Nabi Biopharmaceuticals Initiates Phase I Study of Staphylococcus aureus Type 336 Vaccine

BOCA RATON, Fla. Nabi Biopharmaceuticals announced today the initiation of the first human clinical study for its vaccine being developed to prevent Staphylococcus aureus type 336 infections in at-risk patients.  Patients at the highest risk for S. aureus infections include dialysis patients, patients undergoing certain types of invasive surgery, patients in intensive care or shock-trauma units, patients receiving cancer chemotherapy or other immune suppressive treatments, and patients in long-term care facilities.  This is a Phase I study that will evaluate safety and immune response of the vaccine in healthy

volunteers.

   

While there are numerous species of Staphylococci, three species are

responsible for almost all S. aureus infections.  S. aureus types 5 and 8

account for approximately 80-85 percent of all Gram-positive hospital-acquired

infections, with type 336 accounting for the other 15 percent to 20 percent.  Type 336,

like other S. aureus bacteria, often lives transiently or permanently in the

nasal passages or on the skin of humans.  It is estimated that approximately

20-30 percent of the adult population at any given time is colonized with one

of the three serotypes of S. aureus.

  

"Hospital-acquired S. aureus infections, including type 336, pose a

rapidly growing challenge for healthcare globally," said Thomas H. McLain,

chairman, chief executive officer, and president.  "Nabi Biopharmaceuticals'

Gram-positive infections franchise is being developed to target a broad array

of hospital-acquired bacterial infections through both prevention and

treatment approaches.  These Gram-positive products, once approved, have the

potential to significantly reduce hospital stays and costs, and ease patient

burden.  As with the S. epidermidis trial that we recently announced, we hope

to advance the type 336 trial rapidly, while we prepare to launch our flagship

product, StaphVAX, designed to prevent S. aureus types 5 and 8 in end-stage

renal disease patients."

   

"Type 336, much like the other types, is becoming increasingly resistant

to current treatment approaches," said Henrik S. Rasmussen, MD, PhD,

senior vice president of clinical, medical and regulatory affairs. "Immune-

compromised patients face an elevated risk of contracting Staph infections. In

these patient groups, S. aureus type 336 infections often result in increased

illness and death.  We are excited about taking a vaccine against type 336

into clinical trials.  When combined with StaphVAX, it should allow us to

provide protection against almost all S. aureus infections."

 

The type 336 Phase I study is a double-blinded, placebo-controlled study

to evaluate safety and antibody responses of the vaccine in up to 48 patients

at four different dosage levels.  Within each of these four dose groups there

will be 12 patients, nine receiving the type 336 vaccine and three receiving

placebo.  The doses will be administered in an escalating manner.  Nabi

Biopharmaceuticals expects to announce results from this trial in the second

half of 2005.

 

The annual economic cost of hospital-acquired infections totals

approximately $30 billion in the United States.  Nabi Biopharmaceuticals is

building a franchise of products designed to prevent and treat the infections

in approximately 2 million patients who contract these infections each year.

 

Source: Nabi Biopharmaceuticals

   

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