Sanofi Pasteur Initiates Phase III Study of Investigational Clostridium difficile Vaccine in the United States
Cdiffense trial to evaluate vaccine against a leading cause of life-threatening, healthcare-associated infections worldwide
Swiftwater, PA – August 5, 2013 /PRNewswire/ — Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), announced today the initiation of its Phase III clinical program called Cdiffense to evaluate the safety, immunogenicity and efficacy of an investigational vaccine for the prevention of primary symptomatic Clostridium difficile infection (CDI). Clostridium difficile (C. diff) is a potentially life-threatening, spore-forming bacterium that causes intestinal disease. The risk of C. diff increases with age, antibiotic treatment and time spent in hospitals or nursing homes, where multiple cases can lead to outbreaks. The investigational vaccine is designed to help protect at-risk individuals from C. diff, which is emerging as a leading cause of life-threatening, healthcare-associated infections (HAIs) worldwide.1
C. diff toxins cause gastrointestinal disease that can lead to death in approximately eight to 15 percent of infected people,2 contributing to the approximately 14,000 C. diff-related fatalities in the United States (U.S.) each year.3 Since 20 to 30 percent of patients experience recurrences of CDI, re-hospitalizations and longer hospital stays remain common.4 In addition, CDI acute care costs U.S. healthcare systems approximately $4.8 billion annually.5 The investigational C. diff vaccine is designed to produce an immune response that targets the toxins generated by C. diff bacteria, which can cause inflammation of the gut and lead to diarrhea. It ultimately may help prevent a future infection from occurring.
“With the emergence of difficult-to-manage strains of C. diff, CDI has become more frequent, more severe and more difficult to treat in recent years, raising concerns about how to control it and prevent transmission,” explained John Shiver PhD, Senior Vice President for Research & Development at Sanofi Pasteur. “Vaccination could be an efficacious, cost-effective and important public-health measure to protect individuals from C. diff.”
The Cdiffense Phase III clinical program has just started recruiting volunteers at approximately 100 sites in the U.S. for a randomized, observer-blind, placebo-controlled, multi-center, multi-national trial that will include up to 15,000 adults across 17 countries. Volunteers for the study should be age 50 or older and planning an upcoming hospitalization or who have had at least two hospital stays and have received systemic antibiotics in the past year are also eligible. For more information on the Cdiffense trial, please visit www.Cdiffense.org
The U.S. Food and Drug Administration (FDA) granted fast-track designation to Sanofi Pasteur’s investigational C. diff vaccine candidate in 2010. The FDA’s fast-track program is designed to facilitate the development and expedite the review of new investigational 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. diff
Clostridium difficile (C. diff) is a potentially life-threatening, spore-forming bacterium that causes intestinal disease. According to the Centers for Disease Control and Prevention (CDC), approximately 500,000 Americans are infected with C. diff,6 and at least 14,000 fatalities are attributed to C. diff each year.3 The risk of contracting CDI increases with age, antibiotic treatment and time spent in hospitals or nursing homes, where multiple cases can lead to outbreaks.1 A main source of C. diff is infected patients who release spores into the environment that can then infect other people. When antibiotics disrupt the gut’s normal flora and a person has ingested C. diff spores, the C. diff bacteria multiply and release potent toxins that can damage a person’s intestinal lining and cause C. diff disease.7
Sanofi, an integrated global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients’ needs. Sanofi has core strengths in the field of healthcare with seven growth platforms: diabetes solutions, human vaccines, innovative drugs, consumer healthcare, emerging markets, animal health and the new Genzyme. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The company’s heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. For more information, please visit: www.sanofipasteur.com or www.sanofipasteur.us.
Forward Looking Statements
This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, the Group’s ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2012. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.
1 Centers for Disease Control and Prevention. Frequently Asked Questions about Clostridium difficile for Healthcare Providers. Centers for Disease Control and Prevention. http://www.cdc.gov/HAI/organisms/cdiff/Cdiff_faqs_HCP.html. Last Updated March 6, 2013. Accessed May 30, 2013.
2 Mitchell BG and Gardner A. (2012) Mortality and Clostridium difficile infection: a review. Aric journal.
3 Centers for Disease Control and Prevention. Clostridium difficile Infection. Centers for Disease Control and Prevention. http://www.cdc.gov/hai/organisms/cdiff/cdiff_infect.html. Last Updated March 1, 2013. Accessed May 30, 2013.
4 Garey KW, et al. (2008). Meta-analysis to assess risk factors for recurrent Clostridium difficile infection. Journal Hospital Infection, 70, p. 298-304.
5 Dubberke ER and Olsen MA. Burden of Clostridium Difficile on the Healthcare System. Clinical Infectious Diseases 55, no. suppl 2 (2012): S88–S92. doi:10.1093/cid/cis335.
6 Rohlke F and Stollman N. Fecal microbiota transplantation in relapsing Clostridium difficile infection. Therap Adv Gastroenterol. 2012 November; 5(6): 403–420. http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3491681/#bibr37-1756283X12453637. Accessed May 30, 2013.
7 Delmee M and Warny M. (1995). Clostridium difficile colitis: recent therapeutical and immunological considerations. Acta Gastroenterol Belg, 58 (3-4), p. 313-317.
Right-click the links below for ‘SAVE’ options
About Clostridium Difficile
Need for a C. diff Vaccine
C. diff Fact Sheet
C. diff Vaccine Fact Sheet
Cdiffense Phase III Trial Fact Sheet