SYGNIS successfully completes patient recruitment for AXIS 2 Study

328 patients recruited at about 80 stroke centres in eight European countries

10-Aug-2011 - Germany

SYGNIS Pharma AG 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.

https://www.bionity.com/en/news/133905/sygnis-successfully-completes-patient-recruitment-for-axis-2-study.html