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
Contact: Scott Solomon
Sharon Merrill Associates, Inc.