EANS-News: SYGNIS Pharma AG / 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
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
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
Stuttgart / free trade
Düsseldorf / free trade
Hannover / free trade