Pioneering new treatment category - site-specific delivery of drugs to the brain
MIDDLEBURG, Va., and DENVER, April 28, 2011 /PRNewswire-USNewswire/ -- Epilepsy Therapy Project (ETP), a non-profit organization whose mission is to accelerate new therapies for people living with epilepsy and seizures, and ICVrx, LLC (ICVrx), a pharmacy product research and development company focused on novel therapies for central nervous system (CNS) disorders, announced today that ETP has made an investment in ICVrx to support the development of ICVrx's targeted epilepsy drug technology for patients whose seizures are not controlled by current therapies.
"Our business and scientific advisory boards are enthusiastic about ICVrx's strategy of combining a drug delivery pump technology with established epilepsy medications for direct administration to the central nervous system," said Warren Lammert, Chairman and Co-founder of the Epilepsy Therapy Project and www.epilepsy.com. "This approach may reduce systemic toxic effects of selected oral anti-epilepsy drugs, facilitate increased local drug concentrations at the site of action, and offer the potential to improve overall tolerability of the effective dose. ETP is making a special-case investment in ICVrx's promising technology for the millions of people suffering uncontrolled, or refractory, epilepsy."
"We are honored to receive ETP's investment, which enables ICVrx to move forward with Phase 1/2 proof-of-concept clinical studies, an important milestone in our effort to bring this new class of therapy to patients. ETP's business and medical leadership are among the best in CNS drug and device development. We deeply appreciate their interest in and support of our work," said Daniel J. Abrams, M.D., Chief Executive Officer of ICVrx.
The Epilepsy Therapy Project is committed to investing in promising start-up companies with an emphasis on facilitating the development of treatments for epilepsy. These investments are unique in that they focus on projects demonstrating a clear path from research in the laboratory to the commercialization of new treatments for epilepsy.
ICVrx has completed preclinical work and will now start clinical studies of three generic drugs reformulated for implanted pump delivery to brain sites. The aim is to provide the medically refractory epilepsy community a "first choice" treatment option, as current options, which include removal of a brain lobe, are high-risk, high-cost, and irreversible.
Surgery to insert the implant able pump and catheter used to implant ICVrx's pharmaceuticals takes approximately 45 minutes and is similar to surgery for implanting a pump for spinal drug delivery, which has been performed successfully in over 100,000 patients. Implantable pumps have the potential to deliver as many drugs as are effective and safe for people suffering from brain diseases.
About Epilepsy and "Medically Refractory" Epilepsy
When a person has two or more unprovoked seizures, they have epilepsy, which affects nearly three million people in the United States and 50 million people worldwide. Disease incidence is approximately one percent-the same as diabetes. This year, another approximately 200,000 people in the United States will be diagnosed with epilepsy. There are more people with epilepsy than with multiple sclerosis, Parkinson's disease, and primary brain tumor sufferers combined. To date, while there have been certain advances, there is no known cure for epilepsy and many people live with uncontrolled daily seizures.
Medically refractory epilepsy is generally defined as: inadequate seizure control despite appropriate medical therapy with at least two anti-epileptic oral drugs, or as: adequate seizure control with unacceptable drug-related side effects. "Inadequate seizure control" is generally characterized as one or more seizures per month. Medically refractory epilepsy includes up to 32% of patients with epilepsy (Kwan and Brodie NEJM 2000).
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.
About ICVrx
ICVrx, LLC, is a pharmacy product research and development company focused on novel therapies for central nervous system disorders. Its leadership team combines industry and medical experts in neurology, neurosurgery, pharmacy, and drug and device commercialization. For its first disease, epilepsy, ICVrx is pioneering a new treatment category-site-specific delivery of drugs within the brain-to help patients resistant to oral drugs. ICVrx licensed its site-specific drug delivery technology from the University of Colorado. For more information about ICVrx, please call Jim Hock 760.564.7400, our Investor Relations Representative, or Vincent Dipas 303.591.7919, our Media Relations Representative.