SOPHIA ANTIPOLIS, FRANCE -- 07/22/08 --
www.nicox.com
NicOx S.A. (Euronext Paris: COX) today announced it has successfully
completed the enrollment of 417 osteoarthritis (OA) patients with
controlled hypertension in two clinical pharmacology studies in the United
States, in line with previously announced timelines. These trials are
designed to assess the blood pressure profile of naproxcinod, in comparison
to ibuprofen and naproxen, using the Ambulatory Blood Pressure Monitoring
(ABPM) technique. Results of both studies are expected in Q4 2008.
Naproxcinod is NicOx' lead investigational drug and the first compound in
the Cyclooxygenase-Inhibiting Nitric Oxide-Donating (CINOD) class of anti-
inflammatory agents, which is currently in phase 3 clinical development for
the treatment of the signs and symptoms of OA, with results of the last two
phase 3 studies anticipated in the second half of 2008.
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), such as ibuprofen and
naproxen, are commonly used by OA patients to control their chronic pain,
inflammation and stiffness. However, these important products have the
tendency to raise blood pressure, a side effect of particular concern in OA
patients due to the high prevalence of hypertension and other
cardiovascular risk factors in this elderly population.
The objectives of these phase 1 ABPM trials, known as the 111 and 112
studies, are to provide important additional data on the 24-hour blood
pressure profile of naproxcinod in chronically treated OA patients with
controlled hypertension, in comparison to commonly used NSAIDs. The 111 is
a 12-week study, which has enrolled 118 patients at 30 clinical sites, who
are receiving increasing doses of either naproxcinod or naproxen at three
week intervals. The 112 study has enrolled 299 patients at 60 clinical
sites, which have been randomized to five groups, receiving 13 weeks of
treatment with: naproxcinod 375 mg bid (twice daily), naproxcinod 750 mg
bid, naproxen 250 mg bid, naproxen 500 mg bid or ibuprofen 600 mg tid
(three times daily).
The data from the 111 and 112 studies will complement the results of a 2-
week ABPM study with naproxcinod compared to naproxen in hypertensive
volunteers (the 104 study), which were presented at the American Heart
Association (AHA) in November 2007. They will also complement the Office
Blood Pressure Measurements (OBPMs) being collected in each of the pivotal
phase 3 OA studies (including the completed 301 study and the ongoing 302
and 303 studies).
Maarten Beekman, Vice President of Clinical Development and Medical Affairs
at NicOx commented: "We are very pleased to have fully enrolled these two
clinical pharmacology studies and we look forward to their results in the
fourth quarter of this year. We believe the timely achievement of this
milestone is a testament to the strength of the clinical team we have
assembled at NicOx and also reflects the interest of clinical centers and
patients in naproxcinod."
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). CONTACTS:
http://www.nicox.comNicOx: Karl Hanks - Director of Investor Relations and
Corporate Communication - Tel +33 (0)4 97 24 53 42 - hanks@nicox.com
Media in the United States - FD - Robert Stanislaro - Tel +1 212 850 5657 -
robert.stanislaro@fd.com
Irma Gomez-Dib - Tel +1 212 850 5761 - irma.gomez-dib@fd.com
Media in Europe - Citigate Dewe Rogerson: David Dible - Tel +44 (0)207 282
2949 - david.dible@citigatedr.co.uk
Sylvie Berrebi - Tel +44 (0)207 282 1050 -sylvie.berrebi@citigatedr.co.uk
NicOx S.A.,
Les Taissounières - Bât HB4 - 1681 route des Dolines - BP313, 06906 Sophia
Antipolis cedex, France. Tel. +33 (0)4 97 24 53 00 - Fax +33 (0)4 97 24 53
99
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