EANS-News: SYGNIS Pharma AG / SYGNIS enters final stage with its Phase II efficacy study of AX200 for the treatment of acute stroke

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Research & Development

Heidelberg (euro adhoc) - SYGNIS enters final stage with its Phase II
efficacy study of AX200 for the treatment of acute stroke

- more than 75% of the AXIS 2-patients recruited
- Data Safety Monitoring Board confirms its recommendation for the
unmodified continuation of the trial
- top-line data expected in the second half of 2011

Heidelberg, 22 March 2011 - 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), which is responsible for monitoring safety issues with
regard to the execution of the Phase II efficacy study of
AX200 for the treatment of acute ischemic Stroke (AXIS 2), has held
its final interim review before the end of the trial and
recommended its unmodified continuation.

Based on the data of 75% of the 328 AXIS 2-patients the DSMB held
its third interim review. As the accessible study-data
continues to show the administration of AX200 is safe and well
tolerated by the patients, the DSMB confirmed its recommendation
of December 2010 when of 50% of all AXIS 2- patients were
recruited.

Dr Frank Rathgeb, Chief Medical Officer of SYGNIS, said:
"The patient recruitment for AXIS 2 has improved significantly in
recent months and the data continues to show AX200 has a good safety
profile. Therefore, we should be in a good position 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
Senior Vice President Operations
+49 (0) 6221 454 812
franz-werner.haas@sygnis.de

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. ###

end of announcement euro adhoc
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ots Originaltext: SYGNIS Pharma AG
Im Internet recherchierbar: http://www.presseportal.de

Further inquiry note:

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

Branche: Biotechnology
ISIN: DE000A1E9B74
WKN: A1E9B7
Index: CDAX, Prime All Share
Börsen: Frankfurt / regulated dealing/prime standard
Berlin / free trade
Hamburg / free trade
Stuttgart / free trade
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München / free trade