OXiGENE's Lead Cancer-Fighting Agent Receives Fast Track Designation from U.S. FDA.Business Editors/Health/Medical Writers BIOWIRE2K WATERTOWN, Mass.--(BUSINESS WIRE)--June 4, 2003 Tumor-starving Compound CA4P Eligible for Expedited Review for Rarest and Deadliest Form of 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. 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 U.S. Food and Drug Administration (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. ) has granted "fast track" designation to the Company's lead tumor-starving compound, Combretastatin A4 Prodrug prodrug /pro·drug/ (-drug) a compound that, on administration, must undergo chemical conversion by metabolic processes before becoming an active pharmacological agent; a precursor of a drug. (CA4P), for the treatment of advanced 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 (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 ). CA4P currently is being evaluated in a Phase II study of patients with this disease. "The fast track designation represents a major regulatory accomplishment in our strategy to advance CA4P through the clinical trial process as rapidly as possible in anaplastic thyroid cancer," said OXiGENE President and Chief Executive Officer Fred Driscoll. "The FDA's decision reflects the urgent and unmet need for therapies to treat ATC, and validates the potential of our development plan to address the disease. This designation creates opportunities to meet with the FDA on an expedited basis to review our plan and receive ongoing input from the Agency into the design of clinical efficacy studies needed to support market approval." The FDA's fast track program is intended to facilitate the development and expedite the review of new drugs intended to treat life-threatening conditions for which there is no approved therapy. The fast track designation applies to the combination of the drug candidate and a specific disease indication. OXiGENE chose to pursue advanced-stage clinical development of CA4P for ATC after evaluating the results of Phase I safety studies of the compound. In one trial, an ATC patient was deemed a complete responder to treatment with CA4P. This patient completed treatment in October 1999 and has been cancer free since. Four additional Phase I patients with other forms of thyroid cancer experienced periods of prolonged disease stabilization following CA4P treatments. An estimated 22,000 new cases of thyroid cancer are expected to be diagnosed in the U.S. in 2003. ATC is the rarest and deadliest of the four main forms of the disease. Clinicians at the Ireland Cancer Center at University Hospitals of Cleveland University Hospitals is a major not-for-profit medical center in Cleveland, Ohio, United States. With 150 locations throughout northeast Ohio, it encompasses a network of hospitals, outpatient centers and primary care physicians. (Case Western Reserve University) are studying the effects of CA4P in patients with ATC. A key objective of this Phase II trial is to determine whether CA4P can extend to 12 months the median survival of patients with regionally advanced or metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. ATC. The current life expectancy Life Expectancy 1. The age until which a person is expected to live. 2. The remaining number of years an individual is expected to live, based on IRS issued life expectancy tables. of those patients is four to six months. In addition to requesting the fast track designation, OXiGENE has asked the FDA to award CA4P 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 Status for the treatment of ATC. The first sponsor to obtain market approval for an orphan drug-designated product is guaranteed seven years of market exclusivity, tax credits and other benefits. CA4P, the water-soluble prodrug of Combretastatin A4, a compound isolated from the African bush willow Combretum Caffrum, is designed to damage and destroy solid tumors by choking off the flow of blood that enables them to grow and thrive. Research in animal models has shown that CA4P works by rapidly and selectively disrupting the function of the immature endothelial cells Endothelial cells The cells lining the inner walls of the blood vessels. Mentioned in: Von Willebrand Disease that line the vascular network of tumors. About OXiGENE OXiGENE is the world leader in the development of novel biopharmaceutical compounds called vascular targeting agents (VTAs), which are designed to block the flow of blood that supplies solid cancer tumors and other abnormal vasculature vasculature /vas·cu·la·ture/ (vas´ku-lah-chur) 1. circulatory system. 2. any part of the circulatory system. vas·cu·la·ture n. while leaving healthy cells intact. The Company's VTAs may have application in the treatment of certain forms of ocular disease and other conditions. OXiGENE's lead compound, Combretastatin A4 Prodrug, has advanced into Phase II and combination clinical trials in cancer patients in the United States and Europe. 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 This news release about the FDA's granting of the fast track designation to Combretastatin A4 Prodrug for the treatment of advanced ATC contains "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 strategy to advance CA4P through the clinical trial process as rapidly as possible in the treatment of anaplastic thyroid cancer; the potential of the development plan submitted by OXiGENE to address ATC; the Company's ability to obtain Orphan Drug Status for CA4P; and the applicability of CA4P to certain forms of ocular disease and other conditions. 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 inability 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. |
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