Under the agreement, which is conditioned upon certain regulatory and institutional review board approvals, The Foundation has agreed to fund a physician-sponsored Phase I/II human clinical trial. The study will evaluate the safety and effectiveness of CA4P as a treatment for a retinal disease known as wet age-related macular degeneration (AMD). In the area of oncology, OXiGENE has already completed Phase I clinical trials of CA4P. A Phase Ib combination trial of CA4P and the chemotherapeutic agent Carboplatin is now being conducted and proceeding as planned at the University of Pennsylvania.
"We are honored that the nation's premier charitable eye research organization has chosen to support research of our lead vascular targeting compound," said Frederick Driscoll, OXiGENE's president and CEO. "The Foundation brings to this initiative not only funding but relationships with world-class researchers and clinicians. The Foundation's participation in this program and the pre-clinical work we have already completed in the area of retinal disease provide the groundwork to begin an early-stage clinical trial. We expect to announce the timing, location and protocol for this study in 2003, once all required approvals have been obtained."
"Our work with biotechnology companies like OXiGENE is to discover and test novel compounds that -- like Trojan Horses -- can deftly evade the retina's defenses and combat degenerative diseases," said Gerald J. Chader, Ph.D., M.D., hc, The Foundation's chief scientific officer. "The preliminary CA4P data presented at ARVO (Association for Research in Vision and Ophthalmology) suggests that the compound inhibits the growth of proliferating blood vessels linked to retinal conditions such as wet AMD. To give you a sense of how encouraged we are about the potential of CA4P, this marks the first time in the 31-year history of The Foundation that we have funded a compound for human clinical trials."
Wet AMD is the cause of significant vision loss in nearly two million Americans, and each year more than 500,000 people worldwide develop the disease. Wet AMD is a form of macular degeneration, the leading cause of blindness in the U.S. for people age 55 and older.
At the ARVO annual meeting in May 2002, researchers presented data from three pre-clinical studies indicating CA4P's potential therapeutic applicability as a treatment for diseases associated with ocular neovascularization. Wet AMD is characterized by the abnormal growth of blood vessels beneath the eye's retinal tissue. This growth triggers a leakage of fluid that injures the photoreceptor cells that discriminate color vision and fine visual detail.
Dai Chaplin, OXiGENE's chief scientific officer, said one of the most important findings to emerge from the vision-related research into CA4P is the drug's pinpoint targeting. "Researchers have noted in animal studies CA4P's uncommon ability to enable development of normal blood vessels in the retina while inhibiting the growth of aberrant vasculature," Chaplin said. "These findings are consistent with our completed Phase I clinical trials of CA4P in solid cancer tumors."
CA4P's potential role in the treatment of diabetes-related blindness was demonstrated in animal data published this year by researchers at the University of Cambridge in the United Kingdom. In an independent study published in the American Journal of Pathology, investigators concluded that, dependent on dosage, CA4P can inhibit growth of abnormal vasculature -- with no apparent side effects noted.
About The Foundation Fighting Blindness
The Foundation Fighting Blindness (www.blindness.org), recently designated by Worth Magazine as one of the 100 Best Charities in the country, is the largest non-governmental source of funding for retinal degenerative disease research in the world. Based on National Health Council findings, The Foundation is consistently rated # 1 among major charitable organizations for the percentage of revenue spent on research. The Foundation funds leading-edge research in promising areas such as genetics, gene therapy, retinal cell transplantation, retinal implants and pharmaceutical and nutritional therapies. Since its inception in 1971, The Foundation has raised $150 million for retinal degenerative disease research.
OXiGENE is the world leader in vascular targeting agents that attack existing blood vessels associated with cancerous tumors, and which may have an application in the treatment of restenosis, certain forms of ocular disease and other conditions. OXiGENE is using its proprietary vascular targeting technology to develop new drugs that will enhance the effectiveness of traditional cancer treatments and to introduce innovative therapies that attack cancer and other diseases. For more information about OXiGENE, visit www.oxigene.com.
Safe Harbor Statement
This news release contains forward-looking statements made under the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, the proposed funded research agreement between OXiGENE and The Foundation Fighting Blindness, Inc. proceeding as planned; the proposed Phase I/II clinical trial to evaluate the safety and effectiveness of CA4P as a treatment for retinal diseases including wet age-related macular degeneration proceeding as planned; the efficacy of CA4P as a treatment for ocular disease including wet AMD; CA4P's ability to enable development of normal blood vessels and/or inhibit the growth of aberrant vasculature; the efficacy of OXiGENE's vascular targeting agents in treating cancerous tumors; the Company's ability to develop new drugs that will enhance the effectiveness of traditional cancer treatments; and the Company's ability to introduce innovative therapies that attack cancer and other diseases. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions we might make or by known or unknown risks and uncertainties, including, but not limited to, in the case of the funded research agreement, the failure of the physician-investigator to file the required IND, the failure of the FDA to approve the required IND, the failure of the physician-investigator to enter into a satisfactory clinical trial agreement with the research institution, the ability to successfully enroll patients in the trial and the sufficiency of the amount of funds The Foundation has agreed to provide to cover the entire cost of the clinical trial, the early stage of product development; uncertainties as to the future success of ongoing and planned clinical trials and the unproven safety and efficacy of products under development. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements are contained in our reports to the Securities and Exchange Commission including our 10-Q, 8-K and 10-K reports. However, we undertake no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.
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