DGAP-News: PAION REACHES AGREEMENT WITH FDA ON PHASE IIB STUDY DESIGN FOR ITS SHORT-ACTING ANAESTHETIC/SEDATIVE CNS 7056 IN PATIENTS UNDERGOING COLONOSCOPY

PAION AG / Research Update

27.04.2010 07:32 

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PAION REACHES AGREEMENT WITH FDA ON PHASE IIB STUDY DESIGN FOR ITS
SHORT-ACTING ANAESTHETIC/SEDATIVE CNS 7056 IN PATIENTS UNDERGOING
COLONOSCOPY

  - Regulatory pathway cleared to start Phase IIb study

  - Study initiation expected within one month

Aachen (Germany), 27 April 2010 - The biopharmaceutical company PAION AG
(ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today
announces that it has reached an agreement with the FDA on the design of
the planned Phase IIb study with its new short-acting intravenous
anaesthetic/sedative CNS 7056 in patients undergoing colonoscopy. PAION
expects to initiate the study within a month.

The study will be conducted in multiple sites in the US. It is designed to
evaluate the safety and pharmacokinetics of CNS 7056 as well as the success
of the sedation, the time to peak sedation and the time to full recovery
and discharge, in comparison to the gold-standard agent, midazolam.

The Phase IIb trial is a double-blind, randomized, parallel group study
examining three doses of CNS 7056 compared with midazolam in 160 patients
undergoing a colonoscopy. The patients will receive one of three different
doses of CNS 7056 or midazolam followed by 'top-ups' as required to
maintain an adequate sedation level to undergo a standard colonoscopy
procedure.

Approximately nine months are scheduled for the patient recruitment phase.
Based on the results of the successfully concluded Phase Ib and IIa
studies, this Phase IIb study is aimed to further refine the optimal dose
regimen before moving into Phase III.

'Our team has done an excellent job in coming to an agreement with the FDA
in such a short period of time,' commented Wolfgang Söhngen, CEO of PAION.
'We are looking forward to achieve the next value inflection point for our
key value driver.'

###

About CNS 7056 

CNS 7056 is an innovative short-acting general anesthetic/sedative that is
initially being developed for use in minor medical interventions
(procedural sedation). Sedatives are used, for example, in endoscopic
procedures such as colonoscopies. After intravenous administration CNS 7056
rapidly induces the desired sedation. Importantly, this sedative effect
quickly disappears. This rapid offset of the effect is due to its
metabolism by tissue esterase enzymes that are widely distributed
throughout the body. CNS 7056 is being developed as a sedative agent for
day case procedures and for the induction and maintenance of anesthesia. It
could also be used as a sedative during artificial respiration in the
Intensive Care Unit (ICU).

CNS 7056 is licensed to ONO Pharmaceutical for the Japanese market. PAION
is exploring partnering opportunities for the territories outside Japan, in
order to be able to initiate the development of CNS 7056 in other
indications as early as possible.

About PAION

PAION is a biopharmaceutical company headquartered in Aachen, Germany and
with a second site in Cambridge, UK.

The company is focusing on the clinical development of drug candidates for
diseases or interventions 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.

Contact

Ralf Penner

Director Investor Relations & Public Relations

PAION AG

Martinstrasse 10-12

52062 Aachen - Germany

Phone: +49 241 4453-152

E-mail: r.penner@paion.com

www.paion.com

Disclaimer:

This release contains certain forward-looking statements concerning the
future business of PAION AG. These forward-looking statements contained
herein are based on the current expectations, estimates and projections of
PAION AG's management as of the date of this release. They are subject to a
number of assumptions and involve known and unknown risks, uncertainties
and other factors. Should actual conditions differ from the Company's
assumptions, actual results and actions may differ materially from any
future results and developments expressed or implied by such
forward-looking statements. Considering the risks, uncertainties and other
factors involved, recipients should not rely unreasonably upon these
forward-looking statements. PAION AG has no obligation to periodically
update any such forward-looking statements to reflect future events or
developments.


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Language:     English
Company:      PAION AG
              Martinstr. 10-12
              52062 Aachen
              Deutschland
Phone:        +49 (0)241-4453-0
Fax:          +49 (0)241-4453-100
E-mail:       info@paion.com
Internet:     www.paion.com
ISIN:         DE000A0B65S3
WKN:          A0B65S
Listed:       Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
              in Berlin, Düsseldorf, München, Hamburg, Stuttgart
 
End of News                                     DGAP News-Service
 
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