- Study Designed to Demonstrate Vaccine's Effectiveness in Smoking
Cessation; Results Expected Mid-2007 -
ROCKVILLE, Md., May 24 /PRNewswire-FirstCall/ -- Nabi
Biopharmaceuticals today announced that it has initiated a Phase IIB
"proof-of-concept" study for NicVAX(R) (Nicotine Conjugate Vaccine), the
company's novel, innovative and proprietary investigational vaccine being
developed to treat nicotine addiction and prevent smoking relapse. The
study will evaluate the effectiveness of an optimized formulation of the
vaccine manufactured at commercial scale in the company's vaccine plant in
Florida. The study protocol is based on consultations with U.S. and EU
regulators on the design and endpoints for Phase III efficacy studies.
Results from this study are expected to be announced in mid-2007. The
timing of this study positions the company to be able to initiate Phase III
efficacy studies in the second half of 2007.
Thomas H. McLain, chairman, CEO and president, Nabi Biopharmaceuticals,
stated, "This is an important milestone for Nabi Biopharmaceuticals and for
the over one billion smokers in the U.S. and across the world who want to
quit their addictive habit. Key elements in the design and conduct of this
proof- of-concept study support our belief that NicVAX is the most advanced
smoking cessation vaccine in this market. By following the expected design
of Phase III efficacy trials, this study is intended to demonstrate the
benefit of the optimized vaccine formulation in terms of efficacy, antibody
levels and safety. Results from this study will demonstrate the quit rate
we would expect from Phase III studies of the vaccine by adding other key
elements in smoking cessation programs including behavioral modification
and counseling. The results of this study will be important in
demonstrating the vaccine's efficacy and positioning us to initiate Phase
III studies in the second half of next year. It is also important to note
that this study will help to evaluate an important additional benefit and
differentiator with a vaccine approach to smoking cessation. We will also
measure the benefit of long- lasting nicotine antibodies on preventing the
high rates of relapse within the first year in smokers who have quit their
habit."
Henrik S. Rasmussen, M.D., Ph.D., senior vice president, clinical,
medical and regulatory affairs, Nabi Biopharmaceuticals, stated, "Important
new developments in smoking cessation have been very supportive of our
vaccine approach. The recent approval of CHANTIX(TM) (varenicline) has
provided strong support for the NicVAX mechanism of action, namely that
blocking nicotine from reaching receptors inside the brain prevents the
pleasurable and addictive response to smoking and thus promotes smoking
cessation. We believe that our NicVAX approach will add two important
advantages over a pill-based approach. First, NicVAX works by preventing
nicotine from entering the brain, rather than replacing nicotine or
blocking receptors with chemicals inside the brain. NicVAX works by
enabling the immune system, the human body's natural defense mechanism.
Second, treatment with other therapies, like CHANTIX, is stopped within a
few months or the smoker can simply stop taking their therapy and be at
high risk for relapse. In contrast, antibodies from NicVAX are expected to
last 12 months or longer and should support getting through the critical
first year in which relapse ranges as high as 95% with other therapies. A
boosting schedule could also be developed for smokers who feel they
continue to be at high risk for relapse after one year."
Dr. Rasmussen continued, "With our intellectual property in the U.S.
and Europe and the capacity to produce NicVAX in our own plant, we are in
an excellent position to drive this program forward and make a real
difference in the lives of millions of people afflicted with nicotine
addiction."
The initiation of this Phase IIB study for NicVAX is an important
milestone for Nabi Biopharmaceuticals and positions the company to continue
to rapidly advance this key program. This study, designed with extensive
input from the U.S. Food and Drug Administration (FDA), the European Agency
for the Evaluation of Medical Products (EMEA), the National Institute on
Drug Abuse (NIDA) and leading external consultants, is designed to
establish "proof-of- concept" and at the same time identify the optimal
dose and dosing regimen for subsequent Phase III pivotal trials. By
starting this study on schedule, the company expects to be well positioned
to initiate Phase III clinical trials in the U.S. and Europe in the second
half of 2007. During 2006, the company will also continue to advance
efforts to secure external funding for the Phase III efficacy trials. In
addition, the company will continue to advance efforts to establish a
corporate partnership for commercialization of NicVAX.
How NicVAX is Designed to Work
NicVAX is designed to stimulate 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 is no longer present, thereby eliminating the addictive
properties of nicotine and, consequently, helping people to quit. Because
the ability of the body's immune system to produce these antibodies is
expected to be long lasting, it is believed NicVAX will also be effective
in preventing smoking relapse, a significant challenge with existing
smoking cessation therapies. This is an important differentiator between
NicVAX and existing anti-smoking treatment modalities. By preventing the
pleasurable response ("the rush") that occurs when nicotine reaches the
brain, NicVAX takes away what is believed to be the main reason that most
people cannot stop smoking.
Development Progress to Date
Early clinical data indicates that NicVAX, if approved, could
potentially be one of the most efficacious smoking cessation products
available. In a Phase II clinical trial, NicVAX achieved a 33 to 40 percent
quit rate in smokers who received the highest dose level versus nine
percent in the placebo group. These results represented a vaccine-only
effect, as patients were not given any supplemental treatments, behavioral
support or counseling. It is expected that the response rate would be
further improved as behavioral support and counseling are built into the
program.
