DGAP-News: PAION'S PARTNER ONO STOPPED ITS DOSE FINDING, EXPLORATIVE PHASE II TRIAL IN ICU SEDATION WITH REMIMAZOLAM AND PLANS TO ADAPT THE DOSE REGIME FOR A NEW STUDY
(firmenpresse) - DGAP-News: PAION AG / Key word(s): Research Update
PAION'S PARTNER ONO STOPPED ITS DOSE FINDING, EXPLORATIVE PHASE II
TRIAL IN ICU SEDATION WITH REMIMAZOLAM AND PLANS TO ADAPT THE DOSE
REGIME FOR A NEW STUDY
01.08.2013 / 12:39
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PAION'S PARTNER ONO STOPPED ITS DOSE FINDING, EXPLORATIVE PHASE II TRIAL IN
ICU SEDATION WITH REMIMAZOLAM AND PLANS TO ADAPT THE DOSE REGIME FOR A NEW
STUDY
- ONO initiated the dose finding, explorative phase II trial in ICU
sedation with Remimazolam in September 2012
- ONO plans to adapt the dose regime for a new study
- The clinical trials in General Anaesthesia are on track - the
recruitment of second study of Phase III program is completed (ASA III
or higher)
Aachen (Germany), 01 August 2013 - PAION AG (ISIN DE000A0B65S3; Frankfurt
Stock Exchange, General Standard: PA8), a biopharmaceutical company,
announced that it was informed by its partner ONO Pharmaceutical that it
has decided to stop the dose finding explorative Phase II trial in ICU
sedation.
Due to an unclear pharmacokinetic result in long-term administration in the
study, ONO has decided the discontinuation of the study. Overall all
patients were sedated successfully and no significant Adverse Events were
reported. The next step will be to perform a batch of pre-clinical
experiments, perform PK modelling based on the plasma samples and consider
if dose adjustment (reduced or changed) is necessary for new studies.
ONO furthermore confirmed that clinical trials in General Anaesthesia are
on track. The recruitment of the second study in the Phase III program
(American Society of Anesthesiologists classification III or higher) in
more severely sick patients has been completed. No significant Adverse
Events has been reported so far.
ONO entered into the license agreement with PAION UK Ltd. (former CeNeS
Limited) in 2007 to develop and commercialize Remimazolam in Japan and is
developing the substance for the Japanese market for both 'induction and
maintenance of anaesthesia' and 'ICU sedation'.
Dr. Wolfgang Söhngen, CEO of PAION, commented: 'We are again impressed by
the fact how fast Ono is driving the anaesthesia Phase III program forward.
ONO's decision to discontinue the ICU study shows the diligence with which
ONO is performing the program. ONO is committed to the program in ICU
sedation and plans to perform a new study. In addition we will be able to
collect data in our study in Europe, as part of the patients undergoing
Cardiac Surgery will be observed for up to 24h ICU sedation with
Remimazolam as compared to Propofol.'
###
About PAION
PAION AG is a publicly-listed biotech company headquartered in Aachen,
Germany with a second site in Cambridge, UK. The company has a track record
in developing hospital-based treatments for which there is substantial
unmet medical need. PAION AG is transforming its business model from a pure
development company to a specialty pharmaceutical company with a focus on
anaesthesia products to take advantage of the unique profile of its main
compound, Remimazolam.
About Remimazolam
Remimazolam is an innovative short-acting general anaesthetic/sedative. Due
to its short duration of action and good controllability, it has a
preferable efficacy and safety profile relativeto other currently marketed
anaesthesia compounds. The rapid offset of Remimazolam's effect is due to
its metabolism by tissue esterase enzymes that are widely distributed
throughout the body.
Remimazolam has potential in three indications:
- Procedural sedation
- General anaesthesia
- ICU sedation
Remimazolam is available for licensing outside Japan, China and South
Korea, where the compound is partnered with Ono Pharmaceutical and Yichang
Humanwell and Hana Pharm has an exclusive option.
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.
End of Corporate News
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01.08.2013 Dissemination of a Corporate News, transmitted by DGAP - a
company of EQS Group AG.
The issuer is solely responsible for the content of this announcement.
DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
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
Germany
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 (General Standard);
Freiverkehr in Berlin, Düsseldorf, Hamburg, München,
Stuttgart
End of News DGAP News-Service
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