SOPHIA ANTIPOLIS, France, Jan. 3 /PRNewswire/ -- NicOx S.A. (Euronext Paris: COX) today announced that Pfizer Inc (NYSE: PFE) 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(R) (latanoprost) in Japanese patients with these conditions. Xalatan(R) 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(R) 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(R). 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 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).
SOURCE NicOx S.A.