Positive data from subgroup analysis presented at 19th annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) meeting in Helsinki, Finland
SAN DIEGO, May 17 /PRNewswire-FirstCall/ -- Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) announced that the results from its North American Phase 3 clinical study of fidaxomicin in patients with Clostridium difficile infection (CDI) were presented today by clinical investigator Thomas J. Louie, M.D. for the first time in an oral presentation at the 19th annual European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Helsinki, Finland.
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Dr. Louie presented the positive top-line results that the Company had previously announced in November 2008. The trial met its primary endpoint with fidaxomicin achieving clinical cure compared to Vancocin(R). In addition, patients treated with fidaxomicin experienced a reduction in CDI recurrence compared to Vancocin (p=0.004) and had a higher global cure (cure with no recurrence within four weeks) compared to Vancocin (p=0.006).
'This study showed that fidaxomicin is as effective as vancomycin for treatment of C. Difficile diarrhea, including treatment of infection by the hyper virulent NAP1/ribotype 027 outbreak strain. Moreover, compared to vancomycin, recurrence of CDI is significantly less likely to occur following fidaxomicin therapy. Combining cure of CDI and freedom from recurrence, fidaxomicin is superior to vancomycin as treatment for this serious and common cause of infectious diarrhea,' said Thomas J. Louie, M.D., Medical Director, Infection Prevention and Control for the Calgary Health Region and professor in the Departments of Medicine and Microbiology-Infectious Diseases, University of Calgary. 'These findings indicate that fidaxomicin offers both highly effective but more selective therapy that is less damaging to the normal intestinal bacteria that protect against recurrence of CDI.'
Additional findings also presented for the first time include a subgroup analysis of clinical cure and recurrence rates for fidaxomicin compared to Vancocin, as well as baseline demographic and disease characteristics. Clinical cure rates for fidaxomicin and Vancocin were similar in each of the following subgroups: patient status (in-patient/out-patient), age (under/over 65) and strain type (BI/NAP1/027). Most notably, fidaxomicin showed a reduction across several subgroups in recurrence rates compared to Vancocin in both out-patient and in-patient settings, as well as in patients both over and under the age of 65. The recurrence rates in the BI/NAP1/027 subgroup were similar between fidaxomicin and Vancocin.
