DGAP-News: PAION AG: RESULTS OF PHASE II STUDY OF REMIMAZOLAM (ONO-2745/CNS 7056), A SHORT-ACTING GENERAL ANESTHETIC
(firmenpresse) - DGAP-News: PAION AG / Key word(s): Research Update
PAION AG: RESULTS OF PHASE II STUDY OF REMIMAZOLAM (ONO-2745/CNS
7056), A SHORT-ACTING GENERAL ANESTHETIC
14.05.2012 / 09:00
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RESULTS OF PHASE II STUDY OF REMIMAZOLAM (ONO-2745/CNS 7056), A SHORT-ACTING
GENERAL ANESTHETIC
Aachen (Germany), 14 May 2012 - PAION AG (ISIN DE000A0B65S3; Frankfurt
Stock Exchange General Standard: PA8) today announced that its Japanese
development partner, Ono Pharmaceutical Co., Ltd. ('Ono') has informed
PAION AG, that it has completed a phase II clinical study of Remimazolam
(development codes: ONO-2745/CNS 7056), which has been developed by PAION
and now its development in Japan is promoted by ONO for general anesthesia.
The outline of the study results are shown below.
This study was conducted in Japan as an open-label study in surgery
patients undergoing general anesthesia in combination with analgesics.
Remimazolam was intravenously administered to 85 surgery patients 20 years
or older, with the purpose of induction of general anesthesia for 45
patients, and induction and maintenance of general anesthesia for 40
patients.
All 43 patients analyzed among the patients who received Remimazolam for
induction of general anesthesia achieved loss of consciousness and
underwent successful intubation, while all 32 patients analyzed among the
patients who received Remimazolam for induction and maintenance of general
anesthesia achieved loss of consciousness and underwent successful
intubation with successful completion of a surgery without need of rescue
therapy for sedative effects.
No adverse events of concern were observed. As expected in 98.8% of
patients adverse events were observed due to the nature of the intervention
(surgery), including primarily wound complication, laboratory test
abnormal, and blood pressure decreased, which correspond with relatively
common events typically observed in perioperative patients. There is no
concern on safety.
ONO entered into a license agreement with PAION in August 2007, acquiring
the exclusive rights to develop and market Remimazolam in Japan.
Dr. Mariola Söhngen, the Chief Medical Officer at PAION states: 'We
congratulate our partner ONO on the successful completion of the Phase II
study in anaesthesia, which could also support an accelerated development
of this indication in other territories. The data generated by Ono will be
an important contribution to the overall safety and efficacy database on
Remimazolam. We look forward to the further development of Remimazolam
through our partner Ono Pharmaceutical. '
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About PAION
PAION is headquartered in Aachen, Germany and has a second site in
Cambridge, UK. The company is specialised in developing innovative drugs
for the hospital-based treatment in indications for which there is a
substantial unmet medical need. PAION is extending its 'Search&Develop'
business model, by transforming into a 'Specialty Pharma Company', with a
focus on anaesthesia products.
About Ono
In keeping with its philosophy of 'Dedicated to Man's Fight against Disease
and Pain' Ono has always striven to achieve its goal of serving as an
R&D-oriented global speciality pharmaceuticals, aiming to develop
innovative and globally recognized drugs.
Ono offers a number of drugs in disease area where we have high medical
needs including a new class of drug for type II diabetes (Glactiv(R)
Tablet) and chemotherapy-induced nausea and vomiting (Emend(R) Capsule,
Proemend(R) for intravenous infusion) and a transdermal drug for
Alzheimer's disease (Rivastach(R) Patch).
About Remimazolam
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 in the
Intensive Care Unit (ICU).
PAION is currently exploring cooperation opportunities for the territories
outside Japan, where the compound is partnered with Ono Pharmaceutical.
Cooperations are vital for Paion in order to be able to progress the
further development of Remimazolam as soon as possible.
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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