EANS-News: SYGNIS Pharma AG
SYGNIS successfully completes patient recruitment
for AXIS 2 Study
09.08.2011 – 06:47
-------------------------------------------------------------------------------- Corporate news transmitted by euro adhoc. The issuer/originator is solely responsible for the content of this announcement. -------------------------------------------------------------------------------- Research & Development Heidelberg (euro adhoc) - SYGNIS successfully completes patient recruitment for AXIS 2 Study 328 patients recruited at about 80 stroke centres in eight European countries AX200 is one of the most advanced drug candidates worldwide for the treatment of stroke Initial results of the AXIS 2 Study are expected towards the end of 2011 Heidelberg, 9 August 2011 - SYGNIS Pharma AG (Frankfurt: LIOK; ISIN DE000A1E9B74; Prime Standard), a clinical stage biotech company researching and developing innovative CNS treatments, announced the successful completion of the patient recruitment for its AXIS 2 Study. This randomized, double-blind study is designed to demonstrate the efficacy of AX200 (G-CSF) for the treatment of patients with acute ischemic stroke. Dr. Frank Rathgeb, Chief Medical Officer of SYGNIS, said: "With the completion of patient enrolment we have reached the next milestone of the clinical development of AX200 for the treatment of acute stroke: After the completion of a three month monitoring period of this last patient, we will enter the crucial evaluation phase during which we will analyse all collected data and, as a result, gain clarity on the potential of AX200 for the treatment of acute stroke. We expect to report initial meaningful findings of the AXIS 2 Study towards the end of 2011". Prof. Ringelstein, Director of Clinic and Policlinic for Neurology of the University of Münster, commented: " AX200 provides a very promising approach in the field of the acute medical treatment of stroke, for which there are currently only few and time-limited therapeutic options available. In the Steering Committee we have ensured that the specific challenges of this indication as well as the latest scientific findings are reflected in the design of the AXIS 2 Study accordingly and that the execution of the Study at the renowned stroke-centres across Europe meets the highest standards of quality. Accordingly, our expectations with regard to the results of the AXIS 2 Study are high." After the completion of a subsequent three month observation period for the last patient recruited, the data collection will be finalized. The data will be prepared (data-cleaning) and evaluated. Based on these findings, SYGNIS will evaluate the options for the further development or commercialization of AX200. In this regard SYGNIS might start an additional clinical study, aimed to confirm the efficacy of AX200 for the treatment of acute stroke, by itself or together with an appropriate pharma partner or out-license the entire AX200 project. SYGNIS is adequately equipped with financial resources. Taken into account that the Company will receive at least 6 million Euros as a result of the capital increase, initiated in July 2011, SYGNIS is therefore financed until the end of calendar year 2012. 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 have 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 Philips 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. ### 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