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Initiates Second Phase 3
Study to Confirm Naproxcinod's Efficacy and Improved Blood Pressure
France, April 3 /PRNewswire
NicOx S.A. (Eurolist: COX) today announced
that it has initiated the second pivotal phase 3 trial for naproxcinod
in patients with osteoarthritis of the knee (the 302 study). The trial
is expected to enroll approximately 1020 patients at around 120
clinical centers in the United States. The objective of the study is to
confirm naproxcinod's efficacy and provide additional blood pressure
data, a key factor to differentiate naproxcinod from existing
treatments. Efficacy results are expected in mid-2008.
Garufi, Chairman and CEO of NicOx, declared: "The initiation of this
second pivotal phase 3 trial is in line with our development plan for
naproxcinod, which foresees the filing of a New Drug Application in the
US during the first quarter of 2009. Based upon the recent positive
results from the first phase 3 trial and from the ABPM trial, we at
NicOx continue to dedicate our resources to proving that naproxcinod is
an innovative and unique drug for the treatment of the signs and
symptoms of osteoarthritis. Naproxcinod represents the driving force
for NicOx' transformation into an integrated pharmaceutical company."
is the first compound in the COX-Inhibiting Nitric Oxide- Donating
(CINOD) class, which NicOx aims to develop as the drug-of-choice for
treating the signs and symptoms of osteoarthritis. The initiation of
302 follows the successful results obtained for naproxcinod in previous
phase 2 and phase 3 trials (see press releases of October 27, 2006, and
December 20, 2005), which showed superior efficacy to placebo and no
detrimental effect on blood pressure, when compared to existing
non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs represent an
established symptomatic treatment for the millions of patients who
suffer from osteoarthritis. However, these widely used products are
associated with worrying side effects, including the tendency to raise
blood pressure to an extent that may increase the rate of
cardiovascular adverse events.
endpoints of the 302 study
study is a 53-week, randomized, double-blind, efficacy and safety trial
in patients with osteoarthritis of the knee. Eligible patients will be
randomized to one of the following treatment groups: naproxcinod 375 mg
bid (52 weeks), naproxcinod 750 mg bid (52 weeks), naproxen 500 mg bid
(52 weeks) and placebo bid during the first 13 weeks. After 13 weeks,
the placebo treated patients will be randomized to either naproxcinod
375 mg bid or naproxcinod 750 mg bid for the remainder of the trial (39
patients should have primary osteoarthritis of the knee of at least 3
months duration. The trial will recruit both hypertensive and non-
hypertensive patients, although patients with uncontrolled hypertension
will be excluded.
doses of naproxcinod will be compared to placebo on three co- primary
efficacy endpoints, based on the mean change between baseline and
week-13 in the following scores: the WOMAC(TM) pain subscale, the
WOMAC(TM) function subscale and subject's overall rating of disease
status. These are the standard endpoints used to demonstrate the
efficacy of drugs for treating the signs and symptoms of osteoarthritis
and are the same as those used in the 301 study.
secondary endpoint of the trial will compare the efficacy of
naproxcinod and naproxen at 26 weeks. The general safety and
tolerability of naproxcinod will be assessed until week-52 and the
trial will have a 1-week post-treatment safety period.
pressure monitoring and endpoints
As in the 301
study, patients' blood
pressure will be assessed during each visit to the treatment center,
using controlled Office Blood Pressure Measurements (OBPM - see NOTE).
The blood pressure effect of naproxcinod will be assessed in two groups
of patients: the overall population and a sub-group of hypertensive
subjects. Various blood pressure endpoints will compare the different
treatments in terms of the mean change from baseline in systolic and
diastolic blood pressure, at a range of time points. Additional blood
pressure endpoints will assess the appearance of new hypertension or
worsening of pre- existing hypertension.
plans to initiate a third phase 3 trial (the 303 study) in the first
half of 2007, which will assess naproxcinod's efficacy and safety in
patients with osteoarthritis of the hip. In addition, the Company will
conduct a predefined statistical analysis on the pooled OBPM data from
the three phase 3 studies (301, 302 and 303).
Stromberg, Vice President of Drug Development at NicOx and Project Team
Leader for naproxcinod, added: "Based on phase 2 and 3 data, we are
very confident about the safety and efficacy profile of naproxcinod.
This second phase 3 study will provide additional safety and efficacy
data for regulatory filing, as well as giving us the opportunity to
statistically test naproxcinod's improved blood pressure profile, by
pooling its data with the other phase 3 trials. Reducing the
cardiovascular risk of NSAID users is very important and we believe
that the potentially improved blood pressure profile of naproxcinod
will be a key differentiating factor in the anti-inflammatory drug
Office Blood Pressure Measurements (OBPM) are made by a health care
professional during a patient's visit to the treatment center using
standard equipment (i.e. a sphygmomanometer). OBPM will be performed in
the morning and the time between intake of study-drug and measurement
of OBPM should be between 2 and 4 hours. Systolic blood pressure is the
maximum pressure in the arteries when the heart is contracting, while
diastolic pressure is the lowest pressure between heart beats.
(Bloomberg : COX : FP, Reuters : NCOX.PA) is a product-driven
biopharmaceutical company dedicated to the development of nitric oxide-
donating drugs to meet unmet medical needs. NicOx is targeting the
therapeutic areas of pain and inflammation and cardio-metabolic
disease. Resources are focused on two lead compounds, naproxcinod
(formerly HCT 3012); in phase 3 development for the treatment of signs
and symptoms of osteoarthritis, and NCX 4016, in phase 2 for type 2
strategic partnerships with some of the world's leading pharmaceutical
companies, including Pfizer Inc and Merck & Co., Inc.
is headquartered in Sophia-Antipolis, France, and is listed on the
Eurolist of Euronext(TM) Paris (segment: Next Economy).
elements included in this communication may contain forward-looking
statements subject to certain risks and uncertainties. Actual results
of the company may differ materially from those indicated in the
forward-looking statements because of different risks factors described
in the company's document de reference.
http://www.nicox.com/ NicOx Karl Hanks Manager of Corporate Relations
and Market Analysis Tel +33 (0)4 97 24 53 42 firstname.lastname@example.org Investors
in the United States Burns McClellan Lisa Burns email@example.com
Laura Siino firstname.lastname@example.org Tel +1 212 213 0006 Media FD Jonathan
Birt Tel +1 212 850 56 34 email@example.com
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