Nabi Biopharmaceuticals Announces Altastaph(TM) Phase II Trial Results in Neonates
17 Noviembre 2004 - 3:05PM
PR Newswire (US)
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/
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