Epilepsy Organizations Award Grant to Harbor Therapeutics to Study Anti-Inflammatory Drug in Epilepsy

Recent Evidence Suggests Potential Role of Inflammation in Epilepsy

San Diego, CA, and Washington, DC, December 3, 2012 --The Epilepsy Therapy Project (ETP) and the Epilepsy Foundation (EF) today announced that Harbor Therapeutics, Inc. ((HRBR.OB), a San Diego-based biopharmaceutical company, is the latest grant recipient of their New Therapy Grants Program, a unique joint venture of the two non-profit epilepsy organizations to advance clinical development and commercialization of promising epilepsy therapies.  The grant will support the preclinical development of Harbor Therapeutic’ s anti-inflammatory drug HE3286 in drug-resistant epilepsy.  HE3286 is currently in Phase II clinical trials for diabetes. The award was announced by the Epilepsy Therapy Project and the Epilepsy Foundation during the American Epilepsy Society (AES) 66th Annual Meeting in San Diego, CA. 

Brain inflammation is linked to epilepsy including drug resistant seizures, and specific anti-inflammatory drugs have been able to suppress ongoing seizures in animal models of chronic epilepsy.¹ HE3286 is an orally bioavailable, blood-brain-barrier permeable anti-inflammatory compound that is being repurposed for epilepsy. The anti-inflammatory action of HE3286 demonstrated in several different inflammatory disease models—including Parkinson’s disease and multiple sclerosis—provides a strong rationale for its evaluation in epilepsy.

ETP’s  Scientific Advisory Board and Business Advisory Board, which evaluated all grant applications, were enthusiastic about the project, entitled HE3826 Treatment of Drug Resistant Epilepsy,  and awarded funding of more than $60,000 to Harbor Therapeutics for the proposal submitted by Clarence Ahlem, Vice President of Product Development (cahlem@harbortx.com, www.harbortx.com).  The specific study to be performed will be a preclinical study in chronic seizures in mice—specifically in a model that captures the complex chronic inflammatory interactions which have been shown to be targeted by the mechanism of action of this compound in other disease models.  The study will be performed by Annamaria Vezzani, PhD, Head of the Laboratory of Experimental Neurology at the world-renowned Mario Negri Institute for Pharmacological Research, Milan, Italy.  Dr. Vezzani maintains one of the few laboratories in the world with significant experience in this mouse model of chronic epilepsy.  The proposed experiments in mice will be completed within one year of the grant award. 

“Through the New Therapy Grants award program we seek to support important new products with the potential to provide significant benefit to people currently living with epilepsy,” said Roger J. Porter, MD, Chief Scientific Officer, Epilepsy Therapy Project. “Harbor Therapeutic’s project is particularly compelling because HE3286 is already in Phase II clinical trials for type 2 diabetes and it is well positioned for rapid entry into epilepsy clinical trials if found active in the proposed epilepsy proof of concept studies.”

Chronic safety and pharmaceutical acceptability studies for HE3826 are complete; the drug has an excellent safety profile and good pharmaceutical characteristics. 

1. Vezzani, A, French, J, Bartfai, T and Baram, TZ (2011) The role of inflammation in epilepsy. Nat Rev Neurol 7, 31-40.

About The New Therapy Grants Program
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 professional scientific and business advisory board members. Awards are given based on the potential to provide substantial benefit in a timeframe relevant to those living with epilepsy today. To date, close to 60 grants have been awarded for the advancement of new therapeutics and devices that have demonstrated a more rapid path to benefitting patients and future commercialization.

For a comprehensive list of all epilepsy therapies in development including past projects supported by the New Therapy Grants program, please visit http://www.epilepsy.com/etp/pipeline_new_therapies.  The epilepsy pipeline identifies the most promising products from early-stage development to commercial-stage, and whether a product is currently available in the US or internationally.

Upcoming Grant Applicants:  Note Deadline for Letter of Intent is March 1, 2013
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 March 1, 2013. If LOI is selected for full proposal, submissions are due April 17, 2013.  To apply or view additional requirements, visit http://www.epilepsy.com/etp/support_translational. 

About Epilepsy
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 the Epilepsy Therapy Project and the Epilepsy Foundation
The Epilepsy Therapy Project and the Epilepsy Foundation recently announced an intention to merge (http://my.epilepsy.com/newsfeeds/press_release/999447).  The new organization will have unparalleled reach and leadership through a nationwide supportive care network, broad-based public awareness, education and focus on accelerating the clinical development of innovative therapies for people with epilepsy.

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.

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, or to donate, please visit our website, www.epilepsy.com or call 540.687.8077.