- Company Expects to Announce Antibody and Safety Data By End of 2005;
Poised to Initiate Phase III Pivotal Trial by Year-end -
BRAY, Ireland, July 20 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals
(Nasdaq: NABI) announced today that it has completed enrollment for its
European-based NicVAX(TM) (Nicotine Conjugate Vaccine) Phase II dose-ranging
study in smokers. NicVAX is a novel, innovative, and proprietary
investigational vaccine being developed to prevent and treat nicotine
addiction.
The study, designed to evaluate NicVAX's safety, antibody response to
nicotine, and measure smoking cessation/nicotine dependency, is a randomized
dose-ranging study in smokers. The four NicVAX dose levels, 100, 200, 300,
and 400 mcg per injection, will be given over a six-month period with 10
patients included per dose group. Based on clinical trial results generated
to date, Nabi Biopharmaceuticals has observed no significant toxicity through
the 200 mcg dose level, hence the current study is designed to evaluate
whether higher doses of NicVAX could further increase anti-nicotine antibody
levels without increasing toxicity.
"Tobacco use is expected to kill four million people worldwide within the
next year," said Thomas H. McLain, chairman, chief executive officer and
president. "Nabi Biopharmaceuticals' NicVAX is potentially advantageous in
three important and commercially strategic ways: The vaccine appears to be
very well tolerated, even at 200 mcg, the highest dose level tested, allowing
us to explore higher and potentially even more efficacious doses; our unique
and proprietary mechanism of action for NicVAX, using the same carrier protein
as we use in StaphVAX, is based on an established mechanism of action; and, we
believe NicVAX is the most advanced smoking cessation product of its kind in
development. By the end of 2005, we intend to announce preliminary results
from this European Phase II study, be in a position to initiate a European
Phase III pivotal trial, and begin to manufacture commercial scale material in
our own vaccine manufacturing facility in Boca Raton, Florida."
Positive Clinical Results to Date
In September 2004, Nabi Biopharmaceuticals announced the results from a
U.S. Phase II trial with NicVAX that indicated a 33 percent quit rate in
smokers who received NicVAX at the highest dose level versus 9 percent in a
placebo group. This was a NicVAX-only effect without any additional
interventions, supplemental treatments, behavioral support or counseling. (In
a study testing a competing treatment, where the vaccine treatment was
supplemented with psychological counseling, the placebo response rate reached
31 percent).
The objectives of the U.S. study were to show that NicVAX was able to
safely generate nicotine-specific antibodies in smokers, and to assess its
potential use as an aid in smoking cessation. Smoking cessation was confirmed
by cotinine and carbon monoxide levels, which are biochemical markers of
smoking. Nicotine dependency was measured by a questionnaire and also showed
a substantial reduction at the top dose of NicVAX as compared to placebo or
the lower dose levels.
Henrik S. Rasmussen, M.D., Ph.D., senior vice president, clinical, medical
and regulatory affairs, stated, "In order to be clinically successful, smoking
approaches must be safe, efficacious and result in long-term quit rates for
smokers. Based on clinical results observed to date, we believe NicVAX is
well positioned to achieve this goal. We also observed a correlation between
anti-nicotine antibody titer levels and anti-smoking activity. As a result,
we believe that even higher dosage levels could potentially translate into
greater antibody response in smokers. We believe that the results from the
NicVAX dose optimization study will provide further compelling evidence that a
vaccine approach for smoking cessation is not only a viable approach, but that
NicVAX will provide smokers with a much needed smoking aid that supports long-
term quit rates, reduced cigarette consumption and reduced dependence on
nicotine. We expect that this study will provide an important basis on which
to design and advance our pivotal efficacy trials later this year."
Unique Mechanism of Action
NicVAX is a nicotine derivative bound chemically to a specially selected
carrier protein using Nabi Biopharmaceuticals' patented vaccine technology.
NicVAX is designed to cause the immune system to produce antibodies that
bind to nicotine and prevent it from entering the brain. It is believed that
these nicotine antibodies will act like a "sponge" soaking up nicotine as it
circulates in the bloodstream and preventing it from reaching the brain. The
positive stimulus in the brain that is normally caused by nicotine would then
no longer be present, thereby taking away the physical motivation for smoking,
consequently helping people to quit.
