PAION AG / Research Update
02.08.2010 07:32
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PAION'S PHASE IIb STUDY WITH ITS ANAESTHETIC/SEDATIVE REMIMAZOLAM (CNS
7056) AHEAD OF SCHEDULE
- PAION expects to report results towards the end of 2010
- More than 50% patients already treated
Aachen (Germany), 2 August 2010 - The biopharmaceutical company PAION AG
(ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today
announces that the recruitment of the Phase IIb trial with its innovative
short-acting intravenous anaesthetic/sedative Remimazolam in patients
undergoing colonoscopy is considerably ahead of schedule; initially nine
months were estimated for the patient enrolment. More than 50% of the 160
patients have been treated since end of May 2010.
The Phase IIb trial is a double-blind, randomized, parallel group study
examining three doses of Remimazolam compared with midazolam in 160
patients undergoing a colonoscopy. The patients receive either one of three
different doses of Remimazolam or Midazolam followed by 'top-ups' (i.e.
multiple doses) as required to maintain an adequate sedation level to
undergo a standard colonoscopy procedure.
The study is being conducted in multiple sites in the U.S. It is designed
to evaluate the safety of Remimazolam and the success of the sedation, the
time to peak sedation, time to full recovery and discharge, in comparison
to the gold-standard agent, midazolam. PAION expects to report results
towards the end of 2010.
Based on the successful Phase Ib and IIa studies, this Phase IIb study of
Remimazolam will further refine the optimal dose regimen before moving into
Phase III trials.
'We have been able to recruit patients faster than expected and therefore
will deliver results possibly towards the end of 2010. Our collaborators
and our
team have done a great job in exceeding our own expectations,' commented
Wolfgang Söhngen, CEO of PAION. 'These data are expected to be the
triggering signal in the partnering process.'
###
About Remimazolam (CNS 7056)
Remimazolam is an innovative short-acting general anaesthetic/sedative.
Sedatives are used, for example, in endoscopic procedures such as
colonoscopies. After intravenous administration Remimazolam rapidly induces
the desired sedation. Importantly, this sedative effect quickly disappears.
This rapid offset of the effect of the substance is due to its metabolism
by tissue esterase enzymes that are widely distributed throughout the body.
Remimazolam is being developed as a sedative agent for day case procedures
(procedural sedation) as well as for the induction and maintenance of
anaesthesia. It could also be used as a sedative for patients on
ventilation in the Intensive Care Unit (ICU).
PAION is exploring partnering opportunities for the territories outside
Japan, where the compound is partnered to Ono Pharmaceuticals in order to
be able to initiate the development of Remimazolam in other indications as
early as possible.
As recently published, the INN (International Nonproprietary Name) for CNS
7056 recommended by the World Health Organisation is Remimazolam.
About PAION
PAION is a biopharmaceutical company headquartered in Aachen, Germany and
has a second site in Cambridge, UK. The company is specialized in
developing and commercializing innovative drugs for the hospital-based
treatment in 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.
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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DGAP-News: PAION'S PHASE IIb STUDY WITH ITS ANAESTHETIC/SEDATIVE REMIMAZOLAM (CNS 7056) AHEAD OF SCHEDULE
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