OXiGENE, Inc, a clinical-stage, biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, said its anti-tumour drug candidate Zybrestat met initial goals in a phase II clinical trial.

The trial with topical formulations of Zybrestat for ophthalmologic indications, were performed in industry-standard rabbit models. The mid-stage trial indicated that two formulations of Zybrestat, when applied topically to the surface of the eye, are absorbed and result in concentrations of drug in target tissues in the back of the eye (i.e., the retina and choroid). OXiGENE believes that it would be sufficient for therapeutic activity in age-related macular degeneration (ARMD) and potentially other eye diseases in which abnormal neovascularization plays a role. These results confirm preliminary results seen in earlier preclinical studies, said a company press release.

"Achieving therapeutic concentrations of Zybrestat with topical delivery in relevant ocular tissues, such as the retina, in preclinical models represents a key milestone in OXiGENE's ophthalmology programme," said Richard Chin, M.D, president and chief executive officer, OXiGENE. "Having previously observed in clinical trials that intravenously-administered Zybrestat has clinical activity in patients suffering from a form of macular degeneration, we believe a topical formulation of Zybrestat that delivers sufficient quantities of drug to target tissues in the eye has a high likelihood of demonstrating activity in the clinic. We now have results from multiple preclinical studies suggesting that development of such a formulation is feasible, and we believe that a topical formulation of Zybrestat could potentially be a major advance for patients with a variety of ophthalmic diseases and conditions."

Tolerability of the formulations was favourable in the rabbit studies, confirming data from earlier rodent studies. Based on these results, OXiGENE is proceeding with further preclinical studies in non-rodent models, which, if consistent with results from rabbit and rodent studies, are expected to provide support for an IND submission, currently planned for the first half of 2008.

In February 2007, OXiGENE announced positive results from a Phase II clinical trial of intravenous Zybrestat in 23 patients with myopic macular degeneration. All patients achieved the primary endpoint of the trial, stabilization of vision.

Zybrestat is currently being evaluated in a pivotal registration study in anaplastic thyroid cancer (ATC) under a Special Protocol Assessment agreement with the US Food and Drug Administration (FDA). OXiGENE believes that Zybrestat is poised to become the first therapeutic product in a novel class of small-molecule drug candidates called vascular disrupting agents (VDAs). Through interaction with vascular endothelial cell cytoskeletal proteins, Zybrestat selectively targets and collapses tumour vasculature, thereby depriving the tumour of oxygen and causing death of tumour cells. In clinical studies in solid tumours, Zybrestat has demonstrated potent and selective activity against tumour vasculature, as well as clinical activity against ATC, ovarian cancer, and various other solid tumours. In clinical studies in patients with forms of macular degeneration, intravenously-administered Zybrestat has demonstrated clinical activity, and the Company is working to develop a convenient and patient-friendly topical formulation of Zybrestat for ophthalmological indications.

OXiGENE is a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases. The company's major focus is developing VDAs that selectively disrupt abnormal blood vessels associated with solid tumour progression and visual impairment.