DGAP-News: PAION STARTS PHASE Ib STUDY IN HAEMOPHILIA WITH SOLULIN

DGAP-News: PAION AG / Key word(s): Research Update
PAION STARTS PHASE Ib STUDY IN HAEMOPHILIA WITH SOLULIN

29.08.2011 / 07:30

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PAION STARTS PHASE Ib STUDY IN HAEMOPHILIA WITH SOLULIN

  - New approach for the treatment of haemophilia 

  - Results of treating patients with severe haemophilia expected in 2012

Aachen (Germany), 29. August 2011 - The biopharmaceutical company PAION AG
(ISIN DE000A0B65S3; Frankfurt Stock Exchange, Prime Standard: PA8) today
announces the start of a Phase Ib study with its recombinant human
thrombomodulin Solulin in the indication of haemophilia.

This Phase Ib study is an open label, randomized, multicenter, dose finding
study evaluating the safety, pharmacokinetics and pharmacodynamics of
single intravenous doses of Solulin in patients with severe haemophilia A
receiving chronic therapy with coagulation factor VIII.

Current treatment options are sub-optimal since frequent intravenous
injections are required. A so far unresolved problem is the resistance to
the coagulation factors evoked by the formation of antibodies, so-called
'inhibitors'. Therapy with clotting factors does not normalise bleeding
tendency in all cases which is caused by premature break-down of the small
clots needed to stop the bleeding.

New approaches in development are mainly designed to increase the currently
rather short half-life of the coagulation factors. This is aimed at
reducing the frequency of injections and increasing the time for which safe
and effective levels of the coagulation factors are present. It is the
ability of Solulin to stabilise clots by decreasing fibrinolysis which
enables this alternative approach to haemophilic treatment.

Solulin would be ideal in combination with coagulation factors as its
longer half life (up to 30 h shown in Phase I) would enable a safer
coagulation state to be kept for a longer period of time, thus reducing the
frequency of clotting factor injections. Its mode of action is
complementary to Factors VIII and IX and so an improved outcome for the
patient can be expected (i.e. reduced bleeding events).

Dr Wolfgang Söhngen, CEO of PAION commented, 'Solulin has the potential to
be a game changer as its innovative mechanism of action provides a new
complementary treatment modality and thus improves the quality of life of
patients with this serious medical condition.' In addition Dr Wolfgang
Söhngen commented, 'Our guidance for a cash reach until mid 2012 includes
the performance of the study.'

First results of the study are expected in 2012.

###

About haemophilia 
Haemophilia manifests itself as the inability to form stable blood clots
when blood vessels are damaged leading to prolonged and recurrent bleeding.
This is not only a problem in the case of obvious external damage to the
body or during surgery, but also in daily life due to normal wear and tear.
Such stresses are particularly common in the joints and so can lead to
joint deformities and arthropathy. When inadequately treated, by bleeding
into vital organs haemophilia can be fatal in childhood or early adult
life.

Haemophilia is caused by a lack of certain coagulation factors, mostly
Factor VIII and, less frequently Factor IX. Such deficiency results in less
clotting but also increased fibrinolysis.

There are estimated to be 400,000 haemophilia sufferers world-wide, with
approximately 22,000 in Europe and 20,000 in the USA. Approximately 80% of
sufferers lack Factor VIII (haemophilia A) and 20% lack Factor IX
(haemophilia B). As both conditions are recessive genetic conditions linked
to the X chromosome it almost only affects males.

About Solulin
Solulin is an improved variant of the human protein thrombomodulin, an
important natural regulator of the clotting system. One of the functions of
thrombomodulin is to stabilize the initial fibrin clot to stop bleeding.
Other than native thrombomodulin which is anchored in the wall of blood
vessels, Solulin can enter the blood stream to reach its potential site of
action. In low concentrations Solulin is able to stabilise blood clots and
to support coagulation.

Solulin already has been successfully tested in a Phase I study which
confirmed the excellent safety profile of the substance. Besides
haemophilia, the development of Solulin for the treatment of radiation
injury could be a suitable option.

About PAION
PAION is a biopharmaceutical company headquartered in Aachen, Germany and
has a second site in Cambridge, UK. The company is specialized in
developing and commercializing innovative drugs for the hospital-based
treatment in 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.

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:      Regulierter Markt in Frankfurt (Prime Standard);      
             Freiverkehr in Berlin, Düsseldorf, Hamburg, München,  
             Stuttgart                                             
 
 
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