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