PAION Completes First Part of Phase Ib Study of the Anesthetic/Sedative CNS 7056

* Reuters is not responsible for the content in this press release.

Mon May 11, 2009 1:30am EDT

* Effect of CNS 7056 can be reversed by antagonist flumazenil 
* No re-sedation observed after administration of flumazenil 
* Data strengthen safety profile of CNS 7056

AACHEN, Germany--(Business Wire)--
The biopharmaceutical company PAION AG (ISIN DE000A0B65S3; Frankfurt Stock
Exchange, Prime Standard: PA8) today announces the positive results of the first
part of the Phase Ib study with the new short-acting intravenous
anesthetic/sedative CNS 7056, which further strengthen the safety profile of the
compound. 

Following the successful proof of concept study reported in January 2009, the
randomized, open, dose-escalation multiple dose Phase Ib study further evaluates
the sedation and recovery profile of CNS 7056. Before commencing the second part
of the study in volunteers undergoing a standard colonoscopy procedure, the
reversal of sedation induced with CNS 7056 by the benzodiazepine antagonist,
flumazenil, has been examined in a double-blind design. In total, six volunteers
received a high single dose of CNS 7056 on two consecutive days. After
successful sedation the subjects either received flumazenil or matching placebo
on Day 1 and the alternate treatment on Day 2 in a randomized manner. The
results reveal that a single dose of flumazenil is able to reverse the effects
of CNS 7056 within approximately 1.5 minutes in volunteers with deep
sedation/loss of consciousness. Subsequent re-sedation after administration of
flumazenil was not observed. 

These data provide further support for an important safety feature of the
compound, i.e. the opportunity to reverse sedation/loss of consciousness when
desired (e.g. in case of an inadvertent overdose). 

"These data again confirm the high potential of our translational approach which
is based on the predictability of the animal data for this compound," commented
Dr. Wolfgang Söhngen, PAION`s CEO. "The fact that the volunteers do not
encounter a re-sedation after administration of flumazenil adds to the USP of
this compound and represents an important advantage over current treatment
options." 

In the subsequent open part of the trial which is currently ongoing, volunteers
undergoing a colonoscopy will receive different dosages of CNS 7056 followed by
"top ups" (i.e. multiple dose) as required to maintain an adequate sedation
level for 30 minutes. The study is being performed in the US and is expected to
complete before the end of 2009. 

### 

About CNS 7056
CNS 7056 is a new short-acting sedative and general anesthetic that acts on
GABAA receptors. The substance was added to PAION`s portfolio by acquiring CeNeS
who in turn had acquired the substance from GlaxoSmithKline. 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 ongoing Phase II in order to accelerate the further development of CNS
7056 for territories outside Japan, where the compound is partnered to Ono
Pharmaceuticals. 

About PAION
PAION 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. 





PAION AG
Ralf Penner
Director Investor Relations & Public Relations
Phone: +49 241 4453-152
E-mail: r.penner@paion.com
www.paion.com



Copyright Business Wire 2009

Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.