Studies have showed that vaccination with NicVAX can prevent nicotine from
reaching the brain and block the effects of nicotine, including effects that
can lead to addiction or can reinforce and maintain addiction.
About Nicotine Addiction and the European Region
Despite widespread knowledge of tobacco's dangerous health effects,
smoking continues to pose a serious public health threat, as many smokers are
unable to quit, due in large part to tobacco's addictive properties. Nicotine
is responsible for the psychoactive and addictive effects of smoking.
Smoking a cigarette immediately releases nicotine into the blood, where it
passes through the blood brain barrier and enters the brain. Once in the
brain, nicotine stimulates the release of neurotransmitters (such as dopamine)
that generate positive sensations, such as pleasure, relaxation and appetite
suppression. It is this release of neurotransmitters, especially dopamine
that is responsible for tobacco users' addiction to nicotine.
Tobacco is the second major cause of death in the world. Five million
people die each year due to tobacco-related illnesses. Half of those who
smoke today, 650 million, will die from tobacco use.(1) The World Health
Organization (WHO) recognizes that nicotine is an addictive drug that provokes
dependence. Only a small percentage of smokers, 0.5 percent - 5 percent each
year in the European Region, achieve long-term abstinence without help or
support. Even in countries where tobacco control policies are instituted and
where the health risks of tobacco use are commonly understood, smoking
prevalence rates have not decreased.(2) Each year, tobacco causes $75.5
billion in direct medical costs and $81.8 billion in smoking-attributable
productivity costs.
In 2003, the WHO Regional Office for Europe issued The WHO European
Strategy for Smoking Cessation Policy, which states that increasing tobacco
cessation in adults and reducing the number of young people who start smoking
is critically important to improving public health.(3) Studies have proven
that quitting smoking at any age has immediate as well as long-term benefits,
reducing a person's risk of dying from a smoking-related disease or illness
and improving overall health.(4)
The European Region of WHO, with only 15 percent of the world's
population, faces nearly one third of the worldwide burden of tobacco-related
diseases. In 2000, 1.6 million deaths in the European Region were attributed
to tobacco.(5) While smoking prevalence has fallen from 45 percent to 30
percent over the past 30 years, current rates show no further reduction. The
current average annual reduction of smoking prevalence is only 1 percent.
Most notably, smoking prevalence rates have risen among young people, women
and lower socioeconomic groups.(6)
By reducing the global cigarette consumption per adult in half by 2020,
approximately one third of tobacco-related deaths would be avoided in that
year, which would almost halve the tobacco-related deaths in the second
quarter of the century.(7) These changes could prevent between 7 and 10
million tobacco-related deaths by 2025 in the European Region.(8)
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 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'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 web site: 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) World Health Organization. Tobacco Free Initiative: Why is tobacco a
public health priority?. Available from
http://www.who.int/tobacco/about/en/ Accessed on October 12, 2004.
(2) World Health Organization. WHO European Strategy for Smoking
Cessation Policy. WHO Regional Office for Europe, 2003.
(3) World Health Organization. WHO European Strategy for Smoking
Cessation Policy. WHO Regional Office for Europe, 2003.
(4) U.S. Department of Health and Human Services. The Health Consequences
of Smoking: A Report of the Surgeon General. U.S. Department of
Health and Human Services, Centers for Disease Control and
Prevention, National Center for Chronic Disease Prevention and Health
Promotion, Office on Smoking and Health, 2004.
(5) World Health Organization. WHO European Strategy for Smoking
Cessation Policy. WHO Regional Office for Europe, 2003.
(6) World Health Organization. European Strategy for Tobacco Control. WHO
Regional Office for Europe, 2002.
(7) World Health Organization. WHO European Strategy for Smoking
Cessation Policy. WHO Regional Office for Europe, 2003.
(8) World Health Organization. WHO European Strategy for Smoking
Cessation Policy. WHO Regional Office for Europe, 2003.
SOURCE Nabi Biopharmaceuticals
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Related links:
http://www.nabi.com
CONTACT:
Connie Bienfait, Vice President, Investor
Relations of Nabi Biopharmaceuticals, +1-561-989-5800
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