KeyNeurotek Pharmaceuticals AG Reports Positive Phase I Data of Its Cannabinoid Receptor-Agonist

Magdeburg, (PresseBox) - KeyNeurotek Pharmaceuticals AG, a biotechnology company focused on the development and marketing of drugs against autoimmune diseases and degenerative disorders of the central nervous system (CNS), today announced positive results of a Phase I study with its cannabinoid receptor-agonist KN38-7271. KN38-7271 is being developed for the treatment of patients suffering from acute neurodegenerative incidents like a stroke or traumatic brain injuries. All study endpoints were successfully met.

The placebo-controlled, double blind, dose escalating study was performed in 18 healthy individuals. Primary objective of this Phase I study was to investigate the safety and tolerability of the drug given as a single intravenous infusion over 24 hours, whereas pharmacokinetic and pharmacodynamic effects of KN38-7271 were defined as secondary endpoints.

KN38-7271 was found to be safe and well tolerated at both doses tested, i.e. 1.5 and 3.0 µg/24 h. The pharmacokinetic analysis revealed a doubling of the KN38-7271 concentration in the blood serum with doubling of the drug dose. Dose-normalised parameters as Cmax and AUC were comparable for both dose levels used. The apparent terminal half-life (9-15 h for the low dose and 14-22 h for the high dose) and also the related apparent volume of distribution during terminal phase increased with the higher dose. The pharmacodynamic effects of KN38-7271 were generally inconspicuous.

KN38-7271 is already being tested by KeyNeurotek Pharmaceuticals in an international Phase II study in patients with traumatic brain injury (TBI) since the end of 2006. The cannabinoid receptor agonist activates both CB1 and CB2 receptors in the brain, strengthening important natural protection mechanisms and preventing overacting inflammatory reactions. Dr Frank Striggow, CEO of KeyNeurotek Pharmaceuticals AG, said: We are very pleased about the positive results of this dose-escalating Phase I trial. These data provide a maximum of flexibility to perform further dose-finding Phase II trials in patients suffering from stroke and/or TBI."

KeyNeurotek Pharmaceuticals AG

KeyNeurotek Pharmaceuticals, a privately held biotechnology company, was founded in 2000 within the Magdeburg, Germany, region, one of the leading centres of neuroscience in Europe.

The company pursues a number of drug candidates in various preclinical and clinical stages. The most advanced compound, KN38-7271, a cannabinoid receptor agonist, is in a Phase IIa trial in comatose patients with traumatic brain injury. At present, there is no targeted therapy for these patients.

KeyNeurotek Pharmaceuticals has unique functional and tissue-based high throughput screening platforms for compatible ex vivo and in vivo studies (TELOMICSTM). Based on its know-how, KeyNeurotek develops innovative therapies for the treatment of various neurodegenerative diseases of the central nervous system, such as traumatic brain injury (TBI), stroke, Alzheimer's disease and urinary incontinence/overactive bladder.

The company has built a strong network with renowned local and international partners, including, among others, the Leibniz Association, the Max Planck Society and Fraunhofer Society, Evotec, Schwarz Pharma/UCB, Bayer Schering and Gruenenthal. KeyNeurotek has been awarded the Hugo-Junckers Innovation Award of the State of Sachsen-Anhalt in 2002 and 2004 and the Innovation Award of the German Industry in 2006.

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