OXiGENE, Inc. (Nasdaq:OXGN), a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced today that the company presented an update on its ZYBRESTAT ophthalmology program, including encouraging preclinical data showing that the company’s topical formulation achieved target retina/choroid concentrations with minimal systemic exposure. OXiGENE has two topical formulations of ZYBRESTAT in development – an eye drop and a minitab – both of which have demonstrated attractive pharmacokinetic and safety properties and efficacy in destroying abnormal vasculature in a rat choroidal melanoma model. The company believes that a topical formulation could be ready for clinical development in early 2011.
The data were presented at Glaucoma and Retinopathies 2010 conference by Dai Chaplin, Ph.D., head of research and development and chief scientific officer at OXiGENE.
“We are pleased with the outcome of preclinical studies with our topical formulations and believe that ZYBRESTAT has significant potential as a safe, effective, potent topical product that can improve upon injectable anti-angiogenic agents which are the mainstay of treatment for conditions such as age-related macular degeneration, but which may have limited efficacy and inconvenient means of delivery,” said Dr. Chaplin. “We believe that our ZYBRESTAT ophthalmology program is achieving critical mass in demonstrating significant therapeutic and commercial potential. We look forward to presenting our data package to companies with strong ophthalmology franchises with the goal of partnering this promising program.”
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). The ongoing FAVOR (fosbretabulin against vasculopathy of the retina/choroid) is a 20-patient, randomized, controlled, double-masked single-dose study of intravenous-route ZYBRESTAT in patients with polypoidal choroidal vasculopathy or PCV, a form of choroidal neovascularization that can serve as a model disease for macular degeneration. Data from the FAVOR study is intended to facilitate dose selection decisions in subsequent studies with topical-route ZYBRESTAT.
Dr. Chaplin added: “We believe PCV represents an attractive development pathway, as anti-angiogenic drugs are not approved for this indication and have not been reported to have strong activity. Because the phenotype of pathological vasculature in patients with PCV is similar to that of tumor vasculature, PCV is likely to be particularly susceptible to treatment with a vascular disrupting agent, such as ZYBRESTAT. We expect to report data from the FAVOR study later in 2010.”