Optimer Pharma (OPTR) Reports Superior Performance from DIFICID Phase 3 vs. Oral Vancomycin
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Optimer Pharmaceuticals, Inc. (Nasdaq: OPTR) announced the presentation of results from a post-hoc subgroup analysis of the company's two large Phase 3 trials which demonstrated that cancer patients with Clostridium difficile-associated diarrhea (CDAD) had higher clinical cure rates, better sustained response and lower recurrence when treated with DIFICID (fidaxomicin) tablets compared to oral vancomycin. The data will be presented at the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in London.
The analysis included 153 patients with active cancer who were treated in the two DIFICID Phase 3 studies and who received 8 days or more of treatment with DIFICID or oral vancomycin. In the overall combined population, patients with cancer had significantly lower cure and sustained response rates than patients without cancer. DIFICID was five times more likely than vancomycin to produce a clinical response and three times more likely to lead to a sustained response, while patients treated with vancomycin had a 2.6 fold greater risk of experiencing recurrence. Specifically, DIFICID provided superior response compared to vancomycin across all clinical endpoints studied: clinical response (97.3% vs. 87.5%, 95% CI 1.07-23.98; p=0.041), sustained response (83.6% vs. 61.3%, 95% CI 1.50-6.91; p=0.003) and disease recurrence (14.1% vs. 30.0%, 95% CI 0.16-0.89; p=0.025). Furthermore, cancer patients who were treated with DIFICID in the clinical studies had similar cure, recurrence and sustained response rates as non-cancer patients who received the drug, while cancer patients treated with vancomycin tended to have poorer outcomes than non-cancer patients. The overall safety profile was similar between the DIFICID and vancomycin treatment groups.
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The analysis included 153 patients with active cancer who were treated in the two DIFICID Phase 3 studies and who received 8 days or more of treatment with DIFICID or oral vancomycin. In the overall combined population, patients with cancer had significantly lower cure and sustained response rates than patients without cancer. DIFICID was five times more likely than vancomycin to produce a clinical response and three times more likely to lead to a sustained response, while patients treated with vancomycin had a 2.6 fold greater risk of experiencing recurrence. Specifically, DIFICID provided superior response compared to vancomycin across all clinical endpoints studied: clinical response (97.3% vs. 87.5%, 95% CI 1.07-23.98; p=0.041), sustained response (83.6% vs. 61.3%, 95% CI 1.50-6.91; p=0.003) and disease recurrence (14.1% vs. 30.0%, 95% CI 0.16-0.89; p=0.025). Furthermore, cancer patients who were treated with DIFICID in the clinical studies had similar cure, recurrence and sustained response rates as non-cancer patients who received the drug, while cancer patients treated with vancomycin tended to have poorer outcomes than non-cancer patients. The overall safety profile was similar between the DIFICID and vancomycin treatment groups.
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