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-- Further analysis of the six-month data has enabled Nabi to determine
both the therapeutic threshold at which quitting is first observed as
well as the target upper limit of antibody concentration.
-- In the nine-month data, NicVAX continues to demonstrate efficacy in
support of long-term smoking abstinence - the most effective NicVAX
dose regimen was 400 micrograms delivered in five injections over six
months. A statistically significant difference was seen when this
treated group was compared to placebo over time for the full Intent to
Treat (ITT) population:
-- Fixed 4-Week: NicVAX=24% (n=12/51); Placebo=14% (n=14/100) - p=0.14
-- Fixed 8-Week: NicVAX=20% (n=10/51); Placebo=13% (n=13/100) - p=0.29
-- Fixed 20-Week: NicVAX=20% (n=10/51); Placebo= 4% (n=4/100) -
p=0.0018
-- Fixed 34-Week: NicVAX=18% (n=9/51); Placebo=4% (n=4/100) - p=0.0047
-- To date, NicVAX continues its attractive safety trends with a
favorable adverse events profile comparable between placebo and each
dose group.
Recent Accomplishments
April:
-- Executed a definitive agreement to sell Aloprim(TM) (allopurinol
sodium) for Injection to Bioniche Teoranta for $3.7 million; the sale
was completed in May
May:
-- Established "proof of concept" for NicVAX in its Phase 2b clinical
trial, which met its primary endpoint of eight weeks of continuous
smoking abstinence between weeks 19-26
-- Participated in the Phacilitate Vaccine Forum Munich 2007, where
NicVAX principal investigator Dr. Dorothy Hatsukami, Forster Family
Professor in Cancer Prevention and Professor of Psychiatry at the
University of Minnesota Tobacco Use Research Center, discussed NicVAX
Phase 2b data in greater detail
June:
-- Formed the Nabi Bio
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SOURCE Nabi Biopharmaceuticals![]() Copyright©2007 PR Newswire. |