SYGNIS AG

EANS-News: SYGNIS Pharma AG
SYGNIS successfully completes patient recruitment for AXIS 2 Study

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Research & Development


Heidelberg (euro adhoc) - SYGNIS successfully completes patient recruitment for
AXIS 2 Study


    • 328 patients recruited at about 80 stroke centres in eight European
      countries
    • AX200 is one of the most advanced drug candidates worldwide for the
      treatment of stroke
    • Initial results of the AXIS 2 Study are expected towards the end of 2011
Heidelberg,  9  August  2011  -  SYGNIS  Pharma  AG   (Frankfurt:   LIOK;   ISIN
DE000A1E9B74; Prime Standard), a clinical stage biotech company researching  and
developing innovative CNS treatments, announced  the  successful  completion  of
the patient recruitment for  its  AXIS 2 Study.  This  randomized,  double-blind
study is  designed  to  demonstrate  the  efficacy  of  AX200  (G-CSF)  for  the
treatment of patients with acute ischemic stroke.

Dr. Frank Rathgeb, Chief Medical Officer of SYGNIS, said: "With  the  completion
of patient enrolment  we  have  reached  the  next  milestone  of  the  clinical
development of AX200 for the treatment of acute stroke: After the completion  of
a three month monitoring period of this last patient, we will enter the  crucial
evaluation phase during which we will analyse  all  collected  data  and,  as  a
result, gain clarity on the potential  of  AX200  for  the  treatment  of  acute
stroke. We expect to report initial  meaningful  findings  of  the  AXIS 2 Study
towards the end of 2011".

Prof. Ringelstein, Director of  Clinic  and  Policlinic  for  Neurology  of  the
University of Münster, commented: " AX200 provides a very promising approach  in
the field of the  acute  medical  treatment  of  stroke,  for  which  there  are
currently only few  and  time-limited  therapeutic  options  available.  In  the
Steering Committee  we  have  ensured  that  the  specific  challenges  of  this
indication as well as the  latest  scientific  findings  are  reflected  in  the
design of the AXIS 2 Study accordingly and that the execution of  the  Study  at
the renowned  stroke-centres  across  Europe  meets  the  highest  standards  of
quality. Accordingly, our  expectations  with  regard  to  the  results  of  the
AXIS 2 Study are high."

After the completion of a subsequent three  month  observation  period  for  the
last patient recruited, the data collection will be finalized. The data will  be
prepared (data-cleaning) and evaluated. Based on  these  findings,  SYGNIS  will
evaluate the options for the further development or commercialization of  AX200.
In this regard SYGNIS  might  start  an  additional  clinical  study,  aimed  to
confirm the efficacy of AX200 for the treatment of acute stroke,  by  itself  or
together with an appropriate pharma partner  or  out-license  the  entire  AX200
project.

SYGNIS is adequately equipped with financial resources. Taken into account  that
the Company will receive at least 6 million Euros as a  result  of  the  capital
increase, initiated in July 2011, SYGNIS is therefore financed until the end  of
calendar year 2012.




About the AXIS 2 Study

The AXIS 2 Study started in mid 2009 in about  80  renowned  stroke  centres  in
Germany, Austria, Belgium, Sweden, Spain, the Czech  Republic,  Poland  and  the
Slovak Republic. The Study included 328 stroke patients, the one half  of  which
has been treated with AX200 and the other half with  a  placebo.  Patients  were
enrolled up to nine hours after suffering a stroke  and  have  been  treated  by
infusion for a period of three days. Also patients were included into  the  AXIS
2 Study, who have received drug-based lysis therapy using  rt-PA  prior  to  the
treatment with AX200. AX200 is one of the most advanced drug candidates for  the
treatment of acute stroke worldwide.



About SYGNIS Pharma

SYGNIS Pharma AG, headquartered in Heidelberg,  is  a  specialty  pharmaceutical
company listed in the Prime  Standard  of  the  Frankfurt  Stock  Exchange.  The
Company is focused on the research and development of innovative  therapies  for
the treatment of disorders of the Central Nervous System. SYGNIS´ core  projects
are currently Acute Stroke for which SYGNIS´ lead clinical programme  is  AX200,
as well as the preclinical KIBRA-project for the treatment  of  different  forms
of dementia. All these disorders are characterized by  the  fact  that,  as  the
disease progresses, nerve cells are damaged and die.  Although  there  is  great
medical demand, there are currently no  or  only  inadequate  treatment  options
available. Furthermore, a key element of the sustainable value creation  of  the
Company is the expansion of the product pipeline, which will be secured  through
its own developments as well as in-licensing and acquisitions.




For further information please contact:

SYGNIS Pharma AG

      Dr. Franz-Werner Haas
      Senior Vice President Operations
      +49 (0) 6221 454 812
   franz-werner.haas@sygnis.de

Media Contact:
      Julia Philips
      Financial Dynamics
      Tel.: +44 (0) 20 7269 7187


###

Disclaimer
Some statements included in this  press  release,  relating  neither  to  proven
financial results nor other  historical  data,  should  be  viewed  as  forward-
looking, i.e. not definite. Such statements are  mainly  predictions  of  future
results, trends, plans or goals. These statements should not  be  considered  to
be total guarantees since given their very nature they are subject to known  and
unknown risks and imponderability and can be affected  by  other  factors  as  a
consequence of which the actual results, plans and goals  of  SYGNIS  Pharma  AG
may deviate greatly from the  established  conclusions  or  implied  predictions
contained in such statements. SYGNIS does not undertake to  publicly  update  or
revise these statements in the light of new information  or  future  results  or
for any other reason.
###


Further inquiry note:
Michael Wolf
Telefon: +49 (6221) 454 - 6
E-Mail: Michael.Wolf@sygnis.de

end of announcement                               euro adhoc 
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company:     SYGNIS Pharma AG
             Im Neuenheimer Feld 515
             D-69120 Heidelberg
phone:       +49 (0)6221 454-6
FAX:         +49 (0)6221 454-777
mail:     contact@sygnis.de
WWW:      http://www.sygnis.de
sector:      Biotechnology
ISIN:        DE000A1E9B74
indexes:     CDAX, Prime All Share
stockmarkets: regulated dealing/prime standard: Frankfurt, free trade: Berlin,
             Hamburg, Stuttgart, Düsseldorf, Hannover, München 
language:   English
 



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