KeyNeurotek Pharmaceuticals concludes patient recruitment in a Phase IIa traumatic brain injury study with KN38-7271 on schedule

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 that patient recruitment for its traumatic brain injury (TBI) study KN38-7271-001 has been completed on schedule. The European Phase-IIa-Study investigates the safety and tolerability of KeyNeurotek's lead candidate KN38-7271 in traumatic brain injury patients. In addition, the company is hoping for therapeutic efficacy signals. In the double blind, placebo-controlled study, KN38-7271 was administered at two different dose levels. Since November 2006, 97 patients with severe traumatic brain injury have been recruited in three European countries, including Germany. Results of the study are expected in summer 2009.

Traumatic brain injuries usually are caused by accidents or violence, and the death rate is dramatically increasing with the severity of the injury. Moreover, survivors carry a high risk of permanent neurological dysfunctions. At present, there is no medication available for treatment. KeyNeurotek Pharmaceuticals is among the leading developers of drugs for this indication.

Drug candidate KN38-7271 is characterized by a very innovative, dual mode of action. As a so-called cannabinoid receptor agonist, it activates CB1- and CB2-receptors on nerve and immune cells. It thereby enhances natural protection mechanisms and at the same time prevents critical inflammatory responses.

Already prior to this study in TBI patients, four Phase-I-studies with healthy volunteers have demonstrated that KN38-7271 is safe and well tolerated. In September this year, KeyNeurotek's compound was granted Orphan Drug Designation for the treatment of moderate to severe closed traumatic brain injury.

Dr Frank Striggow, CEO of KeyNeurotek Pharmaceuticals, said: We are very pleased about reaching this important milestone in a very challenging clinical study. Together with all our cooperation partners, we will now focus on the forthcoming completion and the analysis of this internationally leading study."

KeyNeurotek Pharmaceuticals AG

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