NicOx S.A. has announced the results of a dose-ranging phase 2 study conducted with PF‑03187207 in Japanese patients with glaucoma by its partner Pfizer Inc. PF-03187207 is a nitric oxide-donating prostaglandin analog. The study was designed to compare the safety and efficacy of several doses of PF-03187207 to Xalatan (latanoprost) and enrolled 112 Japanese patients with primary open-angle glaucoma or ocular hypertension.
In terms of the reduction in diurnal intraocular pressure (IOP), compared to baseline, the two highest doses of PF‑03187207 showed an improvement over Xalatan 0.005% of up to 11%, although the study did not meet its primary endpoint at day 28. PF-03187207 appeared to be safe and well tolerated, with adverse events being mild.
In May 2008, NicOx announced the results of a 215 patient U.S. dose-ranging phase 2 study, in which the highest dose of PF-03187207 showed a 12% improvement over Xalatan 0.005% at day 28, but did not reach statistical significance. In both the Japanese and U.S. studies, PF-03187207 showed a 20% greater reduction in IOP at 20 hours post-dose compared to Xalatan 0.005%, which reached statistical significance in the U.S. study, suggesting a more sustained IOP lowering effect.
Following the results of the U.S. study, Pfizer decided not to launch a phase 3 program for PF-03187207 outside of Asia. After reviewing the results of this Japanese study, Pfizer has decided not to launch an Asian phase 3 program for PF-03187207. NicOx and Pfizer are currently in discussions regarding the rights to PF-03187207, to allow its potential continued development and commercialization. PF-03187207 is covered by the companies' August 2004 agreement.
Michele Garufi, Chairman and CEO of NicOx, commented: "We are encouraged that the results of the Japanese and U.S. studies are consistent and both suggest that nitric oxide donation may allow a more sustained intraocular pressure lowering effect. NicOx and Pfizer are in active discussions regarding the worldwide rights to PF-03187207, which we believe has a certain commercial potential which should be realized. We are also pleased by the progress that has been made in the research program focused on diabetic retinopathy, where we hope a lead compound will be selected in the first half of next year."
In January 2008, NicOx announced it had signed a one year extension of its March 2006 collaboration agreement, which grants Pfizer Inc the exclusive right to apply NicOx' proprietary nitric oxide-donating technology to drug discovery research across the entire field of ophthalmology.
Under this agreement, the joint NicOx-Pfizer research team will concentrate its efforts on an ongoing program to identify nitric oxide-donating compounds for diabetic retinopathy (see NOTE), with the aim of selecting a lead compound for development during the first half of 2009. Active research on these compounds was initiated following the signature of the March 2006 agreement and continues to make good progress. This agreement provides for total potential milestone payments of EUR 102 million for the successful full development and launch of the first program compound.
Pfizer has decided to no longer pursue the research on nitric oxide-donating prostaglandin analogs covered by this agreement.
NOTE: Diabetic retinopathy is retina damage due to diabetes, which can result in blindness. High blood sugar can damage ocular blood vessels, causing them to become blocked or leak fluid. Frequently a swelling of the retina or a build-up of protein deposits on the retina can be involved in the disease. In some cases there is a development of new, abnormal vessels, which can break and bleed into the center of the eye, inducing blindness.
Diabetic retinopathy causes 12,000 to 24,000 new cases of blindness each year in the United States and represents the leading cause of blindness among adults aged 20 to 74 years. In the US, 40-45% of adults diagnosed with diabetes have some degree of diabetic retinopathy. This corresponds to 3.4% of the population, that is to say 4.1 million US adults 40 years and older (2004). In addition to prevention through the management of blood sugar levels, the most established treatment for diabetic retinopathy is laser surgery.
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-Donator (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, widespread eye diseases 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).