July 2, 2003.
Contact: Scott Solomon. email@example.com
Sharon Merrill Associates, Inc.
OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN) today announced that The Johns Hopkins University School of Medicine will begin a Phase I/II clinical trial of the Company's lead vascular targeting agent, Combretastatin A4 Prodrug (CA4P). The study will be conducted in patients with a retinal degenerative disease known as wet age-related macular degeneration (AMD). Between 2 million and 3 million people in the United States have significant vision loss caused by wet AMD. "From a scientific perspective, this trial is significant because it marks the first study of a vascular targeting agent, initially developed to treat cancer, in patients with wet AMD," said Fred Driscoll, OXiGENE's president and chief executive officer. "From a corporate perspective, this trial strategically broadens our clinical development program into a second major area. Both oncology and ophthalmology offer significant market opportunities with unmet therapeutic needs."
Under the trial protocol, which was reviewed by the U.S. Food and Drug Administration, approximately 20 patients are scheduled to participate in the study. The study is now open for enrollment at Johns Hopkins' Wilmer Eye Institute in Baltimore, Maryland. The trial will be led by Quan Dong Nguyen, M.D., assistant professor of ophthalmology, and Peter Campochiaro, M.D., professor of ophthalmology, at Wilmer. As OXiGENE announced in October 2002, the trial is being funded by The Foundation Fighting Blindness, Inc. (FFB), the nation's premier non-profit eye research organization, whose mission is to discover the causes, treatments and cures for degenerative retinal eye diseases.
"CA4P has exhibited very promising pre-clinical results in preventing and causing regression of choroidal neovascularization, the major cause of severe vision loss in patients with age-related macular degeneration," said Dr. Jerry Chader, the FFB's chief scientific officer and a former scientific director of the National Eye Institute. "AMD is a disease for which current treatments are inadequate, so we are eager to begin studying the potential of this compound in humans."
Robert Gray, chief executive officer of The Foundation Fighting Blindness, commented that the Combretastatin trial marks the first time that FFB has provided financial support of an FDA-approved clinical trial for neovascular age-related macular degeneration. "We are extremely pleased that CA4P has met all regulatory and institutional board requirements to allow this initial study of Combretastatin in patients with the wet form of AMD," he said. "Through innovative collaborations with industry leaders like OXiGENE, The Foundation Fighting Blindness is working to rapidly advance promising new therapies to clinical trials. We hope to soon see a host of new clinical trials for macular degeneration, retinitis pigmentosa and other retinal degenerative diseases."
Each year more than 500,000 new cases of wet AMD are diagnosed worldwide. In the U.S., macular degeneration is the leading cause of severe and irreversible vision loss in people over age 60. While wet AMD represents just 10 percent of all AMD cases, it is responsible for 90 percent of AMD-related blindness, according to Johns Hopkins. Neovascular AMD is marked by the formation of aberrant blood vessels beneath the retina that leak blood and fluid into the retina and can trigger a sudden and severe loss of vision. An article in the June 2003 issue of Nature Reviews – Drug Discovery estimates that, as the population ages, the number of wet AMD cases will grow fivefold.
CA4P, which is derived from the bark of the South African willow tree, is believed to work by damaging and destroying these new blood vessels. While the initial clinical focus of the compound has been solid tumor cancers, CA4P also has been evaluated in mouse and rabbit models as a treatment for ocular disease. The results of these studies suggest that CA4P may block the development and, most importantly, promote regression of choroidal neovascularization.
In addition to the wet AMD trial announced today, CA4P is being studied in four clinical trials in cancer patients.
Phase II single agent Anaplastic thyroid cancer
Phase I/II radiotherapy Lung, head & neck, prostate cancer
Phase I/II carboplatin and paclitaxel Ovarian cancer
Phase Ib2 carboplatin Various solid tumors
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