EANS-News: SYGNIS Pharma AG
SYGNIS announces last patient treated in its AXIS
2 efficacy Study
03.11.2011 – 15:38
-------------------------------------------------------------------------------- Corporate news transmitted by euro adhoc. The issuer/originator is solely responsible for the content of this announcement. -------------------------------------------------------------------------------- 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 ### 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. ### Further inquiry note: Michael Wolf Telefon: +49 (6221) 454 - 6 E-Mail: Michael.Wolf@sygnis.de end of announcement euro adhoc -------------------------------------------------------------------------------- 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