PAION Initiates Phase Ib Study of the Anesthetic/Sedative CNS 7056 in Volunteers Undergoing Colonoscopy

* Reuters is not responsible for the content in this press release.

Mon Apr 20, 2009 1:30am EDT

* Aim of trial is to study a variety of (repeat-) doses to achieve an overall 30
min sedation time 
* Study also evaluates reversal of sedation with an established antagonist

AACHEN, Germany--(Business Wire)--
The biopharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock
Exchange, Prime Standard: PA8) today announces the start of a Phase Ib multiple
dose study with the new short-acting intravenous anesthetic/sedative CNS 7056 in
volunteers undergoing colonoscopy. 

The randomized, open, dose-escalation multiple dose Phase Ib study will evaluate
the sedation and recovery profile of CNS 7056 in volunteers undergoing
colonoscopy. In the first part of the study the reversal of sedation induced
with CNS 7056 by the benzodiazepine antagonist, flumazenil, will be examined in
a double-blind design. This approach is intended to provide further support for
an important safety feature for the compound, i.e. the opportunity to reverse
sedation when desired (e.g. in case of an inadvertent overdose). The first
volunteers have been included in this part of the study. 

In the subsequent open part of the trial volunteers will receive three different
dosages of CNS 7056 followed by "top ups" (i.e. multiple dose) as required to
maintain an adequate sedation level for 30 minutes whilst they undergo a
standard colonoscopy procedure. The study is being performed in the US and is
expected to complete before the end of 2009. 

PAION last week also had started a single-dose Phase II study examining sedation
of patients undergoing endoscopy of the upper gastrointestinal tract. The
necessity of performing these two studies is based on the differing length of
gastroscopy and colonoscopy interventions. The Phase Ib study with CNS 7056 will
allow PAION to generate additional data on pharmacodynamics and
pharmacokinetics. 

"The results of these two studies will be the basis for the further development
in procedural sedation. Performing a colonoscopy in a Phase I setting allows
mimicking the clinical routine setting. Thus this study will deliver information
usually generated in a Phase II study," commented Dr. Wolfgang Söhngen, PAION`s
CEO. "Our team has again demonstrated its strength in being able to achieve
significant steps in the clinical development in a very focused and efficient
way." 

About CNS 7056

CNS 7056 is a new short-acting sedative and general anesthetic that acts on
GABAA receptors. 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 GABAA receptor modulator interacting with
the benzodiazepine site. The clinical proof of concept study, reported in
January 2009, showed that, after intravenous administration, 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
anesthesia and as a sedative for mechanical ventilation in the Intensive Care
Unit (ICU). PAION plans to initiate partnering discussions in parallel to the
ongoing Phase II in order to initiate the further development of CNS 7056 for
territories outside Japan, where the compound is partnered to Ono
Pharmaceuticals. 

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
has a "Search & Develop" business model, which is based on its core expertise in
drug development. Where appropriate, particularly during the late stages of the
clinical development, PAION seeks to collaborate with experienced partners. 





PAION AG
Oliver Schulte, Investor Relations
Phone: +49 241 4453-154
E-mail: o.schulte@paion.com
www.paion.com
or
MC Services AG
Hilda Juhasz
Phone +49 89 210 228-20
E-mail: hilda.juhasz@mc-services.eu

Copyright Business Wire 2009

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