PAION Announces Patient Recruitment for Phase IIa Study with its Short Acting Anesthetic/Sedative CNS 7056 Successfully Compl...
08 September 2009 - 3:30PM
Business Wire
The biopharmaceutical company PAION AG (ISIN DE000A0B65S3;
Frankfurt Stock Exchange, Prime Standard: PA8) today announces the
successful completion of the Recruitment for the Phase IIa clinical
trial assessing the new short-acting intravenous
anesthetic/sedative CNS 7056 in patients undergoing endoscopy of
the upper gastrointestinal tract.
“Again our development team has beaten our expectations. We will
be able to provide headline data by November,” commented Dr.
Wolfgang S�hngen, PAION’s CEO. “Based on the blinded data already
available there are no safety concerns and we expect that this
study will support the unique profile of this exciting
compound.”
Initiated in April 2009 the Phase IIa trial was a randomized,
double blind, midazolam controlled study examining three doses of
CNS 7056 compared with midazolam in 100 patients undergoing a
diagnostic endoscopy of the upper gastrointestinal tract. It was
designed to further evaluate the safety of CNS 7056 and the
success of sedation, as well as the time to full recovery and
discharge, in comparison to the gold-standard agent, midazolam.
In total 100 patients have been treated in 7 centers across the
US.
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About CNS 7056CNS 7056 is a new short-acting sedative and
general anesthetic that acts on GABAA receptors. CNS 7056 is a
water-soluble, rapid and short-acting GABAA receptor modulator
interacting with the benzodiazepine site. The clinical proof of
concept study, reported in January 2009, showed that, after
intravenous administration, CNS 7056 rapidly induces sedation.
Importantly the sedative effects rapidly disappear after cessation
of administration. The rapid offset of effect of the compound is
due to its metabolism by esterase enzymes that are widely
distributed throughout the body. Therefore it is anticipated that
CNS 7056 can be clinically developed as a sedative agent for day
case procedures, the induction and maintenance of anesthesia and
ICU sedation. PAION initiated partnering discussions in parallel to
the Phase IIa study in order to accelerate the further development
of CNS 7056 for territories outside Japan, where the compound is
partnered to Ono Pharmaceuticals.
About PAIONPAION is a biopharmaceutical company
headquartered in Aachen, Germany. Since the acquisition of CeNeS
Pharmaceuticals, which was completed in June 2008, the company has
a second site in Cambridge, UK. The company is specialized in
developing and commercializing innovative drugs for the
hospital-based treatment of central nervous system (CNS) disorders
and thrombotic/cardiovascular diseases, indications for which there
is a substantial unmet medical need. PAION has a “Search &
Develop” business model, which is based on its core expertise in
drug development. Where appropriate, particularly during the late
stages of the clinical development, PAION seeks to collaborate with
experienced partners.
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