DGAP-News: PAION STARTS PHASE II STUDY WITH REMIMAZOLAM IN THE INDICATION ANAESTHESIA
(firmenpresse) - DGAP-News: PAION AG / Key word(s): Research Update
PAION STARTS PHASE II STUDY WITH REMIMAZOLAM IN THE INDICATION
ANAESTHESIA
09.09.2013 / 07:30
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PAION STARTS PHASE II STUDY WITH REMIMAZOLAM IN THE INDICATION ANAESTHESIA
- Initiation of European development program in general anaesthesia
- First patients successfully treated in Heart Center Leipzig
- Study results expected in H1 2014
Aachen (Germany), 09 September 2013 - PAION AG (ISIN DE000A0B65S3;
Frankfurt Stock Exchange General Standard: PA8) a biopharmaceutical
company, announced today the start of a Phase II clinical trial with the
short-acting anaesthetic/sedative Remimazolam in the indication
'anaesthesia' in patients undergoing cardiac 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 patients
undergoing major cardiac surgery. After surgery a follow up sedation in the
recovery room or the intensive care unit (ICU) for up to 24 h will take
place. A total of 90 patients will be treated. Results of the study are
expected in the first half of 2014.
The study is carried out at the Heart Center Leipzig, which follows the
'fast track' approach in anaesthesia. The aim of the concept is to restore
the patient as quickly as possible i.e. a rapid weaning from mechanical
ventilation (extubation) within 6 hours after surgery. This concept
provides a significant clinical and health economic benefit through
shortening extubation times after surgery leading to better patient
outcomes, reduced stay on the ICU and in the hospital. Next to the benefit
for the patients this leads to a substantial reduction in resource use for
the hospital. The aim is to establish Remimazolam as a key component of
this approach.
The study is designed to provide detailed information about the
cardiovascular safety profile of Remimazolam as an anaesthetic during
general anaesthesia for cardiac surgery. Furthermore it is expected to
deliver clear insights on early and predictable offset of its effect as
well as easy titration of sedation in the postoperative phase.
Two doses of Remimazolam will be evaluated against each other and against
propofol during induction of general anaesthesia. In addition, Remimazolam
will be tested during the maintenance phase of anaesthesia against the
combination of propofol and sevoflurane with respect to efficacy and
safety. Data in the postoperative sedation phase in the recovery room or
ICU will also be obtained for further exploration of the ICU sedation
indication. The study was designed such that the data can be compared with
the anaesthesia study conducted by Ono in Japan.
Dr. Wolfgang Söhngen, CEO of PAION, commented: 'Based on Ono's impressive
progress we can now jumpstart the European lead indication anaesthesia. We
are pleased to be able to do this in a center of excellence for cardiac
surgery as this highlights the high expectations of Remimazolam's profile.
We firmly believe that the current study in an area of high medical need
will enhance the perception of Remimazolam's potential.'
Dr. Stefan Probst, study director from the Heart Centre Leipzig, commented:
'In the field of anaesthesia and particularly in cardiac surgery and
intensive care there is aneed for well-tolerated controllable anaesthesia
drugs due to the increasing life expectancy of the population and the
associated increase in the number of elderly patients. Remimazolam has a
great potential to cover these requirements. '
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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
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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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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