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StaphVAX Confirmatory Phase III Trial Ahead of Schedule

ROCKVILLE, Md., Sept. 29 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals today announced the start of its confirmatory Phase III clinical trial with StaphVAX® (Staphylococcus aureus polysaccharide conjugate vaccine). The trial, being conducted with three leading dialysis providers will encompass approximately 3,000 end stage renal (kidney) disease (ESRD) patients on hemodialysis in approximately 200 sites across the United States.

"We are extremely pleased to start our StaphVAX confirmatory Phase III study ahead of schedule," said Henrik S. Rasmussen, senior vice president, clinical, medical and regulatory affairs. "There is a significant and growing need for new medical approaches to prevent the devastating consequences of Staph aureus infections. We believe that StaphVAX represents a potential solution to this problem. Our first Phase III study with StaphVAX, published last year in The New England Journal of Medicine demonstrated that StaphVAX significantly reduced the risk of developing blood stream infections in ESRD patients.

"With the FDA's agreement, the trial is designed with an eight-month efficacy endpoint as the primary endpoint, which was the peak efficacy point of the first trial. While there are no guarantees in biological drug development, we have done everything possible to maximize the likelihood of a favorable outcome in this clinical trial. We have increased the number of patients from 1800 to 3000 to increase the power of the study. We are studying the same patient population, that is end stage renal disease, and it is important to emphasize that treatment patterns and prognoses for these patients haven't changed since we completed the last trial."

Patients enrolled in the trial will be randomized to receive an intramuscular injection of StaphVAX or placebo upon entry into the study. All patients will be followed for a minimum of twelve months. The primary endpoint of the trial will be the incidence of blood stream infection (bacteremia) caused by types 5 and 8 Staph aureus through eight months post- vaccination. Because these patients are at chronic risk for Staph aureus infections, the trial will also include a booster vaccination at eight months. Secondary endpoints for this trial will include the incidence of Staph aureus bacteremia at 6, 10, 12, and 14 months as well as the cost of infections that occur during the study.

Patients with ESRD are at high-risk of developing Staph aureus bacteremia, partly because they are immune-compromised due to their debilitating underlying disease and also because the need for access to the vascular system for dialysis represents a point of entry of the S. aureus into the bloodstream. This patient population is projected to continue to grow due to the increasing number of patients suffering from the complications of diabetes which can often result in the loss of kidney function.

About Staph aureus Infections

Staph aureus is the most common cause of serious hospital-acquired infections, including bloodstream infections. Community-acquired staph infections are also of growing concern as they continue to increase in prevalence. Hospitals and other healthcare settings worldwide face unprecedented crises from the rapid emergence and dissemination of antibiotic- resistant bacteria, according to the National Institutes of Health and the Center for Disease Control. Strains of drug-resistant staph are found in most hospitals, often leaving vancomycin as the antibiotic of last resort for treating patients with these infections. With vancomycin-resistant strains of Staph aureus now appearing globally, many experts believe that a vaccine to prevent these infections may offer the best long-term solution.

According to the U.S. Centers for Disease Control and Prevention (CDC), more than two million patients in the U.S. each year contract an infection as a result of exposure while receiving healthcare in a hospital. Staph aureus is the most common single cause of these hospital-acquired infections and is reportedly associated with a death rate of 11 percent to 43 percent because of its capacity to cause serious complications and its resistance to most antibiotics. Staph aureus can spread from the blood (bacteremia), to the bones (osteomyelitis), or the inner lining of the heart and its valves (endocarditis), or cause abscesses in internal organs such as the lungs, liver and kidneys. People most at risk for these infections are surgical patients, trauma or burn victims, newborns whose immune systems are not yet developed, and patients with chronic illnesses such as diabetes, cancer, or lung or kidney diseases. People whose immune systems are suppressed due to disease, chemotherapy, or radiation therapy are generally more susceptible to these bacterial infections. ESRD patients on hemodialysis represent a particular high-risk group due to a combination of their compromised immune system and the need for repeated access to their blood system several times a week.

Source: Nabi Biopharmaceuticals

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