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Phase 2 Clinical Trial Initiated for CA4P in Myopic Macular Degeneration
"The initiation of this Phase II trial in such a debilitating disease as MMD represents a significant advancement in the development of our ophthalmology program and is testimony to the positive results seen so far in our CA4P trials," said Fred Driscoll, President and Chief Executive Officer of OXiGENE. "This trial brings OXiGENE closer to realizing its primary corporate goal of moving CA4P rapidly into the marketplace. The encouraging results seen to date in our ongoing Phase I/II wet age-related macular degeneration trial in conjunction with numerous positive pre-clinical studies have caused us to aggressively move forward into this additional indication. At this time we are unaware of any other investigational compounds being studied in MMD."
This Phase II clinical trial is an open label, dose ranging, international multi-centered study that will assess the safety and efficacy of CA4P in the treatment of MMD. The Company expects to enroll patients with active choroidal neovascularization associated with MMD in the trial. Patient progress will be monitored by visual acuity and state of the art techniques such as fluorescein angiography and optical coherence tomography (OCT), which the Company anticipates will lead to a greater understanding of the biological activity of CA4P in this setting.
"This disease can be devastating for patients who are often afflicted with severe visual impairment at a relatively young age. Unfortunately, there are currently few treatment options for this disease." Said Dr. Dai Chaplin, Chief Scientific Officer at OXiGENE. "We are pleased that the safety profile of CA4P has allowed us to progress into a Phase II clinical trial in a non-life-threatening disease such as MMD. We believe the ability of CA4P to disrupt the function of newly formed blood vessels provides the potential for its use in MMD and a number of other diseases where abnormal neovascularization underlies the disease pathology."
MMD is a progressive eye disease characterized by blurring of the central vision and distortion of certain shapes and images, which cannot be corrected by prescription or contact lenses. The disease initially begins with the progressive elongation of the eye; it is not known whether the degenerative changes are the result of this elongation or other hereditary factors. Visual loss may be severe, and may occur due to atrophic changes or the occurrence of abnormal new vessels growing up through defects in the abnormal retina. The abnormal blood vessels grow from the choroid behind the eye and infiltrate the retina, causing hemorrhaging and scarring, often resulting in central visual loss. Once this process, known as choroidal neovascularization, occurs and active blood vessel leakage in the eye is present, the disease is then considered myopic macular degeneration.
About Combretastatin A4P (CA4P)
CA4P leads a novel class of drug candidates called vascular targeting agents (VTAs). CA4P attacks the vascular structure of solid tumors and other diseases characterized by the formation of aberrant blood vessels. The compound triggers a change in the shape of the endothelial cells lining these blood vessels, in turn, blocking the flow of blood to a tumor and depriving it of oxygen and nutrients essential to its survival. Similarly, in eye diseases that are characterized by abnormal blood vessel growth, CA4P has been pre-clinically shown to suppress development and induce regression of these unnecessary blood vessels.
CA4P is currently being studied in six clinical trials in oncology, including anaplastic thyroid, lung, head and neck, prostate, colorectal, ovarian and cervical cancers. These clinical trials involve the use of CA4P in both single agent and multiple treatment modalities. It is also currently being studied in a Phase I/II trial in wet age-related macular degeneration.
Source: Oxigene, Inc.