NicVAX Supports Statistically Significant Point Prevalence and Continuous
Abstinence by Dose, Schedule and Antibody Response; Nabi to Host Conference
Call Today
BOCA RATON, Fla., Sept. 5 /PRNewswire-FirstCall/ -- Nabi
Biopharmaceuticals (Nasdaq: NABI) today announced nine-month data from its
ongoing trial of NicVAX(R) (Nicotine Conjugate Vaccine), the company's
innovative and proprietary investigational vaccine being developed to treat
nicotine addiction and prevent smoking relapse. These nine-month data
demonstrate NicVAX efficacy in supporting statistically significant and
continuous abstinence rates by dose as well as by antibody response. The
nine-month data also have enabled Nabi to determine what it believes is the
most effective dose and schedule for NicVAX and determine the antibody
concentration threshold for clinical efficacy. In May 2007, Nabi announced
this trial's six-month data -- a statistically significant number of
patients with a high anti-nicotine antibody response met the trial's
primary endpoint of eight weeks of continuous abstinence between weeks
19-26.
NicVAX Nine-Month Data Key Findings
-- High antibody responders (top 30%) continued to show statistically
significant abstinence at nine months:
-- 9-Month continuous abstinence rate: NicVAX=20% (12/61, p=0.0076) vs.
Placebo=6% (6/100)
-- Statistically significant dose response observed for continuous
abstinence at six and nine months for Schedule 2, 200 and 400 microgram
doses in the intent to treat population:
-- 9-Month continuous abstinence: NicVAX 400 micrograms =18% (9/51,
p=0.0047), Placebo=4% (4/100)
-- 9-Month continuous abstinence: NicVAX 200 micrograms =14% (7/50,
p=0.027), Placebo=4% (4/100)
-- Most effective schedule selected: Schedule 2 (five injections over six
months)
-- Most effective dose selected: 400 micrograms
-- Threshold antibody level identified and probability of abstinence vs.
antibody levels calculated:
-- Attainment of the antibody threshold at Target Quit Date determines
chronic abstinence
-- Subjects in the therapeutic effect window have a >50% likelihood of
quitting
-- No compensatory smoking or increase in withdrawal symptoms
-- Through the nine months of the Phase 2b trial, NicVAX continues its
attractive safety trends with a favorable adverse events profile and no
difference between placebo and each dose group.
"We are extremely pleased with the NicVAX data and the continued
smoking cessation trends we've observed through nine months of this
clinical trial," said Dr. Leslie Hudson, Interim President and Chief
Executive Officer of Nabi. "Our latest analyses have helped us identify a
NicVAX dose that achieves the high antibody levels associated with helping
smokers successfully quit smoking and remain abstinent over long periods of
time. These analyses have also provided us with data that are extremely
important for our ongoing partnering efforts. We believe the full 12-month
data will be invaluable as we determine next steps for our clinical
development program."
To gain greater perspective on these data, Nabi discussed its
nine-month findings with nationally recognized smoking cessation
researchers and the National Institute on Drug Abuse (NIDA). Nabi will use
these validated and promising nine-month data to advance its partnership
discussions surrounding NicVAX.
"The data seen to-date for NicVAX have been extremely encouraging,"
said Dr. Dorothy Hatsukami, Forster Family Professor in Cancer Prevention
and Professor of Psychiatry at the University of Minnesota Tobacco Use
Research Center. "The data show that there is an observable link between
the high antibody levels achieved with the 400 microgram NicVAX dosing
regimen and the ability of these patients to quit smoking and to remain
abstinent. This key development -- the success of a smoking cessation
vaccine -- could have an important impact on how we address smoking and
smoking relapse."
Nabi will discuss and present these nine-month data in further detail
at several upcoming scientific and investor conferences. Nabi is scheduled
to participate in the Biennial Conference of the California Tobacco-Related
Disease Research Program, Oct. 8-9, 2007 in Sacramento, California.
Additionally, Dr. Dorothy Hatsukami is scheduled to present NicVAX findings
at the 9th European Society for Research on Nicotine and Tobacco (SRNT)
Europe conference, October 3-6, 2007 in Madrid, Spain. Dr. Leslie Hudson is
also slated to present on Sept. 6, 2007 at the Thomas Weisel Partners
Healthcare Conference in Boston and on Sept. 11, 2007 at the Bear Stearns
Healthcare Conference in New York. Additionally, the full twelve-month
NicVAX data have been accepted for presentation at the American Heart
Association (AHA) Scientific Sessions 2007 in Orlando, Florida on November
7, 2007.
Conference Call
Nabi will host a live webcast at 5:30 p.m. EDT today, September 5, to
discuss these nine-month data. Additionally, presentation slides
highlighting key data points will be made available immediately prior to
today's call. These slides can be accessed at http://www.nabi.com.
The live webcast can be accessed at:
http://phx.corporate-ir.net/phoenix.zhtml?p=irol-
eventDetails&c=100445&eventID=1641393
or via the Nabi Biopharmaceuticals website at http://www.nabi.com.
