EANS-Adhoc: SYGNIS Pharma AG
SYGNIS Pharma AG announces key results of its
Phase II trial of AX200 for the treatment of Acute Ischemic Stroke
15.12.2011 – 19:34
-------------------------------------------------------------------------------- ad-hoc disclosure pursuant to section 15 of the WpHG transmitted by euro adhoc with the aim of a Europe-wide distribution. The issuer is solely responsible for the content of this announcement. -------------------------------------------------------------------------------- Research & Development 15.12.2011 Ad-hoc release SYGNIS Pharma AG announces key results of its Phase II trial of AX200 for the treatment of Acute Ischemic Stroke Heidelberg, 15 December 2011 - SYGNIS Pharma AG (Frankfurt: LIOK; ISIN DE000A1E9B74; Prime Standard) today announces key results of the Phase II clinical trial (AXIS 2) of AX200 to treat acute ischemic stroke. The key results on the relevant primary endpoint, using the modified Rankin Scale (mRS), and secondary endpoint, using the National Institutes of Health Stroke Scale (NIHSS), show no improvement in patient outcome relative to the placebo- treated patient. As a result, the study missed its endpoints. The primary endpoint of significant functional improvement according to mRS evaluated AX200 treated patients relative to placebo-treated patients. The study recorded no clinical improvement and did not show any statistically significant difference. The secondary endpoint of improvement using the NIHSS relative to placebo-treated patients did also not record a clinically relevant or statistically significant difference. The randomized, double-blind AXIS 2 trial enrolled 328 patients in 78 centers throughout Europe. SYGNIS Pharma will continue to analyse the current data set and the new data that will become available in the weeks ahead. Full data will be available in Q1 2012. For further information please contact: |Dr. Franz-Werner Haas | |Senior VP Operations | |Tel: +49 (0) 6221-454 812 | |Email: franz-Werner.haas@sygnis.de | ### Disclaimer This publication is intended for information only and constitutes neither an offer to sell nor an invitation to buy securities. 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: |Dr. Franz-Werner Haas | Senior VP Operations Tel: +49 (0) 6221-454 812 Email: franz-Werner.haas@sygnis.de end of announcement euro adhoc -------------------------------------------------------------------------------- issuer: 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