MAHWAH, N.J., June 8, 2015 /PRNewswire/ -- PAION, Inc., a
wholly owned subsidiary of PAION AG, today announced the initiation
of the second pivotal U.S. Phase 3 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 3 program. PAION and the U.S. Food and Drug
Administration (FDA) have agreed on the remaining development
program (indications, size of studies and design).
Greg Papaz, president and chief
executive officer of PAION, Inc., said: "The Phase 3
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 2 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 3 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.
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.
For more information please visit www.paion.com
PAION Corporate Contact
Greg
Papaz
President and CEO
PAION, Inc.
201-512-8850
g.papaz@paion.com
Media Contact
Matt Middleman, M.D.
Russo Partners
212-845-4272
matt.middleman@russopartnersllc.com
PAION AG 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
Investor Relations Support in the US
The Trout
Group
Thomas Hoffman
+1 646 378 2931 Direct
thoffmann@troutgroup.com
www.troutgroup.com
Disclaimer:
This release contains certain forward-looking statements
concerning the future business of PAION, Inc. These forward-looking
statements contained herein are based on the current expectations,
estimates and projections of PAION, Inc'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, Inc. has no
obligation to periodically update any such forward-looking
statements to reflect future events or developments.
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SOURCE PAION, Inc.
