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Nabi Biopharmaceuticals Announces Altastaph(TM) Phase II Trial
Results in Neonates
Analysis Drives Development of Next Generation Product
ROCKVILLE, Md., Nov. 17 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals
today announced Phase II clinical trial results for Altastaph(TM)
[Staphylococcus aureus Immune Globulin Intravenous (Human)]. This Phase II
trial was conducted in premature, low birth-weight babies (neonates). Altastaph
is the company's polyclonal antibody for prevention and treatment of
Staphylococcus aureus infections, which can afflict at-risk patients including
those who do not have time or are too immune-compromised to respond to a
vaccine to prevent infection. Phase II clinical trials are generally small
studies, sized to evaluate safety and the body's reaction to the drug under
development. Results from this trial in neonates have demonstrated that
Altastaph was safe and exhibited a good pharmacokinetic profile, the primary
endpoints of the trial. The antibody levels following administration of
Altastaph were well above the targeted level of 80-100 mcg/ml, which is
believed to be protective against infections in neonates. However, the
incidence rate of S. aureus infections observed in the neonates was very low,
only 3%, versus an expected rate of 5 to 7% based on published literature and
recent clinical studies. As a result, the company is unable to make any
inference about Altastaph's effect on infections in neonates, as only three
infections were reported in each of the placebo and treated arms of the study.
Altastaph Development Program and Milestones
In order to maximize the clinical and commercial potential for Altastaph in
preventing bacterial infections in neonates, Nabi Biopharmaceuticals plans to
rapidly expand and advance its Altastaph development program. The company will
focus its effort on its next generation Altastaph product that will be
developed to prevent a majority (up to two-thirds) of bacterial infections
observed in neonates (S. aureus Types 5, 8 and 336 and S. epidermidis). S.
epidermidis, one of the most prevalent and dangerous bacteria to infect
neonates, is a cause of significant illness and death.
Already during the fourth quarter of 2004, Nabi Biopharmaceuticals has
completed formulation of a clinical lot of its S. epidermidis vaccine that can
also be used as a stimulating agent for this next generation Altastaph product.
The company expects to complete formulation of its Type 336 S. aureus vaccine
in the first quarter of 2005 and will conduct initial safety and immunogenicity
studies with these vaccines in 2005. This will allow for the manufacture of a
clinical lot of the next generation of Altastaph in the second half of 2005 to
support further clinical studies in 2006. The Altastaph development program,
including the timing and type of clinical studies, will be determined after
consultation with regulators in the United States and Europe. Altastaph has
been granted fast track designation in the United States for its use in
preventing infection in neonates.
"We are committed to the development of our novel antibody approach to prevent
and treat deadly bacterial infections. We will continue to advance our work in
neonates, recognizing the significant medical need in this very vulnerable
patient population, while also defining other at-risk patient groups who could
benefit from our approach," stated Thomas H. McLain, chairman, chief executive
officer and president, Nabi Biopharmaceuticals. "The development program we
have in place for this next generation product is important for many reasons.
While our initial plan to begin Phase III clinical testing of Altastaph in 2005
will be delayed, we believe this next generation product will provide important
advantages for physicians when compared to other similar products under
development. By developing a product that can prevent both S. aureus and S.
epidermidis infections, we will be in a unique position to help reduce illness,
complications and death in at-risk patients. In addition, we plan to leverage
the value of the patent portfolio we have built around our next generation
programs."
Henrik S. Rasmussen, M.D., Ph.D., senior vice president, clinical research,
medical and regulatory affairs and project management, Nabi Biopharmaceuticals,
stated, "By including antibodies to prevent infections due to S. epidermidis or
S. aureus Type 336, we should be able to demonstrate the benefits from
Altastaph therapy against a broader range of infections that are the cause of
this challenging and unmet medical need. This next generation product is
expected to provide protection from all the strains of S. aureus bacteria
causing serious infection in neonates. The additional protection against S.
epidermidis bacteria will also be very important because these infections are a
significant cause of illness and death in these patients."
About the Phase II Altastaph Study
The Altastaph study was a Phase II, double-blinded, placebo-controlled trial
conducted in 20 neonatal intensive care units across the United States. Half of
the 200 very low birth-weight infants studied received two doses of Altastaph
14 days apart starting 3 to 7 days after birth and the other half were given
placebo. The primary endpoints of the trial were to evaluate the safety and
pharmacokinetics of Altastaph.
About Altastaph
Altastaph is a polyclonal antibody for the prevention and treatment of S.
aureus infections, and is based on the same mechanism of action as StaphVAX.
Altastaph, an orphan drug recently granted Fast Track Designation, is being
developed for patients at immediate risk of infection or patients whose immune
systems are too suppressed to respond to a vaccine, such as neonates, or
premature babies. Premature babies are at great risk of S. aureus infections
because of their poorly developed immune systems. Neonates contracting such an
infection have a poor prognosis. In addition to the neonate indication,
Altastaph is being studied in hospitalized adults with confirmed, persistent S.
aureus bacteremia to observe whether resolution of these infections can be
accelerated. Data from this trial, which will primarily monitor Altastaph's
safety and pharmacokinetics, as well as any effect on S. aureus bacteremia, is
expected by the end of 2004.
About Hospital-acquired Gram-positive Infections in Neonates
Hospital-acquired Gram-positive infections, such as S. aureus and S.
epidermidis, represent a significant problem in low birth-weight neonates who
have poorly developed immune systems. In addition, these infants are often
hospitalized for prolonged periods in neonatal intensive care units during
which time they may undergo invasive medical procedures that increase the risk
of S. aureus, S. epidermidis and other bacterial infections. Gram- positive
infections in neonates are serious and are associated with a substantial
increase in illness and death. Even if these infants survive their infections,
their hospital stays are often prolonged. The frequency of antibiotic
resistant S. aureus infections continues to increase and now approaches 60% or
more in some healthcare settings. The recent identification of resistance to
vancomycin, widely determined to be the current antibiotic of last resort to
treat S. aureus infections, has led to recognition that antibiotic therapy
alone is not sufficient to address this significant and growing problem and
that adjunctive approaches must be developed and evaluated.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals applies its knowledge of the human immune system to
commercialize and develop products that address serious, unmet medical needs.
The company's focus is in the areas of infectious, autoimmune and addictive
diseases. In addition to four marketed products (PhosLo(R), Nabi- HB(R), WinRho
SDF(R), Aloprim(TM)), the company has several products in various stages of
preclinical and clinical testing. Nabi Biopharmaceuticals has advanced
StaphVAX(R) to Phase III clinical development. StaphVAX is designed to prevent
the most dangerous and prevalent strains of Staphylococcus 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), an antibody for
prevention and treatment of S. aureus infections, currently in Phase II
testing, NicVAX(TM), a vaccine to treat nicotine addiction, and Civacir(TM), 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 EU may not be successful; the possibility that we
may not realize the value of our acquisition of PhosLo; 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 27,
2003 filed with the Securities and Exchange Commission.
DATASOURCE: Nabi Biopharmaceuticals
CONTACT: Mark Soufleris, Vice President, Investor & Public Relations,
+1-561-989-5800
Web site: http://www.nabi.com/