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Nabi Biopharmaceuticals Presents Data Showing Patients Treated With Altastaph Were Relieved of Fever and Bacteremia Sooner Than the Placebo Group

Posted on: Friday, 7 October 2005, 18:00 CDT

ROCKVILLE, Md., Oct. 7 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals announced today, for the first time, data showing that patients treated with Altastaph(TM) [Staphylococcus aureus Immune Globulin Intravenous (Human)] had a shorter duration of bacteremia (bloodstream infections) and fever versus the placebo group. As previously reported, the treated group also left the hospital sooner. Altastaph is Nabi Biopharmaceuticals' investigational human antibody-based product in development to treat adult in- hospital patients with persistent S. aureus bacteremia.

Mark E. Rupp, M.D. from the University of Nebraska Medical Center, presented the full Phase I/II results at the 43rd Infectious Diseases Society of America (IDSA) Annual Meeting in San Francisco, California.

"Infection due to Staphylococcus aureus is a significant medical problem that is, unfortunately, increasingly observed," stated Dr. Rupp. "The growing prevalence of antibiotic-resistance in staphylococci reinforces the need for new antibiotics and innovative measures, such as Altastaph. This Phase I/II study showed that Altastaph was generally well tolerated, similar to other IVIG products. Patients treated with Altastaph had high levels of antibodies, which result in the killing of bacteria. Additional studies are warranted to further define the efficacy of Altastaph, a promising therapeutic agent."

Dr. Rupp's presentation focused on the results of the Altastaph U.S. Phase I/II clinical trial in treating adult in-hospital patients with persistent S. aureus bacteremia. In this study there was a 36 percent reduction in median time from administration of the study drug to hospital discharge in the Altastaph-treated patients as compared to the placebo-treated patients (nine days in the Altastaph group versus 14 days in the placebo group). This substantial reduction in the length of hospital stays for the Altastaph- treated group indicates that S. aureus antibodies provided by Altastaph could be associated with considerable medical as well as health economic benefit in the treatment of persistent S. aureus infections.

The study results also showed a shorter duration of bacteremia (one day in the Altastaph group versus two days in the placebo group) and fever (two days in the Altastaph group versus seven days in the placebo group).

Dr. Rupp's oral presentation took place today, Friday, October 7, 2005, from 5:30 to 5:45pm PT at The Moscone Center, San Francisco, California. Dr. Rupp is one of the principal investigators for the Altastaph clinical trials.

Henrik S. Rasmussen, M.D, Ph.D., senior vice president, clinical, medical and regulatory affairs, Nabi Biopharmaceuticals, stated, "The IDSA is a premier organization with a history of communicating some of the most important scientific advances in infectious disease prevention and treatment. We are delighted to have an opportunity to present this data showing additional benefits of Altastaph in the treatment of patients with staph infections. Based on these results, we anticipate initiating a larger 'proof- of-concept' Phase II study by the end of this year or early next year."

About Altastaph

Altastaph is an investigational human antibody-based product containing high levels of antibodies to capsular polysaccharides (protective outer sugar coatings on S. aureus bacteria) from S. aureus types 5 and 8, which together account for approximately 85 percent of all S. aureus infections. Altastaph is produced by immunizing healthy volunteers with StaphVAX(R) (Staphylococcus aureus Polysaccharide Conjugate Vaccine), Nabi Biopharmaceuticals' vaccine being investigated for the prevention of S. aureus infections.

In the U.S., Altastaph has been designated an orphan drug and has received Fast Track Designation for providing immediate protection against S. aureus infections in low-birth-weight infants (neonates). Altastaph is also being developed for prophylactic use to provide short-term, immediate protection to patients who either cannot wait for the vaccine effect to occur or whose immune systems are too compromised to mount an adequate response to a vaccine. Patients in intensive care units and burn units may also benefit from Altastaph in conjunction with standard-of-care therapy, including antibiotic treatment.

In September 2005, Nabi Biopharmaceuticals received a favorable opinion in Europe regarding Orphan Medicinal Product (OMP) designation for Altastaph for the treatment of Staphylococcus aureus bacteremia. OMP designation acknowledges the significant medical need for a product and provides a number of development and commercialization advantages. Based upon this favorable opinion, Nabi Biopharmaceuticals expects to receive the formal OMP designation from the European Commission later this year.

StaphVAX and Altastaph: A Powerful Combination

Candidate products StaphVAX and Altastaph share a common mechanism of action. When antibodies to S. aureus attach to the outer capsule of the bacteria as it circulates in the blood, they trigger an immune response, enabling the body's white blood cells to recognize the bacteria and destroy it before it leads to a serious secondary infection.

Nabi Biopharmaceuticals is pursuing a combination therapy approach to address an array of bacterial pathogens that affect a variety of at-risk patients. A combination approach that uses Altastaph (for treatment of S. aureus) and StaphVAX upon hospital discharge (for long-term prevention from relapse) will offer important therapeutic and preventive benefits to patients afflicted with these life-threatening infections. Clinical data from Brigham and Women's Hospital in Boston, Massachusetts showed that patients treated for a serious S. aureus infection and released from the hospital face a very high risk (approximately 30 percent) of recurrence within the initial 18 months after discharge.

About S. aureus Infections

S. aureus is the most common cause of serious hospital-acquired bloodstream infections. Staphylococcal infections are difficult to treat because the bacteria, in most cases, are resistant to available antibiotics. This rise of antibiotic resistance has markedly curtailed options for treating S. aureus infections. According to the current estimates by the U.S. Centers for Disease Control and Prevention (CDC), more than two million patients in the U.S. each year contract an infection as a result of exposure to a pathogen while receiving care in a hospital. S. aureus can spread from the blood (bacteremia), to the bones (osteomyelitis), or the inner lining of the heart and its valves (endocarditis), or cause abscesses in internal organs such as the lungs, liver and kidneys. People most at risk for these infections are surgical patients, trauma or burn victims, newborns whose immune systems are not yet developed, and patients with chronic illnesses such as diabetes, cancer, or lung or kidney diseases. People whose immune systems are suppressed due to disease, chemotherapy, or radiation therapy are generally more susceptible to these bacterial infections.

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, kidney disease (nephrology), and opportunistically in nicotine addiction. We have three products on the market today: PhosLo (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 U.S. 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 U.S. may not be successful; the possibility that we may not realize the value of our acquisition of PhosLo; the ability of the company to prevail in patent litigation; 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 U.S. 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 Biopharmaceuticals

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

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

Source: PRNewswire-FirstCall

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