BOCA RATON, Fla., July 21 /PRNewswire-FirstCall/ -- 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 15-20 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, M.D., Ph.D., senior vice president, 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."
About the Type 336 Study
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.
About Nabi Biopharmaceuticals' Hospital-Acquired Infections Franchise
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 two million patients who contract these infections each year. The company's strategy to advance this franchise is three-fold:
Prevent and Treat the Clinical Problem:
Infections keep patients in the hospital longer and greatly increase illness, death and cost. Nabi Biopharmaceuticals is pursuing a combination approach, starting with Altastaph(TM) [Staphylococcus aureus Immune Globulin Intravenous (Human)] and StaphVAX(R) [Staphylococcus aureus Polysaccharide Conjugate Vaccine], with the potential to offer patients prevention and treatment for hospital-acquired bacterial infections and, upon hospital discharge, prevention of longer-term relapse after an infection. This innovative approach, initially focused on S. aureus infections, will be expanded to include S. epidermidis, Enterococcus and Gram-negative infections.
Leverage the Technology:
Nabi Biopharmaceuticals believes it has a core, patented technology that will overcome the resistance challenges associated with current antibiotics.
Build a Risk-balanced Platform:
Nabi Biopharmaceuticals is developing a portfolio of products to address the most prevalent and dangerous hospital-acquired infections, including S. aureus, S. epidermidis, Enterococcus, Pseudomonas and other Gram-negative bacteria and fungi, for the broadest array of at-risk patients.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop and market products that fight serious medical conditions. We are poised to capture large, commercial opportunities in our core business areas: Gram-positive bacterial infections, hepatitis, and kidney disease (nephrology), and opportunistically in nicotine addiction. We have three products on the market today: PhosLo(R) (calcium acetate), Nabi-HB(R) [Hepatitis B Immune Globulin (Human)], and Aloprim(TM) [Allopurinol sodium (for injection)] and a number of products in various stages of clinical and preclinical development.
The company filed its Marketing Authorization Application in Europe for its product candidate, StaphVAX(R) [Staphylococcus aureus Polysaccharide Conjugate Vaccine], in December 2004. The application was accepted for review in January 2005. StaphVAX is currently in a confirmatory Phase III clinical trial in the United States. StaphVAX is designed to prevent the most dangerous and prevalent strains of S. aureus bacterial infections. S. aureus bacteria are a major cause of hospital-acquired infections and are becoming increasingly resistant to antibiotics. The company's other products in development include Altastaph(TM) [Staphylococcus aureus Immune Globulin Intravenous (Human)], an antibody for prevention and treatment of S. aureus infections, NicVAX(TM) [Nicotine Conjugate Vaccine], a vaccine to treat nicotine addiction, and Civacir(TM) [Hepatitis C Immune Globulin (Human)], an antibody for preventing hepatitis C virus re-infection in liver transplant patients. For additional information on Nabi Biopharmaceuticals, please visit our website at: http://www.nabi.com .
This press release contains forward-looking statements that reflect the company's current expectations regarding future events. Any such forward- looking statements are not guarantees of future performance and involve significant risks and uncertainties. Actual results may differ significantly from those in the forward-looking statements as a result of any number of factors, including, but not limited to, risks relating to the possibility that our confirmatory Phase III clinical trial for StaphVAX or our plans to commercialize StaphVAX in the European Union and in the United States may not be successful; the company's ability to raise additional capital on acceptable terms; the company's dependence upon third parties to manufacture its products; the company's ability to utilize the full capacity of its manufacturing facility; reliance on a small number of customers; the future sales growth prospects for the company's biopharmaceutical products; and the company's ability to obtain regulatory approval for its products in the United States or abroad or to successfully develop, manufacture and market its products. These factors are more fully discussed in the company's Annual Report on Form 10-K for the fiscal year ended December 25, 2004 filed with the Securities and Exchange Commission.
Nabi BiopharmaceuticalsCONTACT: Constance Bienfait, Vice President, Investor Relations of Nabi,+1-561-989-5800
Web site: http://www.nabi.com/
