New Data Demonstrates DIFICLIR™ May Offer Benefits for Cancer Patients, who are at High Risk of Clostridium Difficile …

STAINES, UK, March 31, 2012 /PRNewswire/ --

Clostridium difficile infection (CDI), a potentially fatal disease, is one of the most common healthcare acquired infections inEurope[1]

New data presented at the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) demonstrate that in cancer patients with CDI, DIFICLIR(fidaxomicin) may offer significant benefits in terms of clinical cure*, recurrence[#] and sustained clinical cure[=].[2]

The data presented were derived from two Phase III clinical trials. A post hoc analysis compared outcomes in patients who had a diagnosis of cancer with outcomes for patients who did not. In the clinical trials, the data on cancer diagnosis was not collected as a pre-defined endpoint.

CDI is the leading cause of healthcare-acquired diarrhoea in adults[1] and has become an increasing problem in hospitals, nursing homes and other long-term care facilities.[3] A person's risk of CDI increases with a longer period of hospitalisation.[4] Patients who have received chemotherapy and those with solid tumours can be particularly susceptible to CDI due to their long hospital stays and exposure to many antibiotics and chemotherapeutic agents.[5]

"Patients with cancer represent a vulnerable population who are at high risk of CDI, often resulting from their compromised immune system. CDI can be a devastating addition for patients who are already battling pre-existing conditions. Treatment options that reduce the burden of CDI and in particular recurrence, will allow clinicians to focus their efforts on treating the cancer." said Professor Oliver Cornely, Medical Director of the Clinical Trial Center of The University of Cologne, Germany and lead investigator of the study.

In two Phase III clinical trials, there were 1105 patients with CDI in the total modified-intent-to-treat (mITT) population, of which 183 (16.6%) patients had a current diagnosis of cancer. A post-hoc analysis of the data from this sub-group of cancer patients shows that CDI results in a lower clinical cure rate and prolonged episodes of diarrhoea.[2] When compared to patients treated with vancomycin, those treated with DIFICLIR had higher clinical cure (97.3% vs. 87.5%) and sustained clinical cure (83.6% vs. 61.3%), as well as reduced rates of recurrence (14.1% vs. 30.0%) in this population.[2]

Further data announced at ECCMID, and published this month in the Lancet Infectious Diseases supports existing DIFICLIR data by demonstrating that DIFICLIR has a similar efficacy and tolerability profile to oral vancomycin and also offers the benefit of a superior sustained response and a greater reduction in rates of recurrence.[6]

Results from the Phase III clinical trial (Study OPT-80-004) of 509 adults across Europe and North America with a diagnosis of CDI showed that patients treated with DIFICLIR had a significantly lower rate of CDI recurrence (12.7%) compared with those receiving vancomycin (26.9%, p<0.001). In addition, DIFICLIR recipients were more likely than those treated with vancomycin to achieve sustained clinical cure (76.6% vs. 63.4% respectively, p=0.001).[6]

"Results from key Phase III trials and the post-hoc analysis demonstrate the effectiveness of DIFICLIR as a novel and effective treatment in patients with CDI, but also in high risk populations, such as patients with cancer," said Ken Jones, President and CEO of Astellas Pharma Europe Ltd. "Astellas are committed to developing effective treatments for patients where there is a clear unmet medical need."

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New Data Demonstrates DIFICLIR™ May Offer Benefits for Cancer Patients, who are at High Risk of Clostridium Difficile ...