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 2011Heidelberg, 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 --------------------------------------------------------------------------------
Contact:
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