Proximagen Group plc, the biotechnology company focused on diseases of the central nervous system, has signed a Collaboration Research and Development Agreement (CRADA) with the National Institute of Neurological Disorders and Stroke (NINDS) at the National Institutes of Health (NIH) in the United States.
Under the terms of the CRADA, NINDS will fully fund and carry out a double-blind, cross-over, placebocontrolled, phase-II clinical trial in patients with epilepsy. Proximagen, which exclusively owns the worldwide rights to naluzotan, will use the data from this clinical trial to support the development and commercialisation of the product.
Naluzotan is a 5-HT1a receptor agonist that was acquired by Proximagen in October 2009. In previous clinical trials, the compound was shown to be safe and well-tolerated in over 400 patients. Epilepsy patients with localisation-related epilepsy have reduced 5-HT1a receptor binding as indicated by positron emission tomography (PET scan). It is thought that by increasing neurotransmitter activity at 5-HT1a receptor sites, seizure incidence and severity may be decreased. This would represent a major breakthrough for sufferers of epilepsy, a disease affecting approximately 50 million people worldwide.
Commenting on the collaboration with the NIH, Kenneth Mulvany, chief executive officer of Proximagen, said, “We are very excited to be collaborating with the National Institute of Neurological Disorders and Stroke on this phase-II clinical trial. The signing of the CRADA supports our view taken at the time of the acquisition of naluzotan that the compound could be effective in reducing the incidence of seizures in patients suffering from epilepsy. Following the acquisition of tonabersat in February 2010, Proximagen now has two phase-II epilepsy programmes with novel mechanisms of action which have been shown to be safe and well-tolerated in humans. Phase-II clinical trials for both programmes are being funded by our partners while Proximagen retains the worldwide marketing rights to naluzotan and the European marketing rights to tonabersat.”
William H Theodore MD, chief of the Clinical Epilepsy Section at NINDS added, “We welcome the opportunity to collaborate with Proximagen on naluzotan, and assess its potential in a clinical setting as a treatment for epilepsy. It offers a potentially novel therapy based on pre-clinical and human imaging data and we are hopeful that we can show naluzotan to be efficacious in helping reduce seizures.”
Commenting on the news, Graham Faulkner, chief executive of the National Society for Epilepsy, said, “We are delighted to see further research into novel therapeutics, such as naluzotan, taking place. Epilepsy affects over 450,000 people in the United Kingdom alone and the need to identify treatments that are more effective and better tolerated than existing therapies remains pressing.”
Proximagen is a leading biotechnology company committed to developing novel drugs and innovative new treatments for disorders of the central nervous system, bringing new hope to patients and value to our shareholders.
Naluzotan is a 5-HT1a receptor agonist that has been shown to be safe and well tolerated in over 400 patients and it will be entering into phase II clinical development for epilepsy.