directly toward highly promising research projects that can be fast tracked in the fight against seizures. For further information, or to contribute, please visit www.epilepsytdp.org, www.epilepsyfoundation.org, or contact the Epilepsy Research Foundation at 800-470-1655.

About the Epilepsy Foundation

The Epilepsy Foundation, a national non-profit with affiliated organizations throughout the United States, has led the fight against epilepsy since 1968. The Foundation's goals are to ensure that people with seizures are able to participate in all life experiences; and to prevent, control and cure epilepsy through research, education, advocacy and services. For additional information, please visit www.epilepsyfoundation.org.

About the Epilepsy Therapy Development Project

The Epilepsy Therapy Development Project is a non-profit organization whose mission is to advance new therapies for people living with epilepsy. Founded in 2002 by a group of parents, distinguished physicians and researchers, the Epilepsy Therapy Development Project supports the commercialization of new therapies through direct grants and investments in promising academic and commercial projects. The organization has raised over five million dollars towards its mission. For more information visit www.epilepsytdp.org.

About FACES

FACES is a non-profit organization affiliated with the NYU Comprehensive Epilepsy Center. Founded in 1996 by Orrin Devinsky, M.D., Director of the NYU Comprehensive Epilepsy Center, FACES' mission is to improve the quality of life for all people affected by epilepsy through research, education and awareness, and community-building events. For further information, please visit www.nyufaces.org.

About the Milken Family Foundation

The Milken Family Foundation was established by brothers Lowell and Michael Milken in 1982 with the mission to discover and advance inventive, effective ways of helping people help themselves and those around them lead productive and satisfying lives. The Foundation advances this mission primarily through its work in education and medical research. To learn more, visit www.mff.org.