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Optimer Announces Presentation of Additional Data From Fidaxomicin Phase 3 Study for the Treatment of Clostridium Difficile Infection (CDI)
Date:9/15/2009

reated with fidaxomicin with only 3% and 9% recurrence rates respectively, versus 14% and 20% recurrence rates for vancomycin, respectively, at 10 and 20 days post-treatment.

In an oral presentation, Curtis J. Donskey, M.D., an investigator from the Cleveland VA Medical Center in Ohio, concluded that fidaxomicin is less likely than vancomycin to promote acquisition of VRE colonization in patients treated for CDI, likely due to inhibitory activity of fidaxomicin against many VRE strains and fidaxomicin's relative sparing of the intestinal flora including Bacteroides spp. The results showed that only 7% of patients treated with fidaxomicin acquired VRE versus 31% of vancomycin treated patients (p<0.001) from among a subset of 302 CDI patients, 248 of whom had a negative VRE stool sample upon entering the Phase 3 trial. In addition, 63% of the patients treated with fidaxomicin were found to retain greater than 100,000 Bacteroides bacteria per gram of stool versus only 13% of the vancomycin treated patients (p=0.004). These results provide further evidence that unlike vancomycin, fidaxomicin does not suppress Bacteroides bacteria, which is a major component of the intestinal flora and prevents C. difficile overgrowth. The Bacteroides sparing effect of fidaxomicin could be one of the reasons for the lower recurrence rate observed in the Phase 3 trial.

Detailed strain typing results from the phase 3 trial presented by Dale N. Gerding, M.D., from the Hines VA Hospital in Chicago, IL, identified the various strain type groups in the study. These data show that the overall cure rate among patients harboring BI isolates is significantly lower than those with non-BI strains (85.4% vs. 95.5% p=.004). Fidaxomicin and vancomycin had comparable cure rates against both BI and non-BI strains. The recurrence rates in the BI/NAP1/027 group, 36% of the patients analyzed, were similar between fidaxomicin and v
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SOURCE Optimer Pharmaceuticals, Inc.
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