DGAP-News: PAION AG: GERMAN REGULATORY AUTHORITY APPROVED PHASE II STUDY OF REMIMAZOLAM IN INDICATION ANAESTHESIA
(firmenpresse) - DGAP-News: PAION AG / Key word(s): Research Update
PAION AG: GERMAN REGULATORY AUTHORITY APPROVED PHASE II STUDY OF
REMIMAZOLAM IN INDICATION ANAESTHESIA
05.08.2013 / 11:41
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PAION AG: GERMAN REGULATORY AUTHORITY APPROVED PHASE II STUDY OF
REMIMAZOLAM IN INDICATION ANAESTHESIA
- Final preparations for the start of the study
- Study results expected in H1 2014
Aachen (Germany), 05 August 2013 - PAION AG (ISIN DE000A0B65S3; Frankfurt
Stock Exchange General Standard: PA8) a biopharmaceutical company,
announced today, that the BfArM, the German regulatory authority has
granted approval for the Phase II clinical trial with the short-acting
anaesthetic/sedative Remimazolam in the indication 'anaesthesia' in
cardiovascular surgery.
The Phase II study is a randomized, propofol and sevoflurane (standard
treatment) controlled phase II study to evaluate the efficacy, safety and
pharmacokinetics of Remimazolam during general anaesthesia in cardiac
surgery patients. After surgery a follow up sedation in the recovery room
or the ICU for up to 24 h will take place. A total of 90 patients will be
treated. Currently, final preparations for the official start of the study
are ongoing. Results of the study are expected in the first half of 2014.
Dr. Wolfgang Söhngen, CEO of PAION, commented: 'I would like to thank the
entire internal and external international team of over 30 people who were
involved in the planning of this highly complex study. Now it is time to
perform the last logistical steps so that the study can begin quickly. Once
the recruitment has started, we will inform about further study details.'
###
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 relative to 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
numberof 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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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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