OXiGENE Expands Oncology Program by Introducing Lead Compound into Cervical Cancer Trials; CA4P Now Being Studied in Six Trials in Oncology.WALTHAM, Mass. -- 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 its lead 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), will enter into a Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I in combination with cisplatin cisplatin /cis·plat·in/ (sis´plat-in) DDP; a platinum coordination complex capable of producing inter- and intrastrand DNA crosslinks; used as an antineoplastic. cis·plat·in n. for cervical cancer Cervical Cancer Definition Cervical cancer is a disease in which the cells of the cervix become abnormal and start to grow uncontrollably, forming tumors. . With this study, CA4P, a vascular targeting agent (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) ) will be involved in six concurrent human oncology trials in seven tumor types in the United States and Europe. "This study is part of our continued efforts to accelerate CA4P toward approval and represents the achievement of one or our stated goals for 2004," said Fred Driscoll, President and Chief Executive Officer of OXiGENE. "Strong pre-clinical data showing that CA4P in combination with cisplatin enhances tumor cell death in mice by 10-500 fold was published in the International Journal of Cancer in 2002. Our portfolio of combination trials, such as this, aim to demonstrate the compound's potential to significantly improve the clinical benefits in multiple modalities and cancer indications." CA4P will be studied in combination with cisplatin, a primary chemotherapeutic treatment for cervical cancer, in a dose-escalating open label Phase I trial that is being launched by Dr. Jacob Lindegaard from the Aarhus University Hospital in Denmark. Approximately 18 patients with advanced or recurrent cervical cancers incurable by standard treatments are expected to be recruited beginning in the next several months. Dr. Lindegaard, a member of the Nordic Society of Gynecological gynecological /gy·ne·co·log·i·cal/ (-kah-loj´i-k'l) gynecologic. Oncology (NSGO NSGO National Sea Grant Office ), will head up three clinical sites to be opened in Denmark, Norway, and the United Kingdom allowing for rapid enrollment and expedited transition into Phase II trials. Among the trial's objectives: assessment of the safety profile of the combination of cisplatin and CA4P, preliminary evidence of efficacy and to determine the recommended Phase II dose. This Phase I trial has been approved by the Danish Medicines Agency and approval is being sought from the regulatory authorities governing the additional sites. "We believe that based upon the strong pre-clinical data, CA4P may lead to a treatment for these advanced and recurrent cervical cancer patients, thus addressing a serious unmet therapeutic need. This research will be a key component to the work we and the NSGO have done and are planning going forward," said Dr. Jacob Lindegaard of the University Hospital of Aarhus. Although incidence of cervical cancer has decreased in the United States since the onset of advanced screening techniques, there were an estimated 470,606 new cases of cervical cancer and an estimated 233,372 deaths due to the disease worldwide in 2000 (GLOBOCAN 2000: Cancer Incidence, Mortality and Prevalence Worldwide, Version 1.0 IARC CancerBase No. 5. Lyon, IARCPress, 2001). About Combretastatin A4P (CA4P) CA4P leads a novel class of drugs called vascular targeting agents (VTAs). CA4P attacks the 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. structure of solid tumors and other diseases characterized by the formation of aberrant 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 compound triggers a change in the shape of the endothelial cells Endothelial cells The cells lining the inner walls of the blood vessels. Mentioned in: Von Willebrand Disease lining the tumor's blood vessels in turn, blocking the flow of blood to the tumor and depriving it of oxygen and nutrients essential to its survival. The Compound is currently in numerous human clinical trials in oncology and ophthalmology involving both single agent and multiple treatment modalities. About OXiGENE, Inc. OXiGENE is an emerging pharmaceutical company developing novel small-molecule therapeutics to treat cancer and eye diseases. The Company's major focus is the clinical advancement of drug candidates that selectively disrupt abnormal blood vessels associated with solid tumor progression and visual impairment Visual Impairment Definition Total blindness is the inability to tell light from dark, or the total inability to see. Visual impairment or low vision is a severe reduction in vision that cannot be corrected with standard glasses or contact lenses and . OXiGENE is dedicated to leveraging its intellectual property position and therapeutic development expertise to bring life saving and enhancing medicines to patients. 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 Certain statements in this news release concerning OXiGENE's business are considered "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: the ability of the study of CA4P in combination with cisplatin in cervical cancer to rapidly enroll patients and have an expedited transition into Phase II trials; CA4P's potential to significantly improve clinical benefits in multiple modalities and cancer indications; and the use of CA4P as a potential treatment for advanced and recurrent cervical cancer. 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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