EXTON, Pa., Oct. 17 /PRNewswire-FirstCall/ -- ViroPharma Incorporated today announced the launch of several new health initiatives to combat the Clostridium difficile-associated disease (CDAD), an epidemic that has now spread to over 20 states. The epidemic continues to claim many lives and has attracted significant attention from the Centers for Disease Control and Prevention (CDC), The National Institute for Health, and professional medical societies such as the Infectious Disease Society of America. Most of the concern has centered on the spread of a new “hyper-virulent” strain of the bacteria that is largely resistant to a common antibiotic group known as ‘fluoroquinolones’ and produces up to 24 times the amount of C. difficile toxin as previously identified strains. Infection with this strain can lead to severe disease that rapidly progresses, and can result in death within days of disease presentation.
CDAD historically has affected primarily elderly patients who are frequently hospitalized and often administered broad spectrum antibiotics. These antibiotics can kill off so-called “good bacteria” that naturally reside in the gastrointestinal tract and keep “bad bugs” in check. Once these good bacteria are gone, patients are at risk of acquiring a common, dangerous, and highly infectious nosocomial infection caused by a bacterium called C. difficile. These bacteria form highly durable and infectious spores which may contaminate patients’ skin and environmental surfaces. These infectious spores are then easily transmitted from patient to patient on healthcare workers’ hands, or by contacting contaminated surfaces.
According the CDC, over the past two years, several states have reported increased rates of CDAD, noting more severe disease and an associated increase in morbidity and mortality. Overall C. difficile disease rates in U.S. acute care hospitals have more than doubled since 2000.
“The Clostridium difficile organism is a difficult bacteria to culture and type, and the disease it causes is even more difficult to manage; once an institution starts to see an outbreak of infection spread through their patients, it is very difficult to eradicate - the best one can hope for are more effective measures to help control the rate of infection,” commented Dale Gerding, M.D., associate chief of staff for research at the Hines VA Hospital. “Today’s disease is simply different than in the past. Far more patients are getting extremely sick, many of whom would have in the past been at little to no risk of disease. There are more cases of severe, life-threatening disease today than ever before, especially in the very elderly patients. There is a great need for additional data on the epidemiology of CDAD, the characteristics of the epidemic organisms, and on the patients suffering from this disease. What we can learn today will help to improve surveillance, increase outbreak control and prevention, and establish safe and effective treatments for these patients.”
ViroPharma is pleased to work with leading physicians towards several investigator-lead trials, including:
-- Identifying the epidemic strain -- Culture, Typing, PCR and Susceptibility of Clostridium difficile from Clinical Specimens: Current methods of detecting and diagnosing CDAD usually do not enable the identification of the hyper-virulent, epidemic strain of C. difficile. As a result, health care providers may not be aggressive enough in implementing control measures to control the spread of this deadly strain. To provide a better understanding of C. difficile epidemiology, molecular microbiology, and susceptibility to various drugs, the Hines VA Hospital has established a Microbiology Reference Laboratory (MRL), which will aid institutions in typing strains of the bacterium and perform susceptibility testing of C. difficile in an effort to improve detection and management strategies for dealing with the epidemic strain. -- Adding data on infection control -- Shedding of Clostridium difficile and other nosocomial pathogens during and after treatment of C. difficile-associated diarrhea with vancomycin versus metronidazole: During the course of CDAD, infectious spores are easily passed from patient to patient on physician hands and hospital surfaces. Hospitalized patients with CDAD may frequently have concomitant intestinal colonization with pathogens including vancomycin-resistant enterococci (VRE) and methicillin-resistant Staphylococcus aureus (MRSA) that can also be shed onto skin and environmental surfaces. This study will examine the hypothesis that treatment of CDAD with oral vancomycin may be associated with decreased shedding of C. difficile spores in comparison to treatment with metronidazole, and improved inhibition of coexisting S. aureus colonization. These data will help elucidate how C. difficile is shed into the environment, and improve C. difficile, VRE and MRSA infection control methods. -- How does CDAD affect the gastrointestinal tract? -- Exploratory Study of the Gastrointestinal Environment in Patients with Clostridium difficile-Associated Disease (CDAD): The physiology of the gastrointestinal tract