NicOx Provides an Update on NCX 4016
June 18 2007 - 7:00AM
PR Newswire (US)
SOPHIA ANTIPOLIS, France, June 18 /PRNewswire-FirstCall/ -- NicOx
S.A. (Eurolist: COX) today announced that NicOx and the US National
Cancer Institute (NCI) have agreed to end an NCI-sponsored phase 1
trial studying the potential of NCX 4016 as a preventative
treatment for colon cancer. The decision is a precautionary measure
due to results observed in non- clinical, in vitro genotoxicity
tests on NCX 4015, a potential, specific metabolite of NCX 4016.
NicOx is in the process of evaluating a further program of testing
in order to assess the relevance of these results. NicOx has
successfully completed the full range of genotoxicity tests
recommended by international guidelines for all the clinical
development candidates in its pipeline, including NCX 4016. The
recent results from in vitro genotoxicity tests on NCX 4015 are not
in-line with the results of these earlier tests on NCX 4016 and
with an in vivo test suggesting no genotoxicity with NCX 4015. NCX
4015 may be a metabolite of NCX 4016 but cannot be a metabolite of
other compounds in NicOx' portfolio, due to its distinct chemical
structure, and therefore NicOx' other portfolio programs, including
the development of naproxcinod and the programs with Merck &
Co., Inc. and Pfizer Inc, will not be affected. The Company will
delay the start of planned phase 2 studies of NCX 4016 in type 2
diabetes pending the completion of additional testing on NCX 4015.
NicOx (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 the signs and symptoms of osteoarthritis, and
NCX 4016, in phase 2 for type 2 diabetes. NicOx has strategic
partnerships with some of the world's leading pharmaceutical
companies, including Pfizer Inc. and Merck and Co., Inc. NicOx S.A.
is headquartered in Sophia-Antipolis, France, and is a public
company listed on the Eurolist of Euronext(TM) Paris (segment: Next
Economy). The 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. CONTACTS: http://www.nicox.com/ NicOx: Karl Hanks -
Manager of Corporate Relations and Market Analysis - Tel +33 (0)4
97 24 53 42 - Investors in the United States - Burns McClellan:
Lisa Burns - , Laura Siino - - Tel +1 212 213 0006 Media in the
United States - FD - Jonathan Birt - Tel +1 212 850 56 34 - Media
in Europe - Citigate Dewe Rogerson: Valerie Auffray - Tel: +44
(0)207 282 2979 - , David Dible - Tel +44 (0)207 282 2949 -
DATASOURCE: NicOx S.A. CONTACT: Karl Hanks of NicOx, Manager of
Corporate Relations and Market Analysis, +33 (0)4 97 24 53 42, ;
Investors in the United States, Lisa Burns, , or Laura Siino, ,
+1-212-213-0006, both of Burns McClellan; Media in the United
States, Jonathan Birt of FD, +1-212-850-5634, ; Media in Europe,
Valerie Auffray, +44 (0)207 282 2979, , or David Dible, +44 (0)207
282 2949, , both of Citigate Dewe Rogerson Web site:
http://www.nicox.com/
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