EANS-News: SYGNIS Pharma AG SYGNIS announces last patient treated in its AXIS
2 efficacy Study
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Research & Development
Heidelberg (euro adhoc) - SYGNIS announces last patient treated in its AXIS 2
efficacy Study
Heidelberg, 03 November 2011 - SYGNIS Pharma AG (Frankfurt: LIOK; ISIN
DE000A1E9B74; Prime Standard), a clinical stage biotech company researching and
developing innovative CNS treatments, today announced the completion of the
treatment for its randomized, double-blind study designed to demonstrate the
efficacy of AX200 for the treatment of patients with acute ischemic stroke
(AXIS 2). 328 patients have been treated across eight European countries.
AX200 has a dual mechanism-of-action in the treatment of acute stroke, stopping
neuronal cell death and promoting the regeneration of the damaged CNS tissue,
providing a new, first-in-class approach to treating stroke patients.
Dr. Frank Rathgeb, Chief Medical Officer of SYGNIS, commented: "We are pleased
to have completed treatment in our clinical phase II efficacy study and are now
finalizing the data collection. We expect to report initial findings of the
AXIS 2 Study towards the end of 2011".
Going forward, SYGNIS will review the options for the development and marketing
of AX200. Possibilities include continuing development by the company itself or
through outlicensing to external parties. In addition, SYGNIS will consider
developing AX200 together with a partner.
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 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 Phillips
FTI Consulting
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