OXiGENE Inc announced that the European Agency for the Evaluation of Medicinal Products (EMEA) has awarded OXiGENE the Orphan Medicinal Product Designation for Combretastatin A4 Prodrug (CA4P) as a treatment for anaplastic thyroid cancer (ATC), the rarest and deadliest form of the disease. The Orphan Medicinal Product Designation provides OXiGENE with market exclusivity in the European Union for 10 years following CA4P's market authorization.
"The European Orphan Medicinal Product Designation represents another important regulatory achievement in our strategy to market our lead vascular targeting agent globally as a treatment for anaplastic thyroid cancer," said Fred Driscoll, OXiGENE's president and chief executive officer. "CA4P is being evaluated in anaplastic thyroid cancer patients at multiple centers in the U.S., and our plan is to continue to rapidly advance the compound toward registration."
The EMEA grants the Orphan Medicinal Product Designation for products that diagnose, prevent or treat life-threatening or very serious conditions affecting no more than five out of every 10,000 people in the European Union. Thyroid cancer, in all of its forms, is expected to account for nearly 15,000 new cases in the European Union in 2005, according to the World Health Organization.
In addition to the 10-year market exclusivity, incentives relating to the designation include assistance from the EMEA in developing protocol to maximize the chance of success in achieving market authorization, direct access to the centralized procedure for the marketing authorization application process, potential fee reductions relating to the application for marketing authorization, and eligibility for grants from the European Union and member states supporting research and development.
"Anaplastic thyroid cancer is one of the most aggressive forms of cancer," said Dai Chaplin, OXiGENE's chief scientific officer and head of research and development. "However, because anaplastic thyroid tumors are highly vascular structures, we believe they are especially susceptible to the blood-flow blocking mechanism of CA4P. In fact, in Phase I trials we saw a complete pathological response in one patient with ATC and prolonged periods of stable disease in four patients with medullary thyroid carcinoma."
In 2003, CA4P received the U.S. Food and Drug Administration's (FDA) orphan drug and fast track designations for the treatment of anaplastic thyroid cancer. CA4P currently is being evaluated in a Phase II trial of patients with advanced ATC and a Phase Ib/II trial in combination with chemotherapy and radiation in patients with newly diagnosed ATC.
Four other human studies of the investigational drug are being conducted. Three of these involve patients with various other forms of cancer and one is being conducted in patients with a non-life-threatening retinal disease known as wet age-related macular degeneration. More than 200 patients are expected to receive treatment in the six current clinical studies of CA4P.
OXiGENE is the world leader in the development of vascular targeting agents (VTAs), novel biopharmaceutical compounds designed to selectively target and destroy new blood vessels. The Company's lead compound, Combretastatin A4 Prodrug (CA4P), is in clinical development in patients with solid tumor cancers and wet age-related macular degeneration. Three other OXiGENE VTAs, OXi4503, OXi6197 and OXi8007, are in pre-clinical development.