WILMINGTON, Del.–(BUSINESS WIRE)–Third paragraph, first sentence of release should read: Anthony Clarke,
Ph.D., Chief Scientific Officer of Extab, stated, “We are delighted to
have these positive Phase 3 clinical data reported…” (Instead of:
Anthony Clarke, Ph.D., Chief Scientific Officer of Extab, stated, “We
are delighted to have our positive Phase 3 clinical data reported …”)
The corrected release reads:
EXTAB CORPORATION ANNOUNCES POSITIVE DATA FROM PHASE 3 CLINICAL STUDY
OF CYTISINE AS A SMOKING CESSATION AID PUBLISHED IN THE NEW ENGLAND
JOURNAL OF MEDICINE
Shown to be superior to nicotine replacement therapy in study of
1,310 patients funded by the Health Research Council of New Zealand
Extab Corporation, a privately-held, pharmaceutical company
focused on advancing Tabex™, a smoking cessation drug containing the
active substance cytisine, announces that positive data from a Phase 3
clinical trial of cytisine as a smoking cessation aid were published in
the December 18 (Vol 271, No. 25) edition of The New England Journal
of Medicine (NEJM) in an article titled, “Cytisine versus Nicotine
for Smoking Cessation.” The complete article and a multi-media overview
of the study can be accessed on the home page of the NEJM website at www.nejm.org.
The Phase 3 clinical study (the “CASCAID” study) was a pragmatic,
open-label, noninferiority trial in which 1,310 adult daily smokers who
were motivated to quit and called the national quit-line were randomly
assigned in a 1:1 ratio to receive cytisine for 25 days or
nicotine-replacement therapy for 8 weeks. Cytisine was provided by mail,
free of charge, and nicotine-replacement therapy was provided through
vouchers for low-cost patches along with gum or lozenges. Low-intensity,
telephone-delivered behavioral support was provided to both groups
through the quit-line. The primary outcome was self-reported continuous
abstinence at one month. The study was conducted in New Zealand and was
funded by the Health Research Council of New Zealand.
Anthony Clarke, Ph.D., Chief Scientific Officer of Extab, stated, “We
are delighted to have these positive Phase 3 clinical data reported in
one of the world’s most prestigious peer-reviewed journals. This
large-scale Phase 3 trial in 1,310 patients comparing the efficacy of
cytisine against nicotine-replacement therapy demonstrated a superior
cytisine efficacy than nicotine-replacement therapy associated with an
excellent side-effect profile. The study authors suggest that cytisine
should be considered a cost-effective front-line treatment for tobacco
dependency that might help smokers quit smoking sooner, rather than
later.”
In an editorial from the December 2014 edition of NEJM titled, “A
Tobacco Treatment Hiding in Plain Sight,” Nancy A. Rigotti, M.D.,
Associate Chief, General Medicine Division Director, Tobacco Research
and Treatment Center at Massachusetts General Hospital in Boston, notes,
“The study reported here is noteworthy for its direct comparison of
cytisine with an established, first-line smoking-cessation
pharmacotherapy. In this randomized, noninferiority trial, cytisine was
not just similar to nicotine-replacement therapy but actually superior
to it for continuous tobacco abstinence at one month, the trial’s
primary outcome measure. This is only an end-of-treatment intermediate
outcome, but cytisine remained superior to nicotine-replacement therapy
at a 6-month follow-up in one of two typical measures of long-term
efficacy.”
The data showed that at one month, continuous abstinence from smoking
was reported for 40% of participants receiving cytisine (264 of 655) and
31% of participants receiving nicotine- replacement therapy (203 of
655), for a difference of 9.3 percentage points (95% confidence
interval, 4.2 to 14.5). The effectiveness of cytisine for continuous
abstinence was superior to that of nicotine-replacement therapy at one
week, two months, and six months. In a pre-specified subgroup analysis
of the primary outcome, cytisine was superior to nicotine-replacement
therapy among women and noninferior among men. Self-reported adverse
events over six months occurred more frequently in the cytisine group
(288 events among 204 participants) than in the group receiving
nicotine-replacement therapy (174 events among 134 participants).
Adverse events were primarily nausea and vomiting and sleep disorders.
Rick Stewart, Chairman and CEO of Extab, commented, “The positive
results of this real-life Phase 3 clinical trial are an excellent
endorsement of Tabex as a cost-effective treatment for smoking
cessation. Two large-scale Phase 3 clinical trials with over 2,000
patients treated have now been successfully conducted. Extab expects to
commence additional Phase 3 clinical trials in 2015 with a goal of
filing a New Drug Application with the U.S. Food and Drug Administration
and a Marketing Authorization Application with the European Medicines
Agency in late 2016.”
In addition to the positive results reported today, data from a
previously-conducted, 740-patient, double-blind, placebo-controlled
Phase 3 trial of Tabex as a treatment for smoking cessation (the “TASC”
study) were published in the “New England Journal of Medicine” (N
Engl J Med 2011; 365:1193-1200; September
29, 2011). These data showed a strong one-year quit rate result with
an Odds Ratio of 3.7 (p<0.001). Efficacy compared to placebo was
equivalent to leading prescription smoking cessation treatments with a
strong safety and side-effect profile with no neuropsychiatric issues.
The study concluded that Tabex is a cost-effective treatment with
potential to advance smoking cessation globally, especially among low-
and middle-income smokers who would like to quit but who cannot afford
the current smoking cessation options.
About Tabex
Tabex is a smoking cessation drug containing the active substance
cytisine, a quinolizidine alkaloid, derived from Laburnum
anagyroides (also known as Cytisus laburnum). Tabex
has been marketed in Central and Eastern Europe for many years as a
well-tolerated and effective treatment for smoking cessation. Over 20
million patients have been treated with Tabex and the latest Periodic
Safety Update Reports (PSUR) submitted to the European Medicines
Evaluation Agency (EMEA) was based on approximately 8 million cases.
Numerous Tabex clinical studies have demonstrated positive efficacy and
safety. There have been over 7,000 subjects in clinical trials to date.
The TASC and CASCAID studies are the first major studies to be performed
to Good Clinical Practice (GCP). The adverse effects associated with
Tabex treatment were generally mild and self-limiting; the benefit-risk
for Tabex treatment was excellent.
About Extab
Extab Corporation, a Delaware corporation, is a clinical stage
pharmaceutical company focused on the development of efficacious and
cost effective smoking cessation drugs. Extab is dedicated to seeking
regulatory approvals for Tabex in the U.S., Europe and Japan as well as
in developing countries.