In May 2009 SYGNIS has initiated a multinational phase II efficacy trial of its lead compound, AX200, for the treatment of acute ischemic stroke (AXIS 2), the patient recruitment of which was successfully completed in August 2011. First substantial results of the AXIS 2 Study are expected to be available by the end of calendar year 2011.
The randomized, double-blind trial was executed 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.
The goal of AXIS 2 is to assess the efficacy of AX200 compared to placebo in patients suffering from acute ischemic stroke. The primary endpoint of the AXIS 2 Study is the clinical patient outcome evaluated by using the modified Rankin Scale (mRS) which is the commonly accepted standard clinical scale for measuring global functioning of stroke patients. Secondary endpoints include further clinical scales for functional ability on one hand, and safety as well as imaging technology to assess changes in infarct size on the other hand.
After the completion of a subsequent three month observation period for the last patient recruited, the data collection will be finalized. Thereafter, the data will be prepared (data-cleaning) and evaluated. Based on these findings, SYGNIS will evaluate its options for the further development or commercialization of AX200.
Further information on the clinical trial can be obtained at http://clinicaltrials.gov/ct2/show/NCT00927836.