OXiGENE Announces Phase 2 Data on ZYBRESTAT to Treat the Eye Disease,
Polypoidal Choroidal Vasculopathy (PCV), Presented at the American Academy of
Ophthalmology 2012 Annual Meeting
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
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.
The OXiGENE, Inc. logo is available at
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