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Optimer Pharmaceuticals, Inc. Announces Presentation at ECCMID of Post-Hoc Subgroup Analysis of DIFICID in Adult Cancer Patients Being Treated for Clostridium difficile-Associated Diarrhea (CDAD)
Date:3/30/2012

erall safety profile was similar between the DIFICID and vancomycin treatment groups.

"CDAD is a common, but very serious complication for cancer patients and is a growing problem nationwide," said Roy F. Chemaly, M.D., M.P.H., F.A.C.P., F.I.D.S.A., associate professor and director of Infection Control in the Department of Infectious Diseases at The University of Texas MD Anderson Cancer Center in Houston, TX. "Because CDAD can have profound and disruptive effects in cancer patients, it is important that patients achieve both an initial cure and a sustained clinical response lasting beyond the initial treatment period."

Infections caused by C. difficile and the resulting CDAD pose a significant threat to cancer patients, primarily those with compromised immune systems due to chemotherapy or stem cell transplants. They also are at risk due to prolonged hospitalization and exposure to antibiotics. In fact, cancer patients with solid tumor or hematologic malignancies account for 16% of hospital CDAD cases.

"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 L. Gorbach, M.D., Chief Scientific Officer and Senior Vice President of Optimer Pharmaceuticals, Inc. "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." 

About the Study
The results are based on two randomized, double-blind, non-inferiority Phase 3 trials conducted at sites in North America and Europe. Subjects with confirmed CDAD received either 200 mg DIFICID (fidaxomicin) dosed orally twice daily or 125 mg vancomycin dosed orally four times daily for 10 days. The primary objective of the trials was to compare the safety and efficacy of a 10-day course of DIFICID versus a 10-day course of vancomycin for the treat
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SOURCE Optimer Pharmaceuticals, Inc.
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