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Nabi Biopharmaceuticals Launches New Study to Evaluate StaphVAX(R)'s Ability to Provide Long-Term Protection From S. Aureus Infections in Chronic, High-Risk Patient Groups

Posted on: Tuesday, 20 September 2005, 09:00 CDT

ROCKVILLE, Md., Sept. 20 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals today initiated a repeated dosing study designed to evaluate the ability of StaphVAX(R) (Staphylococcus aureus Polysaccharide Conjugate Vaccine) to provide continuous protection in patient populations who are at high chronic risk for S. aureus infections. The trial will evaluate StaphVAX in end-stage renal disease (ESRD) patients on dialysis who are at high risk of contracting a S. aureus infection during their invasive and long-term treatment.

Thomas H. McLain, chairman, chief executive officer and president, Nabi Biopharmaceuticals, stated, "Nabi Biopharmaceuticals is developing what has the potential to be an innovative and holistic approach to combating life-threatening staph infections. We are developing both prevention and treatment approaches for a broad array of patients who are most at risk of these infections. Today's announcement about this new trial is important to us because it is aligned with our focus as a company to commercialize an industry-leading, end-to-end solution that could solve all aspects of the problem of staph infections -- improving patient outcomes, while also reducing the cost of care."

The clinical need for such an approach is significant: -- Over 20 million patients in the U.S. and Europe will be put at risk for contracting a life-threatening S. aureus infection this year. -- S. aureus infections keep patients in the hospital longer, increasing the economic burden on the healthcare system and extending patient suffering. -- "Smart" bugs have learned to evade current antibiotic treatments, thereby overwhelming patients' immune systems and causing harm. -- As high as 30% of patients treated for a methicillin-resistant S. aureus infections suffer a recurrence in a short amount of time.(1) About the Study

The study is a randomized, placebo-controlled study with two arms, and is comprised of a subset of 460 ESRD patients participating in Nabi Biopharmaceuticals' ongoing Phase III StaphVAX trials. One arm of the study will be comprised of 230 patients: 115 patients will receive two injections of the placebo eight months apart; and 115 patients will receive two injections of the placebo 12 months apart. The second arm will be comprised of another 230 patients: 115 patients will receive two injections of StaphVAX eight months apart; and 115 patients will receive two injections of StaphVAX 12 months apart. The goal of the study is to determine, after an initial booster dose at eight months, at which future time points repeat doses of StaphVAX would need to be given to achieve the optimal antibody levels in ESRD patients.

Henrik S. Rasmussen, MD, Ph.D., senior vice president, clinical, medical and regulatory affairs, Nabi Biopharmaceuticals, stated, "This study will determine the optimal time to administer additional StaphVAX injections in order to best protect patients who are at chronic risk from contracting a S. aureus infection.

Dr. Rasmussen continued, "The results of the study, although conducted specifically in ESRD patients, may also provide the basis for extrapolation into other high-risk patients who can benefit from ongoing protection from staph infections."

About ESRD Patients and S. aureus Infections

There are over 300,000 dialysis patients in the U.S., and the number of new patients beginning dialysis has increased 139 percent since 1988.(2) ESRD patients are at high-risk of contracting life-threatening S. aureus infections due to their compromised immune systems and the invasive nature of dialysis treatments. S. aureus infections remain the second leading cause of mortality (death) in ESRD patients, accounting for close to 20 percent of all deaths in 2001.(3) Based on current projections indicating that the number of ESRD patients in the U.S. will reach 2 million by 2030(4) and the growing resistance of S. aureus to antibiotics, infections in this patient population are a major healthcare concern. In addition to the patient burden, the costs associated with treating S. aureus infections are significant. According to studies conducted by Duke University, the cost of treating Methicillin-resistant S. aureus bacteremia in hospitalized ESRD patients totals $44,000 per case.

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 (MAA) 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 also filed MAA's in Europe to market Nabi-HB(R) Intravenous [Hepatitis B Immune Globulin (Human) Intravenous] under the trade name HEBIG(TM) for the prevention of hepatitis B disease in HBV-positive liver transplant patients; and for PhosLo(R) (calcium acetate), which is already marketed in the U.S. 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 United States may not be successful; the possibility that we may not realize the value of our acquisition of PhosLo; 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; the impact on sales of Nabi-HB from patient treatment protocols and the number of liver transplants performed in HBV-positive patients; 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.

(1) Brigham and Women's Hospital (Clinical Infectious Diseases, 2003; 36: 281-285 (2) U.S. Renal Data System, USRDS 2004 Annual Data Report: Atlas of End- Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2004 (3) U.S. Renal Data System, USRDS 2003 Annual Data Report: Atlas of End- Stage Renal Disease in the United States, National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Bethesda, MD, 2003. (4) Szczech, LA, Lazar, IL. Projecting the United States ESRD population: Issues regarding treatment of patients with ESRD. Kidney International; Vol. 66 (Supplement 90):S3-7, September 2004.

Nabi Biopharmaceuticals

CONTACT: Constance C. Bienfait, Vice President, Investor Relations,+1-561-989-5800

Web site: http://www.nabi.com/

Source: PRNewswire-FirstCall

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