SYGNIS announces Data Safety Monitoring Board Recommendation for Phase II efficacy study for AX200

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Research & Development

Heidelberg (euro adhoc) - SYGNIS announces Data Safety Monitoring Board Recommendation for Phase II efficacy study for AX200

- more than 50% of the AXIS 2-patients recruited
      - top-line data expected in the second half of 2011

Heidelberg,  22  December  2010  -  SYGNIS  Pharma  AG  (Frankfurt:   LIOK;  ISIN DE000A1E9B74; Prime Standard),  a  clinical  stage   biotech  company  developing innovative CNS treatments, today announced  that  the  independent  Data  Safety Monitoring Board (DSMB) for the  Phase  II  efficacy  study  of  AX200  for  the treatment of acute ischemic Stroke  (AXIS  2)  has  recommended  the unmodified continuation of the trial. AX200 is SYGNIS´ most advanced drug candidate.

Based on the data of 50% of  the  AXIS  2-patients  the  DSMB  held   its  second interim  review.  As  the  available    study-results     have    shown    that    the administration of AX200 is safe and  well   tolerated  in  the  patients  treated within the study, the DSMB´s recommendation is to  continue  the  study  without any modification or restriction.

The role of the DSMB is to monitor, periodically, the  data  emerging from  the study to determine whether there are safety issues arising that  would  warrant modification of the protocol or early termination of  the  study.  The  DSMB  is independent of SYGNIS and any party related to SYGNIS.

AXIS 2 is a randomised double-blind study involving a  total  of  328 patients; half of the patients are treated with AX200, while the other  half  is  given  a placebo. The study is designed to demonstrate the  efficacy  of  AX200  for  the treatment of patients with acute ischemic stroke compared with a placebo  group. Patients are enrolled in the study up to nine hours after the  occurrence  of a stroke, with the study  medication  administered  as  a  continuous intravenous (i.v.) infusion for a period of three days. The trial was initiated in May  2009 and involves more than 70 sites  in  eight   European  countries.  Based  on  the latest preclinical data the study protocol was modified in spring 2010  to  also allow recruitment of patients previously treated with rt-PA.

Dr Frank  Rathgeb,  Chief  Medical  Officer  of  SYGNIS,  said:   "This  news  is certainly confirming our high expectations regarding the  safety  of  AX200  and the quality of the AXIS 2 study. There is good reason to continue the  study  as planned and to confirm our planning to report the top-line data  in  the  second half of 2011."

About SYGNIS Pharma SYGNIS Pharma AG, headquartered in Heidelberg,   is  a  specialty  pharmaceutical company listed on the Prime Standard of the German 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. SYGNIS´ strategy for growth includes the development of new  products from its own research and through in-licensing and acquisitions.

For further information please contact: SYGNIS Pharma AG: Dr. Franz-Werner Haas Vice President Operations +49 (0) 6221 454 812

Media-Contact: Julia Phillips 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.  ###

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Further inquiry note: Dr. Franz-Werner Haas Vice President Operations +49 (0) 6221 454 812

Branche: Biotechnology
ISIN:      DE000A1E9B74
WKN:        A1E9B7
Index:    CDAX, Prime All Share
Börsen:  Frankfurt / regulated dealing/prime standard
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Weitere Meldungen: SYGNIS AG

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