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news.Proximagen Group, a biotechnology company focused on diseases of the central nervous system, has entered into a collaboration R&D agreement (CRADA) with the National Institute of Neurological Disorders and Stroke (NINDS) at the National Institutes of Health (NIH) in the US for development of Naluzotan, a 5-HT1a receptor agonist.
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As per the terms of the agreement, NINDS is expected to fully fund and carry out a double-blind, cross-over, placebo-controlled, Phase II clinical trial in patients with epilepsy, while Proximagen is expected to use data from this clinical trial to support the development and commercialisation of the product.
Proximagen, which owns exclusive rights to Naluzotan, has acquired the rights in October 2009.
The previous clinical studies conducted on Naluzotan demonstrated that the drug is safe and well-tolerated. Epilepsy patients with localisation-related epilepsy have reduced 5-HT1a receptor binding as indicated by positron emission tomography (PET scan).
Kenneth Mulvany, CEO of Proximagen, said: “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 new 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 marketing rights to Naluzotan and the European marketing rights to tonabersat.”
William Theodore, chief of the clinical epilepsy section at NINDS, said: “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 new 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.”
Graham Faulkner, chief executive of the National Society for Epilepsy, said: “We are delighted to see further research into new therapeutics, such as Naluzotan, taking place.”