NicOx Completes Patient Enrollment in Third Naproxcinod Pivotal Phase 3 Study
May 28 2008 - 7:00AM
PR Newswire (US)
SOPHIA ANTIPOLIS, France, May 28 /PRNewswire-FirstCall/ -- NicOx
S.A. (Euronext Paris: COX) today announced the completion of
patient enrollment in the third pivotal phase 3 clinical trial for
naproxcinod, in patients with osteoarthritis of the hip (the 303
study). 810 patients have been randomized in 120 clinical centers
in North America and Europe in this study, which is the final phase
3 trial in NicOx' clinical plan for the regulatory filing of
naproxcinod. The objective of this study is to assess naproxcinod's
efficacy in relieving the signs and symptoms of osteoarthritis of
the hip and provide additional safety data, including further
information on naproxcinod's blood pressure profile in comparison
to another anti-inflammatory medication. Results from this study
are expected in Q4 2008 and NicOx projects the filing of a New Drug
Application (NDA) in mid-2009. NicOx is currently in the final
stages of developing naproxcinod as an investigational drug for
treating the signs and symptoms of osteoarthritis. Naproxcinod is
the most advanced compound in a novel class of anti-inflammatory
agents known as the Cyclooxygenase-Inhibiting Nitric Oxide Donators
(CINODs). The 303 study follows the previous two pivotal phase 3
trials. Successful results were obtained in the 301 phase 3 study,
in patients with osteoarthritis of the knee (see press release of
October 27, 2006). These data demonstrated superior efficacy to
placebo. Data collected suggested that naproxcinod could have no
detrimental effect on blood pressure, in contrast to naproxen, a
widely used non-steroidal anti-inflammatory drug (NSAID). NSAIDs
are known to have the tendency to elevate blood pressure to an
extent that may increase the rate of serious cardiovascular adverse
events, such as heart attack and stroke. The 302 study for
naproxcinod in patients with osteoarthritis of the knee (see press
release of April 3, 2007) is due to report results in Q3 2008.
Maarten Beekman, Vice President of Clinical Development at NicOx,
commented: "The completion of patient enrollment in this pivotal
phase 3 trial for naproxcinod is a further important step in our
plan for the regulatory filing of the first CINOD in the US and
Europe. The enrollment of 810 hip osteoarthritis patients in less
than a year is a significant achievement, due to the lower
availability of these patients for clinical studies and the strict
protocol criteria necessary for this study. Medical literature from
other anti-inflammatory agents shows that hip osteoarthritis
studies have produced a lower rate of positive efficacy results
than knee studies. Nevertheless, we believe the stringent criteria
applied to the 303 study give us a good probability of achieving a
positive result on the primary endpoint." Trial design and
endpoints of the 303 study The 303 study is a 13-week,
double-blind, placebo and naproxen controlled trial in patients
with osteoarthritis of the hip. 810 patients have been randomized
at 120 clinical centers in the United States, Canada and several
European countries. Eligible patients had a diagnosis of primary
osteoarthritis of the hip of at least three months in duration and
were randomized to three arms: naproxcinod 750 mg bid, placebo bid
and naproxen 500 mg bid. Three co-primary endpoints are being used
to compare the efficacy of naproxcinod to placebo, 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
the 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 the same as
those used in the 301 and 302 trials. The 303 study is powered to
show statistical significance for the superiority of naproxcinod
over placebo at 13 weeks on the three co-primary endpoints. In
addition, other variables will be measured in order to assess the
general safety and tolerability of naproxcinod. As in the 301 and
302 studies, patients are undergoing standardized blood pressure
measurements at each visit to the clinical center (Office Blood
Pressure Measurements, OBPM - see NOTE). NicOx will conduct a
predefined statistical analysis on the pooled OBPM data from the
phase 3 studies and the results of this analysis are expected in Q4
2008. NOTE: Office Blood Pressure Measurements (OBPM) are performed
by a health care professional during a patient's visit to the
clinical center using standard, calibrated equipment (i.e. a
sphygmomanometer). OBPM measurements are being performed in the
morning and the time between intake of study-drug and measurement
of OBPM should be between 2 and 4 hours. NicOx (Bloomberg: COX:FP,
Reuters: NCOX.PA) a product-driven biopharmaceutical company
dedicated to the development and future commercialization of
investigational drugs for unmet medical needs. NicOx is applying
its proprietary nitric oxide-donating technology to develop an
internal portfolio of New Chemical Entities (NCEs) in the
therapeutic areas of inflammatory and cardio-metabolic disease.
Resources are focused on the development of naproxcinod, a
proprietary NCE and the first compound in the
Cyclooxygenase-Inhibiting Nitric Oxide-Donating (CINOD) class of
anti-inflammatory agents, which is in phase 3 clinical studies for
the treatment of the signs and symptoms of osteoarthritis, with
final phase 3 results anticipated in 2008. Beyond naproxcinod,
NicOx has a pipeline containing multiple nitric oxide-donating
NCEs, which are in development internally and with partners,
including Pfizer Inc and Merck & Co., Inc., for the treatment
of prevalent and underserved diseases, such as atherosclerosis,
hypertension, glaucoma and Chronic Obstructive Pulmonary Disease
(COPD). NicOx S.A. is headquartered in France and is listed on the
Euronext Paris Stock Exchange (Compartment B: Mid Caps). This press
release contains certain forward-looking statements. Although the
Company believes its expectations are based on reasonable
assumptions, these forward-looking statements are subject to
numerous risks and uncertainties, which could cause actual results
to differ materially from those anticipated in the forward-looking
statements. For a discussion of risks and uncertainties which could
cause actual results, financial condition, performance or
achievements of NicOx S.A. to differ from those contained in the
forward-looking statements, please refer to the Risk Factors
("Facteurs de Risque") section of the Document de Reference filed
with the AMF, which is available on the AMF website
(http://www.amf-france.org/) or on NicOx S.A.'s website
(http://www.nicox.com/). DATASOURCE: NicOx S.A. CONTACT: Karl
Hanks, Director of Investor Relations and Corporate Communication,
NicOx, +33 (0)4 97 24 53 42, , Investors in the United States -
Burns McClellan, Lisa Burns, , or, Juliane Snowden,
+1-212-213-0006, ; Media in the United States - FD - Jonathan Birt,
+1-212-850-5634, ; Media in Europe - Citigate Dewe Rogerson, David
Dible, +44 (0)207 282 2949, , or, Sylvie Berrebi, +44 (0)207 282
1050, Web site: http://www.nicox.com/ http://www.amf-france.org/
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