If you do not have Internet access, the U.S./Canada call-in number is
(866) 713-8307 and the international call-in number is (617) 597-5307. The
participant passcode is 42339034. An audio replay will be available for
U.S./Canada callers at (888) 286-8010 and for international callers at
(617) 801-6888. The participant passcode is 67358690.
An archived version of the webcast will be available at the same
Internet address through September 12, 2007. The audio replay also will be
available through September 12, 2007. The press release will be available
on the company's website at http://www.nabi.com.
About the Phase 2b Study
The Phase 2b study is a double-blind, placebo-controlled and
dose-ranging study comprised of 301 patients designed to establish proof of
concept and the optimal dose for the Phase 3 program. This study was
designed in collaboration with the U.S. Food and Drug Administration and
other global regulatory agencies and incorporates the most current clinical
trial standards and prevailing protocol design for smoking cessation
studies. The trial's primary endpoint is the rate of carbon monoxide
(CO)-confirmed, continuous abstinence from smoking during weeks 19-26 after
first vaccination.
About NicVAX
NicVAX is an innovative and proprietary investigational vaccine being
developed by Nabi to treat nicotine addiction and prevent smoking relapse.
NicVAX is designed to stimulate the immune system to produce antibodies
that bind to nicotine. A nicotine molecule attached to an antibody is too
large to cross the blood-brain barrier. Therefore, NicVAX blocks nicotine
from reaching its receptors in the brain and prevents the highly-addictive
pleasure sensation experienced by smokers and users of nicotine products.
Pre-clinical and previous clinical data, as well as the study reported
here, show that NicVAX's ability to block nicotine from reaching the brain
could help people quit smoking. Because the body's immune system can be
boosted to produce long-lasting antibodies, Nabi believes NicVAX also could
be effective in preventing smoking relapse. Relapse is a significant
challenge facing smokers and, with currently-available smoking cessation
therapies, relapse rates can be as high as 90% in the first year after a
smoker quits.
NicVAX Development Progress to Date
In September 2005, Nabi announced that it received a $4.1 million grant
from the National Institute on Drug Abuse (NIDA), which is part of the
National Institutes of Health. NIDA has also funded, in part, the costs for
toxicology testing and earlier clinical trials in the U.S. and contributed
scientific and clinical expertise to the program overall. 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. Nabi
Biopharmaceuticals' intellectual property portfolio for technology related
to NicVAX includes both issued and pending patents in the U.S. In addition,
Nabi holds granted patents in 18 European countries, plus patents and
pending patent applications in numerous other countries around the world.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in
powering the immune system to develop and, in certain areas, market
products that target serious medical conditions in the areas of hepatitis
and transplants, gram positive bacterial infections and nicotine addiction.
We are a vertically integrated company with sales of antibodies and other
biologics, including Nabi-HB(R) [Hepatitis B Immune Globulin (Human)], a
pipeline of products in various stages of development and a
state-of-the-art manufacturing capability. The company operates through two
strategic business units: Nabi Biologics and Nabi Pharmaceuticals. Nabi
Biologics has responsibility for the company's protein and immunological
products and development pipeline, including Nabi- HB. Nabi Pharmaceuticals
is responsible for the NicVAX(R) (Nicotine Conjugate Vaccine) and
StaphVAX(R) (Staphylococcus aureus Polysaccharide Conjugate Vaccine)
development programs. 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: http://www.nabi.com.
Forward-Looking Statements
Statements in this release that are not strictly historical are
forward- looking statements and include statements about reorganization of
our current business into two new business units, our strategic
alternatives process and clinical trials and studies. You can identify
these forward-looking statements because they involve our expectations,
beliefs, projections, anticipations 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 our ability to:
successfully continue development of our pipeline products, including
NicVAX; obtain successful clinical trial results; successfully partner with
third parties to fund, develop, manufacture and/or distribute our existing
and pipeline products, including NicVAX and our Gram-positive infections
products; our ability to successfully complete our strategic alternatives
process; realize anticipated cost savings related to job elimination due to
greater than anticipated severance-related costs or other factors; generate
sufficient cash flow from sales of products or from milestone or royalty
payments to fund our development and commercialization activities; attract
and maintain the human and financial resources to commercialize current
products and bring to market products in development; depend upon third
parties to manufacture or fill our products; achieve approval and market
acceptance of our products; expand our sales and marketing capabilities or
enter into and maintain arrangements with third parties to market and sell
our products; effectively and/or profitability use, or utilize the full
capacity of, our vaccine manufacturing facility; manufacture NicVAX or
other products in our own vaccine manufacturing facility; comply with
reporting and payment obligations under government rebate and pricing
programs; raise additional capital on acceptable terms, or at all; and
re-pay our 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, 2006 and
our Quarterly Report for the quarter ended June 30, 2007 on Form 10-Q with
the Securities and Exchange Commission.
SOURCE Nabi Biopharmaceuticals
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Related links:
http://www.nabi.com
http://www.nabi.com/pipeline/index.php
CONTACT:
Investor Relations, Nabi Biopharmaceuticals,
+1-561-989-5800
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