Independent data review supports continuation of phase III programme with intravenous iclaprim
Arpida Ltd announced that it has received the recommendation from an independent Data and Safety Monitoring Board (DSMB) to continue the Phase III clinical trials for intravenous iclaprim for the indication complicated Skin and Skin Structure Infections (cSSSI). The DSMB made its recommendation after a planned review of clinical data from the ongoing ASSIST-1 (Arpida s Skin and skin Structure Infection STudies) trial. The DSMB reviewed data on approximately 40% of the total number of patients to be enrolled into ASSIST-1, the first of the two ASSIST trials, and concluded that there are no safety concerns that would justify changes to be made to the clinical study design for either trial.
The results are blinded to Arpida and will remain so until the trial is fully completed. The global Phase III ASSIST trials are designed to compare the efficacy and safety of iclaprim with that of market leader linezolid (marketed by Pfizer as Zyvox®). Both ASSIST-1 and ASSIST-2 are global, multicenter trials conducted in various countries in North America, Europe and the rest of the world. Arpida expects to complete ASSIST-1 before the end of 2006.
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