EANS-News: SYGNIS Pharma AG
SYGNIS announces Data Safety Monitoring Board
Recommendation for Phase II efficacy study for AX200
Heidelberg (euro adhoc) -
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Research & Development
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 2011Heidelberg, 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
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
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