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

Press Release
 
 
May 08, 2008
 
KeyNeurotek Pharmaceuticals AG Reports Positive Phase I Data of Its
Cannabinoid Receptor-Agonist
 
Magdeburg, May 08, 2008 - 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."
 
About KeyNeurotek Pharmaceuticals AG
KeyNeurotek, a privately held biotechnology company, was founded in
2000 within the Magdeburg, Germany, region, one of the leading
centres of neuroscience in Europe.
 
KeyNeurotek 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.
 
The company 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 Healthcare and Gruenenthal. KeyNeurotek has
been awarded the Hugo-Junckers Innovation Award of the State of
Sachsen-Anhalt in 2002 and 2004 and the Innovation Price of the
German Industry in 2006.
 
Contact:
 

+-------------------------------------------------------------+
| Dr Frank Striggow | Dr Ludger Weß |
|   |   |
| KeyNeurotek Pharmaceuticals AG | akampion |
| ZENIT-Technologiepark | Saseler Loge 6b |
| Leipziger Str. 44 | D-22393 Hamburg |
| D-39120 Magdeburg | Germany |
| Germany |   |
|   | Tel. +49 40 88 16 59 64 |
| Tel.: +49 391 6117 220 | Mobile +49 160 96 65 29 58 |
| Fax: +49 391 6117 221 | ludger@akampion.com |
| frank.striggow@keyneurotek.de | www.akampion.com |
| www.keyneurotek.de | |
|   | |
+-------------------------------------------------------------+

 



 
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