DGAP-News: PAION AG / Key word(s): Research Update
PAION ANNOUNCES INITIATION OF US PHASE III CLINICAL TRIAL OF
REMIMAZOLAM FOR PROCEDURAL SEDATION DURING COLONOSCOPY
31.03.2015 / 13:00
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PAION ANNOUNCES INITIATION OF U.S. PHASE III CLINICAL TRIAL OF REMIMAZOLAM
FOR PROCEDURAL SEDATION DURING COLONOSCOPY
- Remimazolam's U.S. Phase III program to include two pivotal trials and
one smaller safety trial launching in 2015
- Patient recruitment for Phase III in colonoscopy is expected to
complete before end of 2015
Aachen, 31 March 2015 - PAION AG, a Specialty Pharma Company (ISIN
DE000A0B65S3; Frankfurt Stock Exchange Prime Standard: PA8) today announced
the initiation of a U.S. Phase III clinical trial of Remimazolam, an
ultra-short-acting sedative/anesthetic, for procedural sedation in patients
undergoing colonoscopy.
During Phase II clinical trials, Remimazolam displayed faster onset of
sedation and greater procedural success compared to midazolam. Remimazolam
showed a benign safety profile and patients experienced rapid recovery from
sedation including faster recovery of cognitive function as compared to
midazolam. The initiation of the Phase III trial in patients undergoing
colonoscopies marks the start of PAION's Phase III clinical program, which
includes a second pivotal Phase III trial in patients undergoing
bronchoscopies and a third smaller safety trial in high-risk patients
undergoing colonoscopies. In parallel, PAION will conduct three Phase I
studies.
Wolfgang Söhngen, M.D., Ph.D., chief executive officer of PAION AG, said:
"The initiation of the Phase III trial in patients undergoing colonoscopy
is an important milestone for PAION. We expect the current study to further
confirm Phase II data that showed Remimazolam was safe and highly effective
in providing procedural sedation. Midazolam has been selected as a
comparator because PAION aims to get a label similar to Midazolam."
Greg Papaz, president and chief executive officer of PAION, Inc., added:
"The change in the reimbursement of colonoscopies in the U.S. underscores
the medical need for an alternative sedation agent. We expect Remimazolam
to compete with the safest prescribed sedatives and enable high-patient
throughput with a fast onset/rapid recovery, a profile currently unmet in
the anesthetic space."
This Phase III clinical trial is a prospective, double-blind, randomized,
placebo and midazolam-controlled, U.S. multicenter study in 460 patients
undergoing colonoscopies for diagnostic or therapeutic reasons. Patients
will be randomized to receive Remimazolam, midazolam or placebo in addition
to fentanyl to achieve moderate sedation. The primary objective of this
study is to investigate the short-term sedation, and hence the success of a
colonoscopy compared to placebo and midazolam. The primary endpoint is the
successful completion of the colonoscopy procedure with no requirement for
alternative sedative. The completion of patient recruitment is expected
before the end of 2015.
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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. Remimazolam has potential in
three indications:
- Procedural sedation (Lead indication U.S.)
- General anesthesia (Lead indication EU, Japan)
- ICU sedation (Phase II 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, U.S.
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 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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339335 31.03.2015
DGAP-News: PAION ANNOUNCES INITIATION OF US PHASE III CLINICAL TRIAL OF REMIMAZOLAM FOR PROCEDURAL SEDATION DURING COLONOSCOPY
| Source: EQS Group AG