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New data show the benefits of Dificlir in cancer patients at high risk of CDI
8-April-2012: New data show that among cancer patients with ICD, Dificlir (fidaxomicine) may offer significant advantages in terms of clinical cure of recurrence and prolonged clinical recovery. The data was presented at the 22nd European Congress of Clinical Microbiology and Infectious Diseases (ECCMID).
The data presented are from two phase III clinical trials. A retrospective analysis was conducted to compare the outcome of patients according to whether they were carriers of a cancer diagnosis. During clinical trials, data on cancer diagnosis were not collected as a predefined criterion.
The DCI, a leading cause of nosocomial diarrhoea in adults, has become a growing problem in hospitals, nursing homes and other centres of long-term care. The risk of DCI increases with duration of hospitalization, Patients treated with chemotherapy and those with solid tumors may be particularly sensitive to the ICD because of their long hospital stays and exposure to many antibiotics and chemotherapeutic agents.
"The cancer patients are a vulnerable population at high risk of DCI, due to the weakening of their immune system frequently. The ICD can have disastrous effects in patients already weakened by the fight against disease. Treatment options that reduce the weight of the ICD and recidivism in particular, will enable clinicians to focus on cancer treatment," said Professor Oliver Cornely, Medical Director of the Centre for Clinical Trials University of Cologne in Germany, and principal investigator of the study.
In two phase III clinical trials, 1105 patients with ICD were included in a population known as "modified intent to treat" (mITT), in which 183 patients (16.6%) were already carrying diagnosed with cancer. The retrospective analysis of this subgroup of cancer patients shows that the ICD leads to a lower rate of clinical cure and prolonged episodes of diarrhoea. Compared to patients treated with vancomycin, Dificlir those treated had a higher rate of cure (97.3% against 87.5%) and prolonged clinical recovery (83.6% against 61.3%), as well as a reduced rate of recurrence (14.1% against 30.0%) in this population.
Additional data announced at the ECCMID Congress and published this month in the Lancet Infectious Diseases Dificlir confirm data showing that DIFI Dificlir an efficacy and a safety profile similar to oral vancomycin and also offers the advantage of an excellent long-term response and a greater reduction in relapse rate.
The results of the clinical trial phase III study of 509 adults in Europe and North America with a diagnosis of ICD have shown that patients treated with Dificlir had a significantly lower rate of recurrent ICD (12.7%) than those treated with vancomycin. In addition, patients who received Dificlir were more likely than those treated with vancomycin to achieve sustained clinical cure.
"The results of phase III pivotal trials and retrospective analyzes have shown the effectiveness of Dificlir as new and effective treatment in patients with ICD, but also in high risk populations, such as cancer patients," said Ken Jones, president and CEO of Astellas Pharma Europe Ltd. "Astellas is committed to developing effective treatments for patients in areas where there is a clear unmet medical need."
Dificlir, known as the Dificid United States, was discovered and developed by Optimer Pharmaceuticals, Inc.. This antibiotic has been approved by the Food and Drug Administration of the United States in May 2011 and has received authorization in the European market in December 2011 for the treatment of adults with DCI, also known as behalf of Clostridium difficile associated diarrhea.
Astellas Pharma Europe Ltd. holds the exclusive license for the development and commercialization of Dificlir in Europe and other countries in the Middle East, Africa and the Commonwealth of Independent States.
Astellas Pharma Europe Ltd. is a European subsidiary of Astellas Pharma Inc. company, is a pharmaceutical company dedicated to improving the health of the world by providing innovative and reliable pharmaceutical products.