FDA Grants Orphan Drug Status to OXiGENE's Combretastatin A4 Prodrug for Multiple Forms of Thyroid Cancer.Business Editors/Health/Medical Writers WATERTOWN, Mass.--(BUSINESS WIRE)--July 28, 2003 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, in response to the Company's application, the U.S. Food and Drug Administration has awarded 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 to OXiGENE's Combretastatin A4 Prodrug (CA4P) for the treatment of 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 ). In addition, the 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. granted the orphan drug designation to CA4P for the treatment of 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. , Stage IV papillary papillary /pap·il·lary/ (pap´i-lar?e) pertaining to or resembling a papilla, or nipple. papillary, adj similar to a small, nipple-shaped elevation or projection. and Stage IV follicular fol·lic·u·lar adj. 1. Relating to, having, or resembling a follicle or follicles. 2. Affecting or growing out of a follicle or follicles. thyroid cancers. OXiGENE estimates that approximately 58,000 people in the United States currently have one of these four cancer sub-types. CA4P is being tested in a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II in patients with advanced ATC, one of four concurrent human oncology studies of the investigational drug. "As we advance CA4P to market, the orphan drug designation - and the FDA fast track Fast Track is a designation of the Food and Drug Administration that accelerates the approval of experimental drugs, such as experimental cancer treatments, that treat a serious or life-threatening medical condition for which no other drug either exists or works as well. designation we announced last month - represent key building blocks in our clinical development and commercialization strategy," said Fred Driscoll, OXiGENE's president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "The FDA's decision recognizes the potential for CA4P to be a cornerstone treatment not only for ATC but for other sub-types and stages of thyroid cancer, which would fill a significant unmet medical need." In the course of OXiGENE's Phase I safety trials of CA4P, which were completed in 2001, 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 44 months. One Phase I patient with medullary thyroid cancer Medullary thyroid cancer (MTC) A slow-growing tumor associated with MEN. Mentioned in: Multiple Endocrine Neoplasia Syndromes experienced 17 months of disease stabilization, while a second medullary patient remained stable for one year. "Thyroid tumors are known to be highly vascularized, and thus we believe they may be particularly susceptible to the blood-flow blocking effects triggered by vascular targeting compounds such as CA4P," said Scott Young, OXiGENE's Vice President of Clinical and Regulatory Affairs. "The FDA's decision to broaden the orphan drug designation to include multiple forms of thyroid cancer provides OXiGENE with a strong incentive to evaluate the potential clinical development of CA4P in these other thyroid tumor types." Orphan drug designations are granted to provide economic incentives to stimulate the research, development and approval of promising products that treat rare diseases. The Orphan Drug Act guarantees seven years of market exclusivity to the first sponsor that obtains market approval for an orphan drug-designated product. It also provides tax credits to defray the cost of research conducted to generate the data required for marketing approval, funding to support clinical trials and assistance in designing research studies. In June, CA4P received the FDA's fast track designation for the treatment of anaplastic thyroid cancer. The fast track program is intended to facilitate the development and review of new drugs intended to treat life-threatening conditions for which there is no approved therapy. A summary of the current clinical trials involving CA4P:
Clinical Trial Combination Indications
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Phase II single agent Anaplastic thyroid
cancer
Phase I/II radiotherapy Lung, head & neck and
prostate cancer
Phase I/II carboplatin and paclitaxel Ovarian cancer
Phase Ib(1) carboplatin Various solid tumors
Phase I/II single agent Wet age-related macular
degeneration
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(1) Patient enrollment has concluded
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 VTA VTA Valley Transportation Authority (San Jose, California) VTA Ventral Tegmental Area VTA Vacuum Triode Amplifier VTA VFR Terminal Area VTA Martha's Vineyard Transit Authority (Massachusetts) , Combretastatin A4 Prodrug, has advanced into Phase II and combination clinical trials in cancer patients in the United States and Europe. Three other OXiGENE VTAs, OXi4503, OXi6197 and OXi8007, are in pre-clinical development. For more information about OXiGENE, visit www.oxigene.com. Safe Harbor Statement This news release 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 ability to advance CA4P to market; the susceptibility of thyroid tumors to damage by CA4P; the ability of CA4P to be a cornerstone treatment for various stages or sub-types of thyroid cancer including ATC; the possibility that OXiGENE will pursue the potential benefits of CA4P as a treatment for a broad range of thyroid cancers; and the applicability of CA4P to certain forms of ocular disease. 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. |
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