DGAP-News: PAION AG / Key word(s): Research Update
PAION ANNOUNCES INITIATION OF SECOND U.S. PHASE III CLINICAL TRIAL OF
REMIMAZOLAM FOR PROCEDURAL SEDATION DURING BRONCHOSCOPY
08.06.2015 / 14:00
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PAION ANNOUNCES INITIATION OF SECOND U.S. PHASE III CLINICAL TRIAL OF
REMIMAZOLAM FOR PROCEDURAL SEDATION DURING BRONCHOSCOPY
Aachen, 08 June 2015 - PAION AG, a Specialty Pharma Company (ISIN
DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announced
the initiation of the second pivotal U.S. Phase III clinical trial of
Remimazolam, an ultra-short-acting sedative/anesthetic, for procedural
sedation in patients undergoing bronchoscopy.
The current trial forms the second pivotal study of the Remimazolam Phase
III program. PAION and the U.S. Food and Drug Administration (FDA) have
agreed on the remaining development program (indications, size of studies
and design).
Wolfgang Söhngen, M.D., Ph.D., chief executive officer of PAION AG, said:
"The Phase III bronchoscopy study is intended to confirm the efficacy and
safety profile of Remimazolam in additional procedural sedation
applications with the intention of broadening the target patient population
and to achieve a broad label in procedural sedation. Because most patients
undergoing bronchoscopy have a pre-existing pulmonary disease,
Remimazolam's benign safety profile including its effect on the respiration
system is critically important to its success as a sedative for these
procedures. During Phase II clinical trials in colonoscopy and upper
endoscopy, Remimazolam had an excellent safety profile including
respiratory stability and was highly effective in providing sedation
resulting in successfully completed procedures."
This Phase III clinical trial is a prospective, double-blind, randomized,
placebo- and midazolam-controlled, U.S. multicenter study in 460 patients
undergoing bronchoscopies. Patients will be randomized to receive
Remimazolam, midazolam or placebo in addition to fentanyl to achieve
moderate sedation. The primary endpoint is the successful completion of the
bronchoscopy procedure with no requirement for an alternative sedative. The
completion of patient recruitment is expected in 2016.
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About Remimazolam
Remimazolam is an innovative ultra-short-acting general
sedative/anesthetic. As a result of its short duration of action and good
controllability, it has a preferable efficacy and safety profile relative
to other currently marketed anesthesia compounds. Remimazolam's rapid
offset is a consequence of its metabolism by tissue esterase enzymes that
are widely distributed throughout the body. While the key positioning in
conscious sedation will be a low impact on respiratory function it will be
cardiovascular stability for general anesthesia. Remimazolam has potential
in three indications:
- Procedural sedation (Lead indication U.S.)
- General anesthesia (Lead indication EU, Japan)
- ICU sedation (Phase 2 Japan)
Remimazolam is available for licensing outside China, Russia (CIS) Turkey,
MENA Region, South Korea and Canada, where the compound is partnered with
Yichang Humanwell, R-Pharm, TR-Pharm, Hana Pharm and Pendopharm.
About PAION
PAION AG is a publicly-listed Specialty Pharma Company headquartered in
Aachen, Germany with further sites in Cambridge, UK and New Jersey, US. The
company has a track record of developing hospital-based treatments for
which there is substantial unmet medical need. PAION's strategy is to
participate in the commercialization of Remimazolam and extend its business
with a focus on anesthesia/critical care products. Remimazolam is the
building block for its future marketing activities.
PAION 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@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.
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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@paion.com
Internet: www.paion.com
ISIN: DE000A0B65S3
WKN: A0B65S
Listed: Regulated Market in Frankfurt (Prime Standard); Regulated
Unofficial Market in Berlin, Dusseldorf, Hamburg, Munich,
Stuttgart
End of News DGAP News-Service
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364511 08.06.2015
DGAP-News: PAION ANNOUNCES INITIATION OF SECOND U.S. PHASE III CLINICAL TRIAL OF REMIMAZOLAM FOR PROCEDURAL SEDATION DURING BRONCHOSCOPY
| Source: EQS Group AG