Optimer Pharmaceuticals, Inc. (OPTR) said Friday that results from a post-hoc subgroup analysis of the company's two large Phase 3 trials showed cancer patients with Clostridium difficile-associated diarrhea had higher clinical cure rates, better sustained response and lower recurrence when treated with DIFICID tablets compared to oral vancomycin.
The data will be presented at the 22nd European Congress of Clinical Microbiology and Infectious Diseases 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. Infections caused by C. difficile and the resulting diarrhea pose a significant threat to cancer patients, mainly those with compromised immune systems due to chemotherapy or stem cell transplants.
"The results from this analysis reinforce the important role of DIFICID in the treatment of CDAD, especially its use as a front-line agent," said Sherwood Gorbach, Chief Scientific Officer and Senior Vice President of Optimer. "We are encouraged by these results and look forward to conducting future clinical trials to explore the potential benefits of DIFICID in patients with cancer and others who are at high risk for CDAD."
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