DGAP-News: PAION COMPLETES PHASE IIB STUDY WITH SHORT-ACTING ANESTHETIC/SEDATIVE REMIMAZOLAM (CNS 7056)
(firmenpresse) - PAION AG / Key word(s): Research Update
27.09.2010 07:32
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PAION COMPLETES PHASE IIB STUDY WITH SHORT-ACTING ANESTHETIC/SEDATIVE
REMIMAZOLAM (CNS 7056)
- Phase IIb study completed within 4 months
- Headline data expected by end of November
- No safety concerns
Aachen (Germany), 27 September 2010 - The biopharmaceutical company PAION
AG (ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today
announces the completion of the Phase IIb clinical trial assessing the new
short-acting intravenous anesthetic/sedative Remimazolam (CNS 7056) in
patients undergoing colonoscopy. No drug-related Serious Adverse Event has
been reported.
The Phase IIb trial was a double-blind, randomized, parallel group study
examining three doses of Remimazolam compared with Midazolam in 160
patients undergoing a colonoscopy. The patients received 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 - conducted in multiple sites in the U.S. - was designed to
evaluate the safety of Remimazolam and the success of the sedation, the
time to peak sedation as well as the time to full recovery and discharge,
in comparison to the gold-standard agent, Midazolam. In addition, based on
the results of the successfully concluded Phase Ib and IIa studies, this
study was aimed to further refine the optimal dose regimen before moving
into Phase III.
'It is anticipated that the excellent safety profile seen in previous
studies will be confirmed,' commented Dr. Wolfgang Söhngen, PAION's CEO.
'We will now carefully perform the steps required to provide the full data
set which will be important for our decisive partnering discussions.'
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About Remimazolam (CNS 7056)
Remimazolam is an innovative short-acting general anesthetic/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
anesthesia. It could also be used as a sedative for patients in the
Intensive Care Unit (ICU).
PAION is exploring partnering opportunities for the territories outside
Japan, where the compound is partnered with 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 Organization 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(at)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.
27.09.2010 07:32 Dissemination of a Corporate News, transmitted by DGAP -
a company of EquityStory AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
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Media archive at www.dgap-medientreff.de and www.dgap.de
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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(at)paion.com
Internet: www.paion.com
ISIN: DE000A0B65S3
WKN: A0B65S
Listed: Regulierter Markt in Frankfurt (Prime Standard); Freiverkehr
in Hamburg, München, Berlin, Düsseldorf, Stuttgart
End of Announcement DGAP News-Service
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Datum: 27.09.2010 - 07:32 Uhr
Sprache: Deutsch
News-ID 32254
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