Press Release

NicOx' naproxcinod shows highly significant reduction in daytime blood pressure versus naproxen

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Posted 12 November 2008 @ 01:06 am ET

SOPHIA ANTIPOLIS, FRANCE -- (Marketwire) -- 11/12/08 -- New analysis of the 104 ABPM studypresented at the American Heart Association

November 12, 2008. Sophia Antipolis, France. www.nicox.com

NicOx S.A. (Euronext Paris: COX) today announced that a new analysis of thedata from the 104 Ambulatory Blood Pressure Monitoring (ABPM) study fornaproxcinod was presented yesterday at the American Heart AssociationScientific Sessions 2008, in New Orleans, USA. This ABPM pilot study inhypertensive volunteers was designed to compare the 24-hour blood pressureprofiles of naproxcinod 750 mg bid and naproxen 500 mg bid. Naproxcinod isNicOx' lead investigational product and the first compound in the newCyclooxygenase-Inhibiting Nitric Oxide-Donating (CINOD) class ofanti-inflammatory agents.

This new post hoc analysis was accepted by the American Heart Associationscientific panel and compared the mean 24-hour systolic blood pressure(SBP) as measured by ABPM in the two groups (i.e. naproxcinod vs.naproxen), at the end of the 2 weeks of active treatment. The mean 24-hourSBP showed a difference of 2.4 mmHg (standard error 0.87 mmHg) in favor ofnaproxcinod as compared to naproxen (p < > =0.007) after 2 weeks oftreatment. Interestingly, for the daytime measurements (the 8 hoursfollowing the morning dose), the mean 8-hour SBP showed a difference of 4.4mmHg (standard error 0.98 mmHg) in favor of naproxcinod as compared tonaproxen (p < 0.0001) after 2 weeks of treatment.

"It was very interesting and rewarding to share these promising resultswith the medical community at the American Heart Association ScientificSessions, which is one of the leading cardiology congresses worldwide,"commented Jacques Djian MD, Cardiologist and Vice-President TranslationalMedicine at NicOx. "This new analysis of the blood pressure data from the104 study follows the excellent top-line results we announced last week forthe 111 study. Both these ABPM trials suggest that naproxcinod's24&#8209;hour blood pressure profile is improved compared to naproxen's andwe are eager to receive the results of the ongoing 112 ABPM study in thecoming months."

The 104 trial was an 8-week, double-blind, randomized, cross-over study, inwhich 131 hypertensive volunteers between 50 and 75 years of age wereenrolled to receive either naproxcinod 750 mg bid for 2 weeks, followed bynaproxen 500 mg bid for 2 weeks, or these compounds in the reverse order.Subjects received a 2-week placebo wash&#8209;out at the beginning of thestudy and between the active treatment periods. Eligible subjects were notcurrent Non-Steroidal Anti-Inflammatory Drug (NSAID) users, had controlledhypertension, and could receive stable doses of up to 2 different classesof antihypertensive drugs.

NicOx is developing naproxcinod in late phase 3 clinical studies, which aredesigned to demonstrate that it is safe, well tolerated and effective fortreating the signs and symptoms of osteoarthritis, in addition to having nodetrimental effect on blood pressure, in contrast to traditional NSAIDs andCOX-2 inhibitors. The results of the third phase 3 trial for naproxcinod(the 303 study) are expected before the end of the year and the filing of aNew Drug Application (NDA) for naproxcinod with the U.S. Food and DrugAdministration (FDA) is projected for mid&#8209;2009.

NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) a product-drivenbiopharmaceutical company dedicated to the development and futurecommercialization of investigational drugs for unmet medical needs. NicOxis applying its proprietary nitric oxide-donating technology to develop aninternal portfolio of New Chemical Entities (NCEs) in the therapeutic areasof inflammatory and cardio-metabolic disease.

Resources are focused on the development of naproxcinod, a proprietary NCEand the first compound in the Cyclooxygenase-Inhibiting NitricOxide-Donating (CINOD) class of anti-inflammatory agents, which is in phase3 clinical studies for the treatment of the signs and symptoms ofosteoarthritis, with final phase 3 results anticipated in 2008.

Beyond naproxcinod, NicOx has a pipeline containing multiple nitricoxide-donating NCEs, which are in development internally and with partners,including Pfizer Inc and Merck & Co., Inc., for the treatment of prevalentand underserved diseases, such as atherosclerosis, hypertension, widespreadeye diseases and Chronic Obstructive Pulmonary Disease (COPD).

NicOx S.A. is headquartered in France and is listed on the Euronext ParisStock Exchange (Compartment B: Mid Caps).

This press release contains certain forward-looking statements. Althoughthe Company believes its expectations are based on reasonable assumptions,these forward-looking statements are subject to numerous risks anduncertainties, which could cause actual results to differ materially fromthose anticipated in the forward-looking statements. For a discussion ofrisks and uncertainties which could cause actual results, financialcondition, performance or achievements of NicOx S.A. to differ from thosecontained in the forward-looking statements, please refer to the RiskFactors ("Facteurs de Risque") section of the Document de Reference filedwith 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.com

NicOx: Karl Hanks Director of Investor Relations and CorporateCommunication

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

Nina Enegren - Tel +44 (0)207 282 1050 - nina.enegren@citigatedr.co.uk

NicOx S.A.,

Les Taissounières - Bât HB4 - 1681 route des Dolines - BP313, 06906 SophiaAntipolis cedex, France. Tel. +33 (0)4 97 24 53 00 - Fax +33 (0)4 97 24 5399

This information is provided by HUGIN


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