Approximately 32 patients are expected to be enrolled in the study, which will be conducted at the Ireland Cancer Center at University Hospitals of Cleveland. The trial was cleared by the U.S. Food and Drug Administration and the hospital's Investigational Review Board.
Researchers will evaluate CA4P's effectiveness in extending the survival of patients with advanced anaplastic carcinoma of the thyroid (ATC). A key objective will be to determine whether CA4P can double to 12 months the median survival of patients with advanced stages of the disease. ATC is an extremely aggressive disease with a poor prognosis and no established standard treatment therapy.
OXiGENE completed Phase I safety trials of CA4P in 2001. During those trials, one patient with ATC, who had exhausted all known treatment regimens used for this disease, responded completely to CA4P as a single-agent treatment. The patient has now been disease free for more than 36 months. Four other Phase I patients with other forms of thyroid cancer experienced various lengths of disease stabilization following CA4P treatments.
"In both animal models and Phase I human clinical studies, CA4P has demonstrated the ability to selectively target existing tumor vasculature, in essence starving the tumor by blocking the flow of blood that supplies it with oxygen and nutrients," said OXiGENE President and CEO Fred Driscoll. "Shepherding the compound into a Phase II trial is the most significant milestone for our company to date, and reinforces our position as the leader in this emerging area of cancer therapy."
"The pre-clinical and early clinical experience of CA4P makes the compound extremely well-suited for study in Phase II," said the trial's lead investigator, Scot C. Remick, M.D., Associate Professor of Medicine and International Health at University Hospitals of Cleveland and Case Western Reserve University School of Medicine. "Based on our Phase I experience, we are very pleased to continue development of this compound for the treatment of ATC. This clinical trial offers a unique opportunity to investigate a novel anti-tumor treatment, and to potentially establish CA4P as a new therapy."
In addition to the trial announced today, a Phase Ib trial of CA4P is underway at the University of Pennsylvania's Presbyterian Medical Center, where researchers are studying the VTA in combination with a chemotherapy drug called Carboplatin.
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 endothelial cells lining a tumor's blood vessels. This in turn blocks the flow of blood to the tumor, depriving it of oxygen and nutrients. The compound is a synthetic form of CA4, a natural substance found in the bark of the South African willow tree known as combretum caffrum. CA4 was identified and isolated in 1987 by Professor G. Robert Pettit, director of the Cancer Research Institute at Arizona State University.
"Our Phase II study represents an opportunity to assess the preliminary efficacy of CA4P in a specific indication," said Dai Chaplin, Ph.D., OXiGENE's chief scientific officer. "This is particularly exciting because our Phase I study resulted in a complete pathological response in a patient with the identical disease."
About OXiGENE
OXiGENE is the world leader in the development of vascular targeting agents that attack existing blood vessels associated with cancerous tumors and may have applications in certain forms of ocular disease and other conditions. OXiGENE is using its proprietary vascular targeting technology to develop new drugs designed to 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 about OXiGENE's Phase II trial of CA4P contains "forward-looking" statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: the number of patients to be enrolled in the trial; the objectives of the trial; the suitability of the compound for advanced study; the potential to define a new standard of care for the treatment of ATC; the potential efficacy of CA4P; 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; OXiGENE's ability to develop new drugs that will enhance the effectiveness of traditional cancer treatments; and OXiGENE'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: the ability to successfully enroll patients in the 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 is contained in OXiGENE's reports to the Securities and Exchange Commission, including OXiGENE's 10-Q, 8-K and 10-K reports. However, OXiGENE undertakes no obligation to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.
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