SOUTH SAN FRANCISCO, Calif., Nov. 12, 2012 (GLOBE NEWSWIRE) -- OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced the presentation today of data from a Phase 2 trial of ZYBRESTAT (fosbretabulin) in patients with polypoidal choroidal vasculopathy (PCV), which has features similar to age-related macular degeneration (AMD), a degenerative eye disease.
PCV found more often in individuals of African-American and Asian descent is a disease involving abnormal blood vessels of the macula characterized by recurrent serosanguinous detachment of the retinal pigment epithelium (RPE), submacular hemorrhage and development of subretinal polyps with resulting vision loss. The FAVOR study (Fosbretabulin Against Vasculopathy of the Retina/Choroid) was a randomized, double-masked Phase 2 study conducted in 20 Asian patients at seven clinical trial sites, which compared the outcome of a single intravenous dose of ZYBRESTAT (15, 25, 35 or 45 mg/kg) with placebo. The data showed that there was a transient reduction in polyp activity seen with indocyanine green angiography (ICGA) in a patient treated with 15 mg fosbretabulin and a transient reduction in subretinal fluid seen on optical coherence tomography, or OCT, in a patient treated with 45 mg fosbretabulin. The proportion of eyes with worsened findings on OCT/ICGA was significantly higher in the placebo group (p=0.032). These data suggest that ZYBRESTAT even if administered only as a single dose intravenously may produce a transient reduction in both polyp activity and amount of subretinal fluid in patients with PCV, and that further clinical testing with a more practical topical formulation potentially in combination with photodynamic therapy (PDT), may be warranted. No drug-related serious adverse event was observed in the study.
The data were presented at the 2012 annual meeting of the American Academy of Ophthalmology, being held in Chicago, in a poster titled, "Phase 2 Clinical Trial of Intravenous Fosbretabulin in the Treatment of Polypoidal Choroidal Vasculopathy (Fosbretabulin Against Vasculopathy of the Retina/Choroid: FAVOR Study)" by Timothy Y. Y. Lai, MD, FRCS, FRCOphth , Chinese University Hong Kong, et al.
"We believe that ZYBRESTAT has potential as a treatment for PCV and other ocular diseases involving abnormal blood vessel formation, such as age-related macular degeneration, and could potentially improve upon injectable anti-angiogenic agents which are used to treat these diseases, but which may have limited efficacy," said Jai Balkissoon, MD, FACS, Vice President Clinical Development, OXiGENE.
OXiGENE has previously reported positive results from proof-of-concept Phase 2 studies using an intravenous formulation showing that ZYBRESTAT achieved the primary endpoint of stable disease in patients with myopic macular degeneration (MMD). OXiGENE has conducted preclinical studies with topical formulations of ZYBRESTAT which demonstrated attractive pharmacokinetic and safety properties and efficacy in destroying abnormal vasculature in a rat choroidal melanoma model. Data from the FAVOR study could be used to facilitate dose selection decisions for future clinical trials. OXiGENE is seeking collaborators for its ZYBRESTAT ophthalmology program, which could include future development of a topical-route ZYBRESTAT.
OXiGENE is a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer. The Company's major focus is developing vascular disrupting agents (VDAs) that selectively disrupt abnormal blood vessels associated with solid tumor progression. OXiGENE is dedicated to leveraging its intellectual property and therapeutic development expertise to bring life-extending and life-enhancing medicines to patients.
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