OXiGENE Initiates Phase-II Trial Of Zybrestat

OXiGENE has initiated the phase-II study of vascular disrupting agent drug candidate, Zybrestat for ophthalmology in patients with polypoidal choroidal vasculopathy (PCV).

The phase-II favor study is a single-dose, randomized, double-masked, placebo-controlled trial, will be conducted at up to 10 sites in multiple countries in Asia.

The study will examine effects of Zybrestat on PCV assessed as a change from baseline in the number of polypoid lesions, as measured by imaging with indocyanine green angiography. It will also examine changes to the vascular network, edema and retinal thickness.

John Kollins, CEO of OXiGENE, said: The initiation of the Favor study is an important milestone in our ophthalmology program and lays the groundwork for conducting a clinical program with a topical formulation of Zybrestat, which we believe may represent a significant opportunity for treating this debilitating eye disease.

Our primary goals for the Favor study are to establish the concentrations of Zybrestat in the retina and choroid that are required for activity, enable determination of an appropriate topical-route dose, and provide proof-of-concept for this therapeutic approach. Assuming data from the Favor study and preclinical studies are supportive, we anticipate being in a position to initiate a Phase 1 trial with topical-route Zybrestat with a rationally-determined dose and schedule in 2010, he added.