Nabi Biopharmaceuticals Takes Steps to Expand Market Potential for StaphVAX Beyond ESRD Patient Population


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

bacterial infections. 


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

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