BOCA RATON, Fla. Nabi Biopharmaceuticals announces that it has initiated the
first in a series of additional clinical studies for StaphVAX
(Staphylococcus aureus Polysaccharide Conjugate Vaccine), its investigational
vaccine designed to prevent the most prevalent strains of Staphylococcus aureus
The target groups for these studies will be cardiovascular and orthopedic surgery patients in the United States and Europe. The goal is to provide evidence that a vaccine against Staph aureus bacterial infections can raise high levels of antibodies capable of providing
protection in patients at-risk for these infections. Patients are put at-risk
for developing staph infections as a complication of being hospitalized or
treated in nursing homes or in dialysis centers. Staph aureus bacteria are
the most common cause of hospital-acquired infections and are becoming
increasingly resistant to available antibiotics.
StaphVAX is currently in a Phase III efficacy trial designed to confirm
that the product can prevent Staph aureus infections in end-stage renal
disease (ESRD) patients. Patients with ESRD are at high-risk of
developing S. aureus bacteremia and are among the most difficult patients to
treat because they are immune-compromised due to their debilitating,
underlying disease and because dialysis access provides an opportunity for
bacteria to be introduced into their bloodstream.
"The significance of this new study is to provide evidence that antibody
levels in a broader at-risk patient population reach a level of protection
comparable to the protective levels achieved in ESRD patients, thereby
broadening the patient population who could benefit from receiving StaphVAX,"
stated Henrik S. Rasmussen, MD, PhD, senior vice president of clinical,
medical and regulatory affairs for Nabi Biopharmaceuticals.
Rasmussen continued, "We expect to conduct a series of studies in both the United States
and Europe over the next two years. To better understand the complications of
infection in these broader, at-risk patient groups, we also expect later this
year to announce results of a pharmacoeconomic study being conducted at Duke
University focused on the cost and rates of incidence relative to staph
infections in cardiac and orthopedic surgery patients."
Rasmussen concluded, "The incidence of hospital-acquired Staph aureus
infections is growing at an alarming rate due to three primary factors -- the
aging of the population, increased use of immuno-suppressive drugs and
increased implantation of synthetic devices, such as a heart value or knee
replacement. To add to this problem, Staph aureus infections are highly
resistant to available antibiotics, with increasing resistance to vancomycin,
which until now has been the treatment of last resort. In the United States
alone, over 12 million patients are at-risk for developing Staph aureus
infections each year, including patients undergoing treatment with cancer
chemotherapy, and orthopedic and cardiac surgery patients."
The Phase IIb immunogenicity study will include a total of 200 patients in
approximately 10 of the leading cardiothoracic centers in the United States.
The study is designed to evaluate safety and antibody levels over a six-month
period, and to provide evidence that broader, at-risk patient groups can
achieve antibody levels equal to or greater than the levels proven to be
protective in immune-compromised ESRD patients.
Thomas H. McLain, chairman, CEO and president of Nabi Biopharmaceuticals,
stated, "The results of the study will not only be important in generating
clinical data to support Nabi's 2005 Biologic License Application filing in
the United States and a supplement to our European Marketing Authorization
Application, but these studies will also build awareness of StaphVAX among key
physicians and thought leaders in other treatment areas."
McLain continued, "Today, in an effort to prevent infection, antibiotics are often used in surgery and other at-risk patients to prevent staph infections. The Centers for Disease Control (CDC)has cited the overuse of antibiotics as a significant factor in the increasing incidence of antibiotic resistance. In response, both the CDC and the World
Health Organization have recommended that the development of a vaccine to
prevent these infections should be given a very high priority."
McLain concluded, "Our approach with StaphVAX supports that important
goal. Further, as we begin to demonstrate the potential of StaphVAX to
prevent infection in other patient populations, we believe this approach can
be synergistic with new antibiotic therapies. By providing an effective
alternative to using antibiotics to prevent infections and thereby reducing
the overuse of antibiotics, we may be able to help slow the development of
antibiotic resistance and permit next generation antibiotics to be reserved
for those patients who develop a staph infection."
Staph aureus is the most common cause of serious hospital-acquired
bloodstream infections. Staphylococcal infections are difficult to treat
because the bacteria that cause them are highly virulent and, in many cases,
resistant to currently available antibiotics. This rise of antibiotic
resistance has markedly curtailed options for treating Staph aureus
infections. According to the current estimates by the CDC, more than 2 million patients in the United States each year contract an infection as a result of exposure to a
pathogen while receiving care in a hospital. 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.
Source: Nabi Biopharmaceuticals