NicOx Completes Patient Enrollment In Third Naproxcinod Pivotal Phase 3 Study
(Euronext Paris: COX) 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
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
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
NicOx completeaza pacientului de înscriere În al treilea rând Naproxcinod pivot de fazã 3 de studiu - NicOx Completes Patient Enrollment In Third Naproxcinod Pivotal Phase 3 Study - articole medicale engleza - startsanatate