Epilepsy Therapy Project, EF announce recipients of New Therapy Grants Program

New Therapy Grants Program Announces Call for New Therapeutic and Medical Device Grant Applications for Upcoming Fall Awards

The Epilepsy Therapy Project (ETP) and the Epilepsy Foundation (EF) today announced the latest grant recipients of its New Therapy Grants Program, a unique joint venture of the non-profit epilepsy organizations, to advance promising epilepsy research in clinical development.  The grant awards, totaling approximately $200,000 in funding, will support an experimental gene therapy that directly targets epileptogenic brain tissue, as well as an electrode system that has the potential to improve the efficacy of surgical therapies for certain epilepsy syndromes.  

"Patients need new options to treat and manage epilepsy, and through this grant program we are excited to see such remarkable innovation in the field.  The fields of gene therapy and surgical treatment of epilepsy remain cutting-edge with much to be explored in terms of advancing epilepsy treatment outcomes," said Orrin Devinsky, MD, ETP Co-Founder and Vice President for Translational Programs, Professor of Neurology, Neurosurgery, and Psychiatry, and Director, NYU Comprehensive Epilepsy Center, New York University.  "By choosing to support these two promising programs, we hope to see important strides made while encouraging researchers and companies to pursue new ideas and approaches in epilepsy and seizure conditions."

The New Therapy Grants program grants are designated to facilitate the advancement of new treatments through critical early-stage clinical development or to bridge the gap from preclinical to clinical development to ensure patients will have the opportunity to benefit from groundbreaking progress in the field of epilepsy.  The award committee, which is comprised of clinical, scientific and industry representatives, evaluates applications to support new therapeutic approaches submitted by highly qualified clinical experts and scientists with the greatest potential for near-term patient benefit.

"The need and market opportunity for new therapies in epilepsy is unmistakable," said Warren Lammert, Chairman of the Epilepsy Therapy Project.  "One third of the people with epilepsy live with uncontrolled seizures despite all available therapies and perhaps another one third achieve seizure control but at the price of unacceptable side-effects including fatigue and impact to cognition.  Yet moving promising ideas out of research labs and on through the process of clinical and commercial development is an enormously expensive process with miniscule odds of success for each individual project.  Further, epilepsy therapy development has been neglected by government and private funding sources, and current economic uncertainties have further diminished the availability of risk capital.  In this environment, the importance of our New Therapy Grants in moving the most promising new research ideas across the starting line on to a path of clinical development cannot be overstated.  My hope is that we can mobilize increased support and expand this vital program so necessary to improving the lives of people living with epilepsy."

"These research projects represent the essence of translational research and the focus of our New Therapy Grants Program," said Joyce Bender, chair of the Epilepsy Foundation board of directors.  "We proudly applaud our grant recipients because their studies may provide new treatment options, which could lead to an improved quality of life for the nearly 3 million people in the United States and 50 million people worldwide living with epilepsy."

The Grant Recipients

Galanin Gene Delivery to the Hippocampus for Mesial Temporal Lobe Epilepsy

• Prospect of one-time gene therapy that produces anti-convulsant and neuroprotective benefits
• Experimental therapy may offer less invasive therapeutic option and a prospective paradigm shift in patient care for certain forms of epilepsy

Scott McPhee, Ph.D., Vice President of Clinical Development, Asklepios BioPharmaceutical Inc., and Nicholas Boulis, M.D., Assistant Professor, Neurosurgery, Emory University, will be conducting preclinical studies of a Galanin gene delivery for selected patients with uncontrolled Mesial Temporal Lobe Epilepsy (MTLE). Direct delivery of a gene therapy to the temporal lobe offers the significant potential of a less invasive, more effective alternative approach that precludes the trauma and resulting complications of surgical tissue removal, and avoids the side effects of standard pharmacological treatments. The protein galanin has been shown to suppress seizures. Gene delivery of galanin DNA has been shown to have anticonvulsant and neuroprotective effects in models of MTLE. Unlike traditional anti-epileptic medications, galanin gene delivery may be administered in a one-time intervention that provides long-term supplemental galanin in the epileptogenic tissue. The proposed therapeutic approach represents a paradigm shift in the treatment of epilepsy because gene delivery offers to locally regulate activity rather than destroying tissue.   In addition, it has the unique and significant potential to one day provide a strategy for the treatment of critical brain tissue in which tissue removal is not currently a therapeutic option.  These experiments may not only provide a unique opportunity for the development of novel epilepsy therapies but may also advance the cause of neurological gene therapy in general.

The preclinical research outlined by the grant recipients is expected to support the filing of an Investigational New Drug (IND) Application for a Phase I clinical trial.  Funding of the preclinical protocol is subject to appropriate institutional review and approvals, as well as securing the additional financial support needed to complete the research.

Intracranial EEG Acquisition System with Online Fast Ripple Detection

• New technology to refine how surgeons will identify and define epileptogenic regions of the brain
• Potential to improve surgical outcomes and broaden viability of treatment for certain epilepsy syndromes  

A Columbia University Medical Center research team headed by Catherine Schevon, M.D., Assistant Professor, Neurology, received funding to support the refinement of an intracranial EEG recording system, an online detection system to better define the epileptogenic region of the brain, the area of the brain related to seizure activity, before therapy or surgery.

Surgical excision of the epileptogenic brain region is an important treatment modality for medically refractory partial epilepsy, with greater than 60 percent or more of patients achieving seizure freedom.  The success rate is notably worse, however, when a structural lesion cannot be identified, and may be as low as 35 percent in patients with extratemporal non-lesional syndromes.  In these cases, the resection choice depends almost entirely on accurate interpretation of the intracranial EEG (iEEG), obtained by recording from electrodes implanted directly onto the brain surface or into the parenchyma.  Recognizing these limitations surgical therapy for extratemporal epilepsy syndromes is not currently recommended for widespread clinical use.

High frequency oscillations (HFO) in the brain can identify areas for epilepsy surgery treatments, but are technically difficult to detect, largely limiting their clinical utility.  Grant funding will be applied to the development of this new system to bring automatic online HFO detection into clinical practice, making current surgical treatments more effective, and potentially simplifying surgeries for many epilepsy syndromes.  By increasing the specificity of the identification of the epileptogenic region, seizure outcomes can be improved while the area of brain that must be removed is minimized.

Upcoming Grant Applicants:  Note Deadline for Letter of Intent is September 3, 2010

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 3, 2010.  Applicants who have an accepted LOI have until October 15, 2010, to submit their full proposals.   To view additional requirements, please visit http://www.epilepsy.com/etp/support_translational.  

The New Therapy Grants Program is a unique partnership between two leading epilepsy non-profit organizations, the Epilepsy Therapy Project and the Epilepsy Foundation.  The mission of the New Therapy Grants Program is to drive the development of new therapies for epilepsy, accelerating the advancement of research from the laboratory to the patient.  Funding is provided for grants supporting the research and development of new therapies in both academic and commercial settings worldwide.