PAI Paion

        
     PAION's Novel Sedative/Anaesthetic CNS 7056 Meets Target Profile in Human Proof of Concept Study 
* Sedation with fast and predictable on- as well as offset* Favourable safety profile* New Phase I/II studies in
preparation    The biopharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8;
London AIM: PAI) today reports the first human data of its intravenous sedative/anaesthetic CNS 7056. The Phase I proof
of concept study compared intravenous CNS 7056 to placebo and a standard dose of midazolam, the current gold standard
for procedural sedation. The anticipated favourable profile was observed and no safety issues were raised. Volunteers
treated with increasing doses of CNS 7056 were successfully sedated at the higher dose cohorts as expected and recovered
to full consciousness rapidly.
    A total of 81 subjects were enrolled in the double-blind placebo- and midazolam- controlled Phase I study. The study
was designed to explore the safety, tolerability and pharmacokinetics of single ascending doses of CNS 7056 in healthy
volunteers. Efficacy was ascertained by assessing the sedation of the volunteers by standardized methods.
Midazolam-treated volunteers were included to allow an initial assessment of the comparative efficacy and safety profile
of CNS 7056. The stopping criterion for the study was pre-determined as more than 50% of the volunteers reaching loss of
consciousness for more than 5 minutes. In the 9(th)out of 10 planned doses this criterion was met. No serious adverse
events occurred, even at doses that induced unconsciousness.
    Dose dependent sedation, with a rapid onset of effect, was observed after administration of CNS 7056 at doses of
0.05 mg/kg and higher. Doses of CNS 7056 (0.075 - 0.20 mg/kg) that induced peak sedation levels similar to or greater
than those achieved with midazolam (0.075 mg/kg) showed a markedly shorter duration of sedative effect with recovery
from sedation within approximately 10 minutes compared to approximately 40 minutes for midazolam. The peak sedative
effect of CNS 7056 was reached within four minutes in these dose groups, with initial onset of sedation being observed
after approximately one minute. For midazolam, the peak effect was reached after approximately 15 minutes. Duration and
depth of sedation increased with higher doses of CNS 7056, while the recovery was still earlier as compared to
midazolam.
    The company now plans one study with healthy volunteers in colonoscopies and one study with patients undergoing
upper gastrointestinal endoscopies. Both studies are expected to start no later than Q3 2009.
    CNS 7056 is an ester and pre-clinical studies showed that it is rapidly hydrolysed by tissue esterases to an
inactive metabolite. This mechanism of deactivation should result in a more predictable onset and offset profile
compared to that seen with drugs that are predominantly metabolized by the liver and, secondly, a lower risk of
pharmacokinetic drug interactions. Pharmacokinetic analysis from the current Phase I study confirmed that CNS 7056 was
rapidly converted to its inactive metabolite in man. The plasma clearance of CNS 7056 was approximately three times more
rapid than the clearance of midazolam. The pharmacokinetic profile of CNS 7056 was linear within the dose range
examined.
    PAION will now progress to the next stage of development and start seeking a partner for territories outside Japan
in parallel to the commencement of Phase II. In Japan, CNS 7056 is partnered with Ono Pharmaceuticals.
    Wolfgang S�hngen, CEO of PAION commented: "The positive data meet our expectations. We are positive that CNS 7056
could be a valuable alternative for procedural sedation by avoiding the potential for prolonged or overly deep sedation
thus potentially reducing the intensity of supervision needed. We will seek ways to explore its potential also in other
indications. It was especially re-assuring to see that sedation, to the level of unconsciousness, could be achieved
without safety concerns. PAION's management and project team are proud to see that these results confirm our high
expectations for the potential of this compound, which was in the pre-clinical development phase when we completed the
CeNeS acquisition last summer." 
      Note: An updated company presentation including the new data on CNS 7056 will be available on
www.paion.comstarting Monday, 12 January 2009.  
     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. After
intravenous administration to human volunteers, CNS 7056 rapidly induces sedation. 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-mail pn.schroeder@paion.com
 www.paion.com
or
Teathers
Nomad and broker (AIM)
Shaun Dobson/Claes Sp�ng
Phone +44 20 7131 3000
    
    

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