-- StaphVAX Shown to Induce Significant Increases in Antibody Levels in
Patients Undergoing Cardiac Surgery and Other
Invasive Cardiovascular Procedures --
BOCA RATON, Fla., July 12 /PRNewswire-FirstCall/ -- Nabi
Biopharmaceuticals (Nasdaq: NABI) announced today positive results from the
first in a series of immunogenicity studies of StaphVAX(R) (Staphylococcus
aureus Polysaccharide Conjugate Vaccine) in additional patient populations at
risk for S. aureus infections. StaphVAX is Nabi Biopharmaceuticals' phase 3
investigational vaccine designed to prevent the most prevalent strains of S.
aureus bacterial infections.
Patients undergoing various types of surgery, including cardiovascular
surgery, are at increased risk of developing severe S. aureus infections. The
risk is greatest during the immediate post-operative period while patients are
still in the hospital and the next few weeks while recovering from surgery.
This study was designed to provide evidence that a broader and generally
healthier at-risk patient group, such as patients undergoing cardiovascular
surgery, can achieve antibody levels equal to, or greater than, the protective
antibody levels attained in immunocompromised end-stage renal disease (ESRD)
patients in earlier clinical trials. In addition, the study was designed to
assess safety and toleration of the vaccine in these patients.
The phase 2b immunogenicity study included a total of 120 patients from 15
cardiovascular surgery centers in the United States. This two-part, six-month
study was double-blinded through the first six weeks following vaccination,
when surgery patients are at greatest risk for post-surgical infections.
Subjects were vaccinated prior to their cardiovascular procedure in order to
assess their antibody levels during the period of greatest risk of S. aureus
infection. While these patients were healthier than the ESRD patients studied
in the Company's phase 3 efficacy trial, 25 percent were partially
immunocompromised due to diabetes. Substantial increases in antibody levels
were achieved in the vaccine recipients by day 7, and by day 14, the levels
were far above the estimated protective antibody levels measured in
compromised ESRD patients. On day 14, 93 percent of the patients had antibody
levels above the estimated protective levels. This compares favorably to the
80-85 percent response rate observed in ESRD patients. The vaccine was very
well tolerated. No serious adverse events were attributed to the vaccine.
Reactions to the vaccine were generally mild and of short duration, similar to
those experienced by ESRD patients. The second, unblinded phase of the study,
which will provide more comprehensive assessment of the duration of vaccine
effect in this population by following patients for up to six months, is still
ongoing.
"These results support the potential to broaden the patient population
beyond dialysis patients who can benefit from the protection afforded by
StaphVAX against S. aureus. We expect to include these results in our 2005
Biologics License Application filing in the United States as well as a
supplemental Marketing Authorization Application in Europe," stated Henrik S.
Rasmussen, M.D., Ph.D., senior vice president, clinical, medical and
regulatory affairs, Nabi Biopharmaceuticals. "This study is firmly aligned
with our commercial growth strategy to build the industry's broadest and
deepest Gram-positive bacterial infections franchise. We look forward to
presenting the full dataset from this study at an upcoming scientific meeting,
and as a full paper."
StaphVAX is currently in a confirmatory phase 3 trial designed to confirm
that it can prevent S. aureus infections in ESRD patients. Patients with ESRD
are at high risk of developing S. aureus bacterial infections and are among
the most difficult patients to treat because they are immunocompromised due to
their debilitating, underlying disease and because dialysis access provides an
opportunity for bacteria to be introduced into their bloodstream. However,
there are a large number of other patient populations who are at substantial
risk for contracting S. aureus infections, such as patients undergoing
cardiothoracic or orthopedic surgery, in particular when it involves
implantation of prosthetic devices. It is estimated that there are a total of
12 million patients in the United States who are at risk of contracting these
infections on an annual basis.
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, is 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 United States 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 S. aureus Infections and Resistance Issues
An estimated 12 million patients are at risk for developing an S. aureus
infection each year in the United States. In the country's 7,000 acute care
hospitals, S. aureus is the leading cause of hospital-based bloodstream
infections and has a crude mortality rate of 25 percent. The risk is highest
for patients who are immunocompromised and for those who suffer from chronic
debilitating illnesses, as well as for people treated with invasive devices
such as a prosthetic or dialysis devices. S. aureus bacteria are becoming
increasingly resistant to available antibiotics. It is estimated that over 95
percent of patients worldwide with S. aureus infections no longer respond to
first-line antibiotics, such as penicillin or ampicillin. Methicillin is an
alternative treatment, but nearly 60 percent of strains of S. aureus in the
United States are now methicillin-resistant, and this number continues to
rise. In other parts of the developed world, the rate of methicillin-
resistant S. aureus incidence continues to grow, with resistance rates close
to 80 percent in some Asian countries.
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 to prevent and treat the 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, 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
four core business areas: Gram-positive bacterial infections, hepatitis,
kidney disease (nephrology), and 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 3 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 3 clinical trial for StaphVAX or our plans to
commercialize StaphVAX in the European Union and in the United States may not
be successful; the risk that StaphVAX is not effective in patients who undergo
cardiovascular surgery, the ability to file the BLA in the United States and
the MAA in Europe, 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.
SOURCE Nabi Biopharmaceuticals
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Related links:
http://www.nabi.com
CONTACT:
Constance C. Bienfait, Vice President,
Investor Relations of Nabi Biopharmaceuticals, +1-561-989-5800
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