SYGNIS Pharma AG, has announced that the independent Data Safety Monitoring Board (DSMB), which is responsible for monitoring safety issues with regard to the execution of the Phase II efficacy study of AX200 for the treatment of acute ischemic Stroke (AXIS 2), has held its final interim review before the end of the trial and recommended its unmodified continuation.
Based on the data of 75% of the 328 AXIS 2-patients the DSMB held its third interim review. As the accessible study-data continues to show the administration of AX200 is safe and well tolerated by the patients, the DSMB confirmed its recommendation of December 2010 when of 50% of all AXIS 2-patients were recruited.
Dr Frank Rathgeb, Chief Medical Officer of SYGNIS, said: "The patient recruitment for AXIS 2 has improved significantly in recent months and the data continues to show AX200 has a good safety profile. Therefore, we should be in a good position to report the top-line data in the second half of 2011."