of a patient with CDAD is complex and not well described. Factors which may influence performance and contribute to the effective and consistent delivery of effective therapy - including core body temperature, changes in pH over the length of the gastrointestinal tract, and gastrointestinal motility or flow volumes - need to be studied. The purpose of this study is to examine the intestinal environment of patients with CDAD and compare the findings to a population of healthy subjects. This study will utilize a “SmartPill(R) GI Monitoring System” which measures gastrointestinal pH and transit times. The data derived from this study will provide a new basis of understanding the environment of the gastrointestinal tract of patients with CDAD, and provide new data to better understand the potential relevance for dissolution and solubility of anti-infective therapy in these patients. -- Other related gastrointestinal disorders -- A Pilot Trial of Oral Vancocin(R) in Primary Sclerosing Cholangitis: Primary sclerosing cholangitis, or PSC (also known as “Walter Payton Disease”), is a disease primarily of the bile ducts, both inside and outside the liver. As disease progresses, the walls of the bile ducts become inflamed which causes scarring and hardening that narrows and largely blocks the bile ducts. Because bile cannot drain properly through the ducts, it accumulates in the liver causing damage to the organ. With long-term cell damage, the liver can develop cirrhosis and may no longer function properly. PSC also appears to be associated with ulcerative colitis, a type of inflammatory bowel disease. While researchers do not know what causes PSC, among the theories under investigation is the possible role of bacterial flora and how modification by Vancocin might influence this disease.
“It is especially important today to dedicate efforts toward better understanding CDAD, how it is spread, and the patients themselves who are at risk of CDAD and other clinical manifestations of the disease,” stated Michel de Rosen, ViroPharma’s president and chief executive officer. “As a leader in the development of treatments for CDAD, it is our responsibility to take the additional steps needed to better understand this new epidemic and provide education to medical professionals who are responsible for diagnosing and treating affected patients. Through these valuable programs, many of which have been in the planning phases for some time, ViroPharma is continuing to do its part in the healthcare community to address the spread of this life- threatening disease.”
About Clostridium difficile
C. difficile is a bacterium, which under certain circumstances, typically after antibiotic therapy, can colonize the lower gastrointestinal tract where it may produce toxins which cause inflammation of the colon and diarrhea, and the associated complications of disease, including death. Advanced age, gastrointestinal surgery/manipulation, long length of stay in healthcare settings, a serious underlying illness and compromised immunity are conditions associated with increased risk of disease. According to the CDC, there are approximately 3,000,000 cases of antibiotic-associated diarrhea per year; 15 to 25 percent are caused by C. difficile.
About ViroPharma Incorporated
ViroPharma Incorporated is a biopharmaceutical company dedicated to the development and commercialization of products that address serious diseases treated by physician specialists and in hospital settings. ViroPharma commercializes Vancocin(R), approved for oral administration for treatment of antibiotic-associated pseudomembranous colitis caused by Clostridium difficile and enterocolitis caused by Staphylococcus aureus, including methicillin- resistant strains (for prescribing information, please download the package insert at http://www.viropharma.com/docs/pulvules_pi.pdf). ViroPharma currently focuses its drug development activities in viral diseases including cytomegalovirus (CMV) and hepatitis C (HCV). For more information on ViroPharma, visit the company’s website at http://www.viropharma.com.
Certain statements in this press release may contain forward-looking statements that involve a number of risks and uncertainties. Our actual results could differ materially from those results expressed in, or implied by, these forward-looking statements. These factors, and other factors, including, but not limited to those described in ViroPharma’s annual report on Form 10-Q for the quarter ended June 30, 2006 filed with the Securities and Exchange Commission could cause future results to differ materially from the expectations expressed in this press release. The forward-looking statements contained in this press release may become outdated over time. ViroPharma does not assume any responsibility for updating any forward-looking statements.
SmartPill(R) is a registered trademark of The SmartPill Corporation.
ViroPharma Incorporated
CONTACT: William C. Roberts, Director, Corporate Communications,+1-610-321-6288, or Robert A. Doody Jr., Manager, Corporate Communications,+1-610-321-6290, both of ViroPharma Incorporated
Web site: http://www.viropharma.com/
