OXiGENE's Combretastatin A4 Prodrug Granted European Union Orphan Medicinal Product Designation for Anaplastic Thyroid Cancer.Business Editors/Health/Medical Writers WALTHAM, Mass.--(BUSINESS WIRE)--April 19, 2004 OXiGENE, Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : OXGN, XSSE: OXGN) announced today that the European Agency for the Evaluation of Medicinal Products (EMEA (Europe, Middle East, Africa) Refers to that region of the world. For example, one might see products packaged differently for the UK, EMEA and Asia Pacific markets. ) has awarded OXiGENE the Orphan Medicinal Product Designation for Combretastatin A4 Prodrug (CA4P) as a treatment for anaplastic an·a·plas·tic adj. 1. Relating to the surgical restoration of a lost or absent part. 2. Of, relating to, or characterized by cells that have become less differentiated. anaplastic 1. thyroid cancer Thyroid Cancer Definition Thyroid cancer is a disease in which the cells of the thyroid gland become abnormal, grow uncontrollably, and form a mass of cells called a tumor. (ATC ATC Air Traffic Control ATC Average Total Cost ATC Certified Athletic Trainer ATC At the Center (Hartford, Maine retreat center) ATC Applied Technology Council ATC All Things Considered ), the rarest and deadliest form of the disease. The Orphan Medicinal Product Designation provides OXiGENE with market exclusivity in the European Union European Union (EU), name given since the ratification (Nov., 1993) of the Treaty of European Union, or Maastricht Treaty, to the European Community 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, Ph.D., 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 medullary /med·ul·lary/ (med´ah-lar?e) 1. pertaining to a medulla. 2. pertaining to bone marrow. 3. pertaining to the spinal cord. thyroid carcinoma." In 2003, CA4P received the U.S. Food and Drug Administration's (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) orphan drug orphan drug, drug developed under the U.S. Orphan Drug Act (1983) to treat a disease that affects fewer than 200,000 people in the United States. The orphan drug law offers tax breaks and a seven-year monopoly on drug sales to induce companies to undertake the 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 Age-related macular degeneration (ARMD) Degeneration of the macula (the central part of the retina where the rods and cones are most dense) that leads to loss of central vision in people over 60. . More than 200 patients are expected to receive treatment in the six current clinical studies of CA4P. About OXiGENE 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 Blood vessels Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names. . 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. For more information about OXiGENE, visit www.oxigene.com. Safe Harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. Statement Statements in this news release concerning the issuance of the EMEA Orphan Medicinal Product Designation are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and of 1995. These statements include, but are not limited to OXiGENE's plan to market CA4P globally as a treatment for anaplastic thyroid cancer, the Company's ability to secure market registration and the number of patients expected to receive treatment in the current clinical studies of CA4P. 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 OXiGENE might make or by known or unknown risks and uncertainties, including, but not limited to: the early stage of product development; the ability to secure necessary patents; 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 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 because of new information, future events or otherwise. |
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion