OXiGENE's CA4P Becomes First Vascular Targeting Agent to be Combined with Monoclonal Antibody in Human Trials.Business Editors/Health/Medical Writers WALTHAM, Mass.--(BUSINESS WIRE)--Sept. 30, 2003 Company's Lead Compound Enters Clinical Study in Advanced Colorectal Cancer colorectal cancer Malignant tumour of the large intestine (colon) or rectum. Risk factors include age (after age 50), family history of colorectal cancer, chronic inflammatory bowel diseases, benign polyps, physical inactivity, and a diet high in fat. 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) today announced the initiation of a Phase I/II combination trial of its lead anti-cancer agent, 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), and the iodine-labeled antibody A5B7 ((131)I-A5B7), in patients with advanced colorectal cancer. With this study, CA4P is now involved in five concurrent human oncology trials in the United States and Europe. Approximately 35 patients are expected to be recruited for the trial, the world's first human study combining 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) ) with radioimmunotherapy (RIT RIT, n See therapy, regenerative injection. ). The study will be carried out at Mount Vernon and Royal Free Hospitals in the United Kingdom
"This study fulfills one of the key milestones we established early in 2003 - the initiation of additional clinical trials of CA4P aimed at specific cancer indications," said OXiGENE President and Chief Executive Officer Fred Driscoll. "CA4P is now being evaluated as a single agent as well as in separate combination trials with radiotherapy, chemotherapy and, now, a monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing . These combination trials will demonstrate whether CA4P has the potential to significantly enhance the clinical benefit in a variety of approaches to cancer treatment in large disease settings." Independent researchers funded by Cancer Research UK have studied the combination of (131)I-A5B7 and CA4P in human colorectal cancer tumors implanted in mice. Reporting their findings in a study published in the June 2001 issue of the peer-reviewed journal peer-reviewed journal Refereed journal Academia A professional journal that only publishes articles subjected to a rigorous peer validity review process. Cf Throwaway journal. Cancer Research, researchers noted that combining RIT with CA4P "can convert tumor growth inhibition into tumor eradication in mice." While RIT administered alone inhibited tumor growth for approximately 35 days, after which all tumors regrew, the combination of RIT and CA4P produced a significantly greater effect: Tumors were eradicated in 85 percent of mice, with a single tumor regrowing at 97 days. Colorectal cancer is the second leading cause of cancer-related deaths in the United States. In 2003, an estimated 57,100 Americans will die of the disease and 147,500 new cases will be diagnosed, according to The American Cancer Society American Cancer Society, n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research, . "Conventional treatments remain relatively ineffective in curing patients with advanced colorectal cancer, so there is a significant need for novel therapies," said the trial's coordinating investigator, Professor Richard H.J. Begent, M.D., head of the oncology department at Royal Free Hospital in London. "The anti-tumor activity exhibited by the combination of (131)I-A5B7 and CA4P in pre-clinical tests suggests that this is a promising therapeutic strategy for patients with this disease." RIT uses an antibody designed to channel radiation directly to tumors, achieving a targeted therapy. A5B7 belongs to a class of compounds known as "anti-CEA" (carcinoembryonic antigen car·ci·no·em·bry·on·ic antigen n. Abbr. CEA A glycoprotein present in fetal gastrointestinal tissue, generally absent from adult cells with the exception of some carcinomas. ) antibodies because it targets a glycoprotein glycoprotein (glī'kōprō`tēn), organic compound composed of both a protein and a carbohydrate joined together in covalent chemical linkage. known to be present in 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. colorectal cancer. When it is radiolabeled, A5B7 delivers targeted radiation to the tumor. Professor Begent and his team believe that the infusion of (131)I-A5B7, followed by CA4P, might enhance the effect of the radioimmunotherapy by trapping the antibody in the tumor. The study will include patients with CEA-producing tumors in addition to advanced colorectal carcinoma. Tumor response will be evaluated by a variety of radiological methods.
CA4P is involved in the following clinical studies:
Trial Combination Indication
Phase II (Single agent) Anaplastic thyroid cancer
Phase I/II (131)I-A5B7 Colorectal cancer
Phase I/II Radiotherapy Lung, head and neck, prostate
cancer
Phase I/II Carboplatin and Ovarian cancer
paclitaxel
Phase Ib(1) Carboplatin Various solid tumors
Phase I/II (Single agent) Wet age-related macular
degeneration
(1) Patient enrollment has concluded. Drug therapy is still being
administered.
About Cancer Research UK Cancer Research UK (www.cancerresearchuk.org) is the world's largest independent organization dedicated to cancer research, treatment and prevention. CRUK CRUK Cancer Research United Kingdom is the European leader in the development of novel anti-cancer treatments, from their discovery at the benchside to their testing in early clinical trials. The organization funds more than 3,000 researchers in more than 35 cities across the United Kingdom. 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. OXiGENE's lead VTA, Combretastatin A4 Prodrug, has advanced into Phase II and combination clinical trials in cancer patients in the United States and Europe. The investigational compound also is being evaluated in an ophthalmic study in patients with 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. . 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 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: patient enrollment in the Phase I/II combination trial of CA4P in advanced colorectal cancer and other CEA-producing tumors; the ability of CA4P to significantly enhance the clinical benefit in a variety of approaches to cancer treatment in large disease settings; the estimated number of U.S. deaths from colorectal cancer in 2003; the estimated number of new colorectal cancer cases in the U.S. in 2003; the ability of CA4P to enhance the effect of radioimmunotherapy by trapping it in the tumor; the potential of CA4P to complement established cancer therapies; 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. |
|
||||||||||||||||

Printer friendly
Cite/link
Email
Feedback
Reader Opinion