The results showed that treatment with Copaxone reduced the risk of developing clinically definite multiple sclerosis (CDMS) by 44% versus placebo, and prolonged the quartile time to disease conversion to 722 days versus 336 days (+386 days, +115%) in those patients receiving placebo (hazard ratio 0.56, p=0.0005). At the time of the interim analysis, the proportion of patients who had developed CDMS was reduced from 43% in the placebo group to only 25% in the Copaxone group (p<0.0001). Based on these results, Teva plans to file a request for marketing authorization of Copaxone in Europe, the US and Canada for the treatment of patients with a first clinical event suggestive of MS. The multi-national, multi-center, prospective, double-blind, randomized, Phase III PreCISe study was conducted in approximately 100 centers located in the US, Europe, Argentina, Israel, Nordic countries, Australia and New Zealand and included a total of 481 patients presenting with a single clinical episode and MRI suggestive of MS. Patients included are those who had a unifocal disease manifestation (clinical evidence of a single lesion). Patients received either Copaxone 20mg/day or placebo as a subcutaneous injection and continued treatment for up to 36 months, unless a second attack was experienced and they were diagnosed with clinically definite MS. Patients who converted to CDMS continued the trial on active treatment for additional two years. The primary efficacy outcome was time to CDMS, based on a second clinical attack. The pre-planned interim analysis was performed on data accumulated from approximately 80% of the three-year placebo-controlled study exposure. Over the period up to the interim analysis, the proportion of patients developing CDMS was reduced from 43% in the placebo group to only 25% in the Copaxone group (p< 0.0001). Giancarlo Comi, principal investigator of the study, said: "These data on Copaxone demonstrated the importance of treating patients early on to provide rapid, early control of progression to CDMS, and stand to improve therapy options for the treatment of patients with first clinical event and a high risk to develop MS."