In March 2006, Nabi Biopharmaceuticals announced that NicVAX had
received Fast Track Designation from the FDA, which facilitates the
development of products that treat serious diseases where an unmet medical
need exists.
In January 2006, the company announced that a new formulation of NicVAX
with less vaccine adjuvant was safe and produced high levels of antibodies
to nicotine in smokers. Importantly, antibody levels were consistent with a
vaccine with higher adjuvant levels that demonstrated up to a 40 percent
success rate in smoking cessation in an earlier Phase II trial. Both
vaccine formulations are being evaluated in the Phase II "proof-of-concept"
study initiated in May 2006.
In September 2005, the company announced that it had received a $4.1
million grant from NIDA, part of the National Institutes of Health, which
is expected to fully offset the external costs of the Phase II
"proof-of-concept" clinical study. NIDA has contributed scientific and
clinical expertise to the program and has funded the costs for toxicology
testing and earlier clinical trials in the U.S.
Nabi Biopharmaceuticals' intellectual property portfolio for technology
related to NicVAX includes both issued and pending patents in the U.S. In
addition, the company holds granted patents in 18 European countries, plus
patents and pending patent applications in numerous other countries around
the world.
About the Phase IIB Study
The Phase IIB study for NicVAX is a double-blinded, placebo-controlled
dose ranging study comprised of approximately 300 patients, a large enough
sample size to establish both "proof-of-concept" and optimal dose
identification for the Phase III program. The primary endpoint of the study
is the abstinence rate at six months. Abstinence will be evaluated by
several measures, including reported cigarette consumption, chemical
markers of nicotine in the bloodstream, and behavioral assessment.
Secondary endpoints include the abstinence rate at 12 months, total
cigarette consumption, titer levels, safety and nicotine dependency. Study
results from the initial six months assessment, which include the primary
endpoint, are anticipated in mid- year 2007. The efficacy rates in this
study will incorporate the benefits of other elements in smoking cessation
programs, including counseling and behavioral modification. A previous
Phase II study which demonstrated up to a 40 percent quit rate in smokers
evaluated the vaccine-only benefits of NicVAX.
Cigarette Smoking: A Growing Global Health Challenge
Smoking is a global healthcare problem, and The World Health
Organization estimates that there are 1.3 billion smokers worldwide and
nearly five million tobacco-related deaths each year. According to the U.S.
Centers for Disease Control and Prevention (CDC), tobacco use is the single
leading preventable cause of death in the U.S. and is responsible for more
than 440,000 deaths each year. They estimate that approximately 70 - 80
percent of smokers in the U.S. want to quit, but less than five percent of
those who try to quit remain smoke-free at 12 months. In addition, they
estimate that smoking accounts for $167 billion in healthcare expenditures
and productivity losses each year.(1) To learn more about NicVAX and how it
works, please visit our Web site at:
http://www.nabi.com/pipeline/pipeline.php?id=3 .
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. The company has 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. Nabi
Biopharmaceuticals is focused on developing products that address unmet
medical needs and offer commercial opportunities in our core business
areas: Gram-positive bacterial infections, hepatitis and transplant, kidney
disease (nephrology) and nicotine addiction. For a complete list of
pipeline products, please go to: http://www.nabi.com/pipeline/index.php .
The company is headquartered in Boca Raton, Florida. For additional
information about Nabi Biopharmaceuticals, please visit our Web site at:
http://www.nabi.com .
Forward-Looking Statement
Statements in this press release about the company that are not
strictly historical are forward-looking statements and include statements
about our products in development, the market for such products, and
clinical trials and studies. You can identify these forward-looking
statements because they involve our expectations, beliefs, intentions,
plans, projections, or other characterizations of future events or
circumstances. These forward-looking statements are not guarantees of
future performance and are subject to risks and uncertainties that may
cause actual results to differ materially from those in the forward-looking
statements as a result of any number of factors. These factors include, but
are not limited to, risks relating to the company's ability to advance the
development of products currently in the pipeline or in clinical trials;
maintain the human and financial resources to commercialize current
products and bring to market products in development; obtain regulatory
approval for its products in the U.S., Europe or other markets;
successfully develop, manufacture and market its products; successfully
partner with other companies; realize future sales growth for its
biopharmaceutical products; maintain sufficient intellectual property
protection; raise additional capital on acceptable terms; and re-pay its
outstanding convertible senior notes when due. Many of these factors are
more fully discussed, as are other factors, in the company's Annual Report
on Form 10-K for the fiscal year ended December 31, 2005 and Quarterly
Report on Form 10-Q for the Quarter ended April 1, 2006 filed with the
Securities and Exchange Commission.
1. American Cancer Society, Cancer Prevention & Early Detection Facts &
Figures 2006. Atlanta: American Cancer Society, 2006. Centers for
Disease Control and Prevention. Annual smoking - attributable mortality,
years of potential life lost, and productivity losses - United States,
1997-2001. MMWR Morb Mortality Weekly Rep. 2005;54(25); 625:628.
SOURCE Nabi Biopharmaceuticals
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Related links:
http://www.nabi.com
http://www.nabi.com/pipeline/index.php
CONTACT:
Thomas E. Rathjen, Vice President, Investor
Relations, Nabi Biopharmaceuticals, +1-561-989-5800
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