December 11, 2003.
Contact: Scott Solomon,
Sharon Merrill Associates, Inc.
– OXiGENE, Inc. today announced a significant expansion of its research and development program in ophthalmology, including plans to begin human studies in several retinal degenerative indications and to develop formulations of its lead vascular targeting agent, Combretastatin A4 Prodrug (CA4P), for local delivery to the eye.
OXiGENE determined to broaden its ophthalmic clinical program after a 35-year-old man suffering from myopic macular degeneration showed dramatic improvement following treatment with CA4P. The patient was treated this fall by clinical investigators at the Wilmer Eye Institute of the Johns Hopkins University School of Medicine. The Wilmer Eye Institute is conducting a human study of CA4P for the treatment of a related condition, wet age-related macular degeneration, or wet AMD. The trial is being led by Assistant Professor of Ophthalmology Quan Dong Nguyen, M.D., and Professor of Ophthalmology Peter Campochiaro, M.D. Although the specifics of the patient's condition excluded him from participating in the wet AMD trial, the patient was treated by these investigators under a special U.S. Food and Drug Administration (FDA) exemption.
Prior to beginning a regimen of CA4P treatments, the patient had visual acuity of 20/50 in the study eye with active leakage in both eyes that had persisted following other treatment approaches. After the patient was treated with the systemically administered CA4P, his vision has been restored to 20/20 with significantly reduced leakage in each eye.
"The clinical investigators have told us that the patient has clearly responded to CA4P and has had a significant improvement in vision," said OXiGENE President and Chief Executive Officer Fred Driscoll. "This significant improvement in visual acuity and underlying pathology seen in this first patient, together with our current understanding of the safety profile of CA4P gleaned from our numerous ongoing oncology and ophthalmology studies, has stimulated us to expand our development strategy. We now plan to broaden our research and development initiatives and expect to launch a clinical study in myopic degeneration and other diseases complicated by subfoveal choroidal neovascularization. In addition, we will actively pursue the introduction of local formulations of CA4P and other non-systemic methods of administering the compound for ophthalmic indications.
"The decision to broaden our focus in ophthalmology in no way affects the clinical progress CA4P has made in oncology," Driscoll said. "Today's announcement reflects the fact that, based on this encouraging clinical development in ophthalmology, OXiGENE intends to be fully engaged in the development of our vascular targeting agents on both major fronts, oncology and ophthalmology."
High myopia (extreme near sightedness) is a condition in which the feedback mechanisms that tell the eye when to stop growing are dysfunctional and so the eye gets larger than normal. But not all of the tissues continue to grow; rather, they stretch and thin out. The retina and Bruch's membrane (the tissue behind the retina that separates it from the blood vessels of the choroids) are two of the tissues that stretch and become thin. The thinning of the retina in the macula can result in gradual decrease in vision and is called myopic macular degeneration. The thinning of Bruch's membrane can result in cracks through which new blood vessels can grow from the choroid underneath the retina. When this occurs beneath the fovea, it is called subfoveal choroidal neovascularization and often causes sudden and severe loss of vision. There are several other conditions that occur in relatively young patients, such as Ocular Histoplasmosis and Angioid Streaks, in which breaks in Bruch's membrane occur and are complicated by subfoveal choroidal neovascularization.
CA4P is believed to work by damaging and destroying newly formed blood vessels. Pre-clinical studies involving mouse and rabbit models of ocular disease conducted at leading research institutions have reported that CA4P blocks the development and, most importantly, promotes regression of choroidal neovascularization.
"From a research perspective, what makes this so exciting is that this significant response in man replicates what independent researchers have seen with CA4P in their animal models of ocular neovascularization," said Dai Chaplin, Ph.D., OXiGENE's head of research and chief scientific officer. "The response to CA4P in this patient with subfoveal choroidal neovascularization due to myopic degeneration suggests that CA4P should be tested in all the conditions in which breaks in Bruch's membrane lead to subfoveal choroidal neovascularization. Also it gives us the impetus to accelerate our development of non-systemic delivery routes for CA4P. Early data in preclinical models has already established that when CA4P is delivered to the eye by means of drops it can be detected in relevant posterior compartments of the eye."
"The results achieved in this patient are especially significant and provide great hope for other patients with myopic macular degeneration. These patients have few treatment options and ultimately experience debilitating vision loss," said Gerald Chader, Ph.D., chief scientific officer of the Foundation Fighting Blindness, which is funding the wet AMD trial. Dr. Chader also is a former scientific director of the National Eye Institute. "We applaud OXiGENE for its initiatives in the area of retinal degenerative disease and its decision to significantly expand its research and development efforts."
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