Nabi Biopharmaceuticals Announces Participation In Phacilitate Vaccine Forum Munich 2007
06/04/07
Nabi
Biopharmaceuticals (Nasdaq: NABI) announced that the company will
participate in the Phacilitate Vaccine Forum Munich 2007 held from May 30 -
June 1, 2007 in Munich, Germany.
Dr. Dorothy Hatsukami, Forster Family Professor in Cancer Prevention
and Professor of Psychiatry at the University of Minnesota Tobacco Use
Research Center, will participate in a roundtable discussion and present
"Vaccination as an Aid to Smoking Cessation: Initial Results from a Phase
IIb Trial of NicVAX(R) (Nicotine Conjugate Vaccine)" at the conference at
12:15 p.m. local time on Friday, June 1, 2007.
Dr. Hatsukami will discuss the advantages of a vaccine approach to
smoking cessation and will outline key conclusions of the recently
announced Phase IIb trial:
-- NicVAX is well-tolerated
-- The NicVAX trial demonstrated a relationship between high antibody
titers and continued smoking abstinence at six months
-- NicVAX proof of concept was achieved in the trial
Per the Phacilitate conference guidelines, Dr. Hatsukami's presentation
will be available on the Nabi website after market close on June 1, 2007.
About the NicVAX Phase IIb Trial
The Phase IIb study is an ongoing double-blind, placebo-controlled and
dose-ranging study comprised of 301 patients and is designed to establish
proof of concept and the optimal dose for the Phase III 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. Full evaluation of abstinence at the six-month primary
endpoint will include 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,
antibody levels, safety and nicotine dependency.
About NicVAX and NIDA
In September 2005, the company 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.
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 one product on the market
today: Nabi-HB(R) [Hepatitis B Immune Globulin (Human)]. Nabi
Biopharmaceuticals is focused on developing products that address unmet
medical needs and offer commercial opportunities in our core business
areas: Hepatitis and transplant, Gram- positive bacterial infections and
nicotine addiction. The company recently announced that it intends to form
two strategic business units: Nabi Biologics and Nabi Pharmaceuticals. Nabi
Biologics will have responsibility for the company's protein and
immunological products and development pipeline, including Nabi-HB. Nabi
Pharmaceuticals will have responsibility for the NicVAX(R) (Nicotine
Conjugate Vaccine) and StaphVAX(R)-Pentavalent (Staphylococcal
Polysaccharide Conjugate and Toxoid Vaccine) development programs, as well
as for the continuing milestone-related clinical development obligations
following the sale of PhosLo(R) (calcium acetate). For a complete list of
pipeline products, please go to: