Nabi Biopharmaceuticals Initiates Phase IIB "Proof-of-Concept" Study For NicVAX
24 Maio 2006 - 6:34PM
PR Newswire (US)
- 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.
DATASOURCE: Nabi Biopharmaceuticals CONTACT: Thomas E. Rathjen,
Vice President, Investor Relations, Nabi Biopharmaceuticals,
+1-561-989-5800 Web site: http://www.nabi.com/
http://www.nabi.com/pipeline/index.php
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