PAI Paion

        
     PAION Announces Successful Completion of Phase I Study with the Sedative/Anaesthetic CNS 7056 
* Study completed ahead of schedule* No safety issues* Target profile expected to be met    The biopharmaceutical
company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8; London AIM: PAI) today announces
that it has successfully completed a Phase I study with its intravenous sedative/anaesthetic CNS 7056. The study was
completed ahead of schedule because the target criterion, more than 50% of the volunteers reaching loss of consciousness
for more than 5 minutes, was reached in the 9th of the 10 planned cohorts. No serious adverse events have been reported
to PAION. The company expects to report headline data of the study early in 2009, and will progress to the next stage of
development rapidly thereafter.
    Wolfgang S�hngen, CEO of PAION commented: "Within less than six months of the acquisition, we are now getting first
proof for the great potential of the CeNeS products. We now look forward to seeing the unblinded data in the near
future. As we have not received any negative reports during the study, we are confident that the profile of CNS 7056
will meet our expectations. With its expected quick on/off sedative profile and thus anticipated faster recovery, CNS
7056 could mark an important progress for a variety of indications. For the time being, we will focus on the use in
colonoscopy and upper gastrointestinal endoscopy through our own development efforts. With a partner on board, we may
also investigate additional indications to rapidly exploit the broad potential of this exciting project." 
    CNS 7056 is a new short-acting sedative/anaesthetic that acts on GABAAreceptors in the brain. Pre-clinical studies
demonstrated that, after intravenous administration, the compound quickly induces sedation. Importantly, the sedative
effects disappear extremely rapidly after cessation of administration.
    A total of 81 subjects were enrolled in the double-blind placebo-controlled Phase I study which was designed to
explore safety, tolerability and pharmacokinetics of single ascending doses of CNS 7056 in healthy volunteers.
Furthermore, the efficacy of the substance was ascertained by assessing the sedation of the volunteers. At the end of
each dosing cohort, the Data Monitoring Committee met to evaluate the study data prior to allowing escalation to the
next highest dose cohort, as appropriate. In addition, the study included a direct comparison with midazolam, the
standard drug used for procedural sedation. The inclusion of midazolam-treated volunteers permits the effective
evaluation of the competitive efficacy and safety profile of CNS 7056.
    CNS 7056 is initially being developed as a sedative agent for hospital and outpatient procedures, such as
endoscopies. It has further potential for the induction and maintenance of anaesthesia, for long term sedation in the
intensive care unit and other situations where the short half-life would present an advantage over existing
alternatives.
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     About CNS 7056 
    CNS 7056 is a new short-acting sedative and general anaesthetic that acts on GABAAreceptors. The substance was added
to PAION's portfolio by acquiring CeNeS who in turn had acquired the substance from GlaxoSmithKline. CNS 7056 is a
water-soluble, rapid and short-acting GABAAreceptor modulator interacting with the benzodiazepine site. Preclinical data
show that, after intravenous administration, CNS 7056 rapidly induces sedation which is maintained during continuous
administration. Importantly the sedative effects rapidly disappear after cessation of administration. The rapid offset
of effect of the compound is due to its metabolism by esterase enzymes that are widely distributed throughout the body.
Therefore it is anticipated that CNS 7056 can be clinically developed as a sedative agent for day case procedures, the
induction and maintenance of anaesthesia and as a sedative for mechanical ventilation in the Intensive Care Unit (ICU).
In 2007, CeNeS completed a license agreement for CNS 7056 with Ono Pharmaceuticals. Under this agreement, Ono will
develop and commercialize CNS 7056 for the Japanese territory.
     About PAION 
    PAION is a biopharmaceutical company headquartered in Aachen, Germany. Since the acquisition of CeNeS
Pharmaceuticals, which was completed in June 2008, the company has a second site in Cambridge, UK. The company is
specializing in developing and commercializing innovative drugs for the hospital-based treatment of central nervous
system (CNS) disorders and thrombotic/cardiovascular diseases, indications for which there is a substantial unmet
medical need. PAION intends to further expand its portfolio of drugs by exploiting its core expertise in identifying
high-potential compounds, licensing or otherwise acquiring them and advancing them through the clinical development and
regulatory approval process. Where appropriate, particularly during the late stages of the clinical development and
approval process and the commercialization phase, PAION seeks to collaborate with experienced partners.
 Contact
 Dr. Peer Nils Schr�der
 Director Corporate Communications & Investor Relations
 PAION AG
 Martinstrasse 10-12
 52062 Aachen - Germany
 Phone +49 241 4453-152
 E-mailpn.schroeder@paion.com
 www.paion.com
  
 Teathers
 Nomad and broker (AIM)
 Shaun Dobson/Claes Sp�ng
 Phone +44 20 7131 3000
    
    

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