John E. Ervin, M.D. Participates in a Phase II Vaccine Trial for Primary Prevention of Clostridium difficile

FOR IMMEDIATE RELEASE
Kansas City, Kansas, United States of America (Free-Press-Release.com) December 1, 2011 -- Kansas City, MO – December 1, 2011 – John E. Ervin, M.D., Medical Director at The Center for Pharmaceutical Research, announced today that it is participating in a phase II clinical study of an investigational vaccine for primary prevention of Clostridium difficile infection (CDI). The trial being held across the United States is focused on evaluating prevention of the first episode of CDI in at-risk individuals, which includes adults with imminent hospitalization or current or impending residence in a long-term care or rehabilitation facility.

The incidence of CDI has increased significantly in recent years in both North America and Europe. CDI-related treatments in these two regions of the world are estimated to be costing more than $7 billion a year. The recent emergence and spread of a hyper-virulent strain of C. difficile further highlights the importance of preventing CDI.

C. difficile is present worldwide and has become the most frequent hospital-acquired infection in the U.S., Europe, and Canada. Standard treatment of C. difficile infection involves the use of antibiotics. The trial in which John E. Ervin, M.D. is participating includes an investigational CDI preventative vaccine being developed by Sanofi Pasteur.

“This investigational vaccine has already completed phase I clinical trials in more than 200 participants to evaluate its safety and immunogenicity,” explained Dr. Ervin.

The U.S. Food and Drug Administration (FDA) recently granted fast-track designation to Sanofi Pasteur’s investigational Clostridium difficile vaccine candidate. The fast-track program of the FDA is designed to facilitate the development and expedite the review of new drugs and vaccines that are intended to treat or prevent serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.

About C. difficile

C. difficile is an anaerobic spore-forming bacterium, present asymptomatically in approximately 60 percent of infants and approximately three percent of healthy adults. It belongs to the Clostridium family of bacteria, which also includes C. tetani (tetanus) and C. botulinum (botulism). The C. difficile bacteria produce two potent toxins: A and B. When the natural microbial flora of the gut is disturbed, usually as a result of antibiotic treatment for other illnesses, and a patient is exposed to C. difficile spores, the bacteria can multiply and release the two toxins, which cause a broad range of gastrointestinal symptoms in humans known collectively as CDI.

Hospital-acquired infections caused by C. difficile are a considerable problem in many industrialized countries, including the U.S., Canada, and Europe. It is estimated that there are about 500,000 cases of CDI in the US alone1, with annual costs to the healthcare system of $3.2 billion2. In the EU, assuming a population of about 460 million people, the healthcare costs of CDI are estimated to be around $4.4 billion per year.3 Additional information is available at the US Centers for Disease Control and Prevention and UK Health Protection Agency C. difficile information pages1,4.

About John E. Ervin, M.D.

Dr. John E. Ervin earned his undergraduate degree at the University of Notre Dame and received his medical degree from the University of Kansas School of Medicine in 1976. There he completed a Residency in Internal Medicine and a Fellowship in Allergy, Immunology, and Rheumatology. He is board-certified in both Internal Medicine and Rheumatology. In addition, Dr. Ervin has been on the teaching staff at both the University of Kansas Medical Center and the University of Missouri Kansas City (UMKC). Dr. Ervin has practiced medicine for 35 years and is the Founder and Medical Director of The Center for Pharmaceutical Research.

About The Center for Pharmaceutical Research

The Center for Pharmaceutical Research (CPR) is a privately owned clinical research center in Kansas City, MO specializing in Phase II, IIb, IIIb, and IV clinical trials for the pharmaceutical, nutraceutical, and medical device industries. John E. Ervin, M.D., F.A.C.P., F.A.C.R. founded The Center for Pharmaceutical Research in 1986 and serves as the President, Medical Director, and Principal Investigator. Since its inception, CPR has conducted more than 500 trials in most areas of medical and surgical subspecialties. CPR works towards advancing medicine by conducting clinical research studies with the help of members of the community and by providing ethical, safe, closely supervised and cutting-edge medical care for volunteers. CPR is nationally recognized by the Pharma industry as one of the premier sites conducting clinical research in the country. It is located in south Kansas City on the campus of St. Joseph Medical Center.

Contact
Missy MacPhail
VP Business Development
816-943-0770
pr@cprkc.com
www.cprkc.com

References:
1. CDC: www.cdc.gov/ncidod/dhqp/id_Cdiff.html
2. O’Brien et al, The Emerging Infectious Challenge of Clostridium difficile-Associated Disease in Massachusetts Hospitals: Clinical and Economic Consequences. Infection Control and Hospital Epidemiology, 2007; 28(11):1219-1227

3. European Centre for Disease Prevention and Control, Emergence of Clostridium difficile-associated disease in North America and Europe, Clinical Microbiology and Infectious Diseases, 2006; 12 (Suppl. 6): 2–18
4. HPA: www.hpa.nhs.uk/webw/HPAweb&Page&HPAwebAutoListName/Page/1179744911867

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