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ROCKVILLE, Md. -- Nabi Biopharmaceuticals announced today the initiation of the first human clinical study of its vaccine being developed to prevent Staphylococcus epidermidis infections in at-risk patients. At-risk patients include neonates, patients with indwelling catheters and patients undergoing certain types of surgery. The Phase l study will evaluate safety and immune response of the vaccine in healthy volunteers.
There are numerous species of staph bacteria, but S. aureus and S. epidermidis are responsible for almost all staph infections in the hospital. S. aureus accounts for approximately 60 percent of all Gram-positive hospital-acquired infections, with S. epidermidis accounting for an additional 20 percent. S. epidermidis usually inhabits the human skin and nasal surfaces, and can spread to the blood through breaks in the nasal membranes and the skin. S. epidermidis has the same level of resistance to antibiotics as S. aureus bacteria.
The study announced today builds on the extensive clinical data supporting the company's vaccine to prevent S. aureus infections, StaphVAX [Staphylococcus aureus Polysaccharide Conjugate Vaccine]. StaphVAX is in Phase III clinical trials to prevent S. aureus infections in end-stage renal disease patients. In addition, immunogenicity studies in the United States and United Kingdom are underway in orthopedic surgery patients who are at high-risk of developing S. aureus infections. The company also has vaccines in preclinical development to prevent enterococcal infections and S. aureus
"Bacterial infections are increasingly becoming a serious and often deadly
consequence of healthcare," said Thomas H. McLain, chairman, chief executive
officer and president, Nabi Biopharmaceuticals. "Our innovative application
of vaccines and antibodies to address this significant medical challenge has
the potential to not only improve patient outcomes and save lives, but to
significantly lower healthcare costs. The initiation of this study reinforces
our commitment to prevent the most prevalent and dangerous bacterial
infections in at-risk patients, which if addressed early on, will reduce
hospital stays, costs and ease patient burden."
Henrik S. Rasmussen, MD, PhD, senior vice president, clinical, medical
and regulatory affairs, Nabi Biopharmaceuticals, stated, "Patients most at
risk of contracting S. epidermidis are those with weakened immune systems,
such as premature babies, patients receiving cancer chemotherapy and
diabetics. At particular risk are immune compromised patients who have
undergone major medical interventions involving chronic indwelling catheters
or other interventional medical devices. In these patient populations, S.
epidermidis infections often result in substantial illness and death. To add
to the problem, S. epidermidis bacteria are becoming increasingly resistant to
current antibiotics." Rasmussen continued, "This study will evaluate safety and immune
response of the vaccine at a variety of dose levels, and will provide an
important addition to StaphVAX in the war against multi-drug resistant
hospital-acquired bacterial infections."
Source: Nabi Biopharmaceuticals