SOUTH SAN FRANCISCO, Calif., June 25, 2009 (GLOBE NEWSWIRE) -- OXiGENE, Inc., a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases, announced that the Company has initiated a Phase 2 study of its vascular disrupting agent (VDA) drug candidate ZYBRESTAT for ophthalmology in patients with polypoidal choroidal vasculopathy (PCV). PCV is a form of choroidal neovascularization characterized by the growth of abnormal blood vessels in the back of the eye and is similar to wet age-related macular degeneration (AMD). Current therapies active against wet AMD appear to have limited benefits in patients with PCV, and OXiGENE believes the abnormal vasculature in the retina and choroid that contributes to PCV patients' loss of vision may be susceptible to treatment with ZYBRESTAT.
The Phase 2 FAVOR (Fosbretabulin Against Vasculopathy of the Retina/choroid) study is a single-dose, randomized, double-masked, placebo-controlled trial being conducted at up to 10 sites in multiple countries in Asia and is expected to enroll approximately 40 patients. Patients will receive one of four dose levels of intravenous ZYBRESTAT (fosbretabulin) or a placebo on Day 1, and will return for ophthalmologic assessments on Days 2, 8, 15, and 29. 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 (ICGA) as well as changes to the vascular network, edema and retinal thickness. The Company expects to announce top-line data from the Phase 2 trial in the first half of 2010.
A key objective of the FAVOR study is estimation of retina/choroid drug concentrations required for activity. Depending upon the results of the FAVOR study and ongoing preclinical studies, the Company plans to advance clinical development of a topically administered formulation of ZYBRESTAT for PCV and/or other ophthalmological indications.
"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," said John Kollins, Chief Executive Officer for OXiGENE, Inc. "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."
Clinicians and other medical professionals who would like more information about this study may contact OXiGENE at 650-635-7000.
About PCV
The choroid is the vascular layer at the back of the eye that lies between the retina and the sclera. In patients with PCV, dense clusters of polyp-like vascular structures, or polypoids, can be observed on the choroid with ICG angiography. Studies suggest that these polypoids may exist in up to one-third of wet AMD patients. The vascular phenotype of these polypoids is similar to the immature or abnormal tumor vasculature that is particularly responsive to VDA therapy. To date, there are no approved therapies for PCV, and anti-VEGF and photodynamic therapies have shown limited utility. OXiGENE is targeting this indication because it represents a significant unmet medical need that is not being addressed with current therapeutic products, including approved VEGF inhibitors. The Company believes that because ZYBRESTAT is a vascular disrupting agent, it has a mechanism of action that could target these polypoids more effectively than agents currently being used, and may have meaningful therapeutic advantages.
About ZYBRESTAT
ZYBRESTAT is currently being evaluated in a pivotal registration study in anaplastic thyroid cancer (ATC) under a Special Protocol Assessment agreement with the U.S. 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 tumor vasculature, thereby depriving the tumor of oxygen and causing death of tumor cells. In clinical studies in solid tumors, ZYBRESTAT has demonstrated potent and selective activity against tumor vasculature, as well as clinical activity against ATC, ovarian cancer and various other solid tumors. In clinical studies in patients with forms of macular degeneration, intravenously-administered ZYBRESTAT has demonstrated activity, and the Company's objective is to develop a topical formulation of ZYBRESTAT for ophthalmological indications. OXiGENE is developing ZYBRESTAT for ophthalmology under the strategic drug development partnership it established with Symphony Capital in October 2008.
About OXiGENE
OXiGENE is a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer and eye diseases. The Company's major focus is developing vascular disrupting agents (VDAs) that selectively disrupt abnormal blood vessels associated with solid tumor progression and visual impairment. OXiGENE is dedicated to leveraging its intellectual property and therapeutic development expertise to bring life-extending and life-enhancing medicines to patients.
The OXiGENE, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=4969
Safe Harbor Statement
This news release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Any or all of the forward-looking statements in this press release may turn out to be wrong. Forward-looking statements can be affected by inaccurate assumptions OXiGENE might make or by known or unknown risks and uncertainties, including, but not limited to, those relating to the timing and results of the FAVOR study. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in OXiGENE's reports to the Securities and Exchange Commission, including OXiGENE's reports on Form 10-K, 10-Q and 8-K. However, OXiGENE undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise. Please refer to our Annual Report on Form 10-K for the fiscal year ended December 31, 2008.