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KeyNeurotek Pharmaceuticals Reports Breakthrough In The Treatment Of Patients With Severe Traumatic Brain Injury In A Phase IIa Study
12/16/2009 11:31:06 AM
Magdeburg, December 16, 2009 – KeyNeurotek Pharmaceuticals AG, a biotechnology
company focused on the development of drugs against degenerative disorders of
the central nervous system and autoimmune diseases, today reports a positive outcome
of its Phase IIa study with KN38-7271 in patients with severe traumatic brain
injury (TBI). The data substantiate pharmacokinetics, safety and tolerability of the
substance – a dual cannabinoid receptor agonist – and show clear signs of therapeutic
efficacy in this indication. Currently, there is no pharmaceutical treatment available
to patients suffering from traumatic brain injuries.
The pharmacokinetic analysis of the clinical data shows that the study met its primary
endpoint, demonstrating a dose-dependent blood plasma concentration of KN38-
7271. In addition, KN38-7271 was found to be safe and well tolerated.
Most importantly, this is the first major clinical study investigating pharmaceutical interventions
in severe TBI, where several parameters suggest therapy-relevant efficacy
? Survival rate of patients receiving the study drug was statistically significantly
increased 30 days after start of treatment in both dosage groups.
? KN38-7271-treated patients, regardless of the dose applied, showed trends
toward a better neurological outcome, e.g. improved orientation and amnesia
3 or 6 months after TBI.
? The intracranial pressure (ICP) which is usually increased in TBI patients and
threatens survival of the brain, was lowered in KN38-7271-treated patients.
? Consistently, the slope of ICP elevation over the first days after TBI was flattened
and the time of the highest ICP was considerably delayed in the KN38-
? Cerebral perfusion pressure (CPP), which promotes oxygen and glucose supply
of the brain and needs to be maintained within certain limits, was positively
influenced in the drug-treated patients.
The study strongly supports the mode of drug action of KN38-7271 as a dual cannabinoid
CB1 and CB2 receptor agonist. This Phase IIa trial and met the highest
quality criteria in terms of patient recruitment, randomization and homogeneity as well
as protocol compliance, design, and a low number of patient withdrawals.
The double-blind, placebo-controlled proof-of-concept study included 97 adult comatose
TBI patients and was performed in three European countries, including Germany,
to investigate the pharmacokinetics, safety and efficacy of two dose levels of
KeyNeurotek’s lead compound KN38-7271.
Prof. Dr. med. Raimund Firsching, European coordinator of this study, stated:
"KeyNeurotek’s TBI study is clearly setting a quality benchmark. Besides, it is exciting
to see for the first time signs of potential drug efficacy on the basis of improved
survival of severe TBI patients."
Prof. Dr. med. Jürgen Piek, Coordinating investigator added: " This study conveys
a very comprehensive picture, underlining the therapeutic potential of KN38-
7271 and providing clear guidelines for the design of subsequent Phase II/III studies.”
Dr. Frank Striggow, CEO of KeyNeurotek Pharmaceuticals, summarized: “We are
extremely pleased with the quality and the outcome of this very important study which
has exceeded our expectation and is also encouraging for other indications such as
stroke. I would like to thank all KeyNeurotek employees and collaborators involved in
preparing, performing and analyzing this leading international study. Based on the
data and the Orphan Drug Designation of KN38-7271 for the treatment of moderate
and severe closed TBI, we will now talk to the European Medicines Agency about the
About Traumatic Brain Injury
Traumatic brain injuries are usually caused by accidents or assaults, and the death
rate is dramatically increasing with the severity of the injury. Moreover, survivors
carry a high risk of permanent neurological disabilities. With more than 700,000 hospitalized
patients in the USA and Western Europe, TBI is one of the major reasons
for death and severe disabilities among younger adults. It is also one of the major
injuries in military conflicts.
At present, there is no pharmaceutical treatment option available. KeyNeurotek
Pharmaceuticals is among the leading developers of drugs for this indication. The
potential annual market potential of drugs improving the clinical outcome of TBI patients
has been estimated to exceed US$1 billion.1
KeyNeurotek’s drug candidate KN38-7271 is characterized by an innovative, dual
mode of action. As a 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.
Four earlier Phase-I-studies with healthy volunteers have demonstrated that KN38-
7271 is safe and well tolerated. In September 2008, KeyNeurotek's compound was
granted Orphan Drug Designation for the treatment of moderate to severe closed
traumatic brain injury by the EU authorities.
About KeyNeurotek Pharmaceuticals AG
KeyNeurotek Pharmaceuticals, a privately held biotechnology company, was founded
in 2000 within the Magdeburg region in Germany, one of the leading centers of neuroscience
The company pursues a number of drug candidates in various preclinical and clinical
stages. The most advanced compound, KN38-7271, is in clinical development for TBI
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, stroke, Alzheimer's disease and urinary incontinence/overactive
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.