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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
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