NicOx
SOPHIA ANTIPOLIS, FRANCE--(Marketwire - January 3, 2008) -
www.nicox.com
NicOx S.A. (Euronext Paris: COX) today announced that Pfizer Inc has initiated a dose-ranging phase 2 clinical study for PF-03187207 in
Japan. PF-03187207 is a new experimental medicine for the treatment of
glaucoma, which is currently in an ongoing phase 2 proof-of-concept study
in the United States (see press releases of March 28 and 29, 2007).
Glaucoma and ocular hypertension are a group of severe eye diseases that
can lead to blindness and this new Japanese study will compare the safety
and efficacy of PF-03187207 to Xalatan® (latanoprost) in Japanese
patients with these conditions. Xalatan® is a proprietary Pfizer product
and the leader in worldwide glaucoma sales, with approximately $1.5 billion
of franchise sales in 2006.
PF-03187207 is the lead development compound generated under the August
2004 collaboration agreement between Pfizer and NicOx, which focuses on the
research and development of nitric oxide-donating prostaglandin F2-alpha
analogs for the treatment of glaucoma (see NOTE).
Maarten Beekman, Vice President of Clinical Development at NicOx, said: "We
believe the initiation of this separate Japanese study for PF-03187207
highlights Pfizer's determination to rapidly advance this clinical program
towards coordinated regulatory filing in the world's major pharmaceutical
markets. Preclinical results have suggested that NicOx' technology has the
potential to deliver improved treatments for glaucoma and we look forward
to the results of the ongoing proof-of-concept phase 2 study for
PF-03187207 in the United States."
Design and rationale for the study
The first clinical study for PF-03187207, initiated in March 2007 in the
United States, is a phase 2 proof-of-concept study that aims to compare the
safety and efficacy of PF-03187207 to Xalatan® in terms of intraocular
pressure lowering (IOP, pressure within the eye). The new phase 2 trial is
similar in design to the U.S. study, except that it will be conducted in
Japan, initiating the program for registration there. PF-03187207 has the
potential to have an increased capacity to reduce high IOP relative to
currently marketed agents. The development of abnormally high IOP, due to
blockage or malfunction of systems controlling the amount of fluid in the
eye, is believed to be one of the principal causes of glaucoma.
The new Japanese trial is a 28 day, double-masked, dose-ranging study, in
which approximately 120 Japanese patients with primary open-angle glaucoma
or ocular hypertension, in one or both eyes, will be randomized to
treatment groups that will receive different doses of PF-03187207 or
Xalatan®. The objective of the study is to investigate the dose response,
safety and efficacy of PF-03187207 in this patient population. The primary
endpoint is the reduction in IOP at day 28, compared to baseline. Secondary
endpoints will include safety assessments and the IOP on days 14 and 28, as
well as the proportion of patients attaining target IOP or less at each of
the study visits.
NOTE: Glaucoma is a group of eye diseases which can lead to the loss of
peripheral vision and eventually total blindness. The disease is frequently
linked to abnormally high pressure in the eye (IOP), due to blockage or
malfunction of the eye's drainage systems. Abnormally high IOP does not
cause any symptoms itself, however it can lead to vision loss. The most
common form of the disease is primary open-angle glaucoma. Drug therapy is
used to reduce IOP and therefore prevent further vision loss, typically
through increasing the drainage of intraocular fluid by relaxing certain
muscles in the eye.
NicOx (Bloomberg: COX:FP, Reuters: NCOX.PA) is a product-driven
biopharmaceutical company dedicated to the development of investigational
nitric oxide-donating drugs to meet unmet medical needs. NicOx is targeting
the therapeutic areas of inflammation and cardio-metabolic disease.
Resources are focused on two lead compounds, naproxcinod in phase 3
development for the treatment of 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 & Co., Inc.
NicOx S.A. is headquartered in Sophia-Antipolis, France, and is a public
company listed on the Euronext Paris (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 SA 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.com
NicOx: Karl Hanks - Manager of Corporate Relations and Market Analysis -
Tel +33 (0)4 97 24 53 42 - [email protected]
Investors in the United States - Burns McClellan: Lisa Burns -
[email protected]
Juliane Snowden - [email protected]
Media in the United States - FD: Jonathan Birt - Tel +1 212 850 56 34 -
[email protected]
Media in Europe - Citigate Dewe Rogerson: David Dible - Tel +44 (0)207 282
2949 - [email protected]
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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