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
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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:
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