ViRexx Announces Enrollment Completion of Ovarex'R' MAb Phase III Trial for Ovarian Cancer.EDMONTON, Alberta -- ViRexx Medical Corp. (TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension :VIR VIR Virtual VIR Virgin Islands (ISO Country code) VIR Virginia International Raceway VIR Vascular and Interventional Radiology VIR Vehicle Inspection Report VIR Virtual Interface (Alteon) ) a company focused on immunotherapy treatments for certain cancers, chronic hepatitis Chronic hepatitis Long lasting inflammation of the liver due to viruses or other causes. Mentioned in: Tube Compression of the Esophagus and Stomach chronic hepatitis B & C and embolotherapy treatments for tumors, announced today that enrollment has been completed for the first of two identical Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA trials for OvaRex(R) MAb, IMPACT I and IMPACT II. The IMPACT I Phase III trial reached its target enrollment of 177 patients with stage III/IV advanced ovarian cancer ovarian cancer Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast who have successfully completed front-line therapy. "OvaRex(R) MAb represents a potential new standard of care for ovarian cancer patients who endure a five-year survival five-year survival Epidemiology The timespan that a person survives with a particular dread disease, in particular CA; 5YS facilitates standardization of survival statistics. See Cancer-free survival. rate of only 31%. There have been no recent innovations in the treatment of ovarian cancer. Completing enrollment in the first of two Phase III trials is a major milestone toward the commercialization of this important product," said Dr. Lorne Tyrrell, Chief Executive Officer of ViRexx. "With enrollment complete in the first trial, we now await the clinical data from both pivotal trials to confirm this product's therapeutic potential." The OvaRex(R) MAb trials are being conducted and funded by ViRexx's licensing partner Unither Pharmaceuticals, Inc., a subsidiary of United Therapeutics. Two identical Phase III double-blind placebo controlled trials are currently being conducted at over 60 sites across the United States. Unither reports the IMPACT II trial continues to enroll patients. The enrollment target for each trial is 177 patients, randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. 2:1 OvaRex(R) MAb versus placebo. The primary endpoint for each trial is time-to-relapse comparing OvaRex(R) MAb and placebo with relapse as the endpoint. "I would like to congratulate our licensing partner United Therapeutics on this important milestone. United recognized the potential of OvaRex(R) MAb and the subsequent agreement has benefited both companies. United's ability to initiate and conduct a trial in a professional, ethical and timely manner illustrates the value of working with strong partners," said Dr. Tyrrell. About OvaRex(R) MAb OvaRex(R) MAb-B43.13 (oregovomab), is 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 developed by ViRexx that has a high degree of specificity to a tumor associated antigen (CA125) that is over-expressed by the majority of late-stage ovarian cancer patients. OvaRex(R) MAb has received both 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 Designation and Fast Track status by the U.S. Food and Drug Administration. Each year approximately 22,000 new cases are diagnosed and approximately 16,000 women die from ovarian cancer in the United States according to estimates from 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, . Although most patients initially respond to surgery and chemotherapy, the relapse rate is estimated to be approximately 85%. Once relapse occurs there is no known curative therapy. About AIT(TM) Platform Technology Certain tumor associated antigens are expressed almost exclusively on cancer cells and are ideal targets for antibodies that act as immunotherapeutic agents. These tumor specific antigens are self produced and thus are not typically recognized as harmful by a patient's immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. . In some cases they actively inhibit immune responses. ViRexx's AIT(TM) Technology induces the immune system to recognize and respond to the cancer antigen. ViRexx antibodies work to reprogram re·pro·gram tr.v. re·pro·grammed or re·pro·gramed, re·pro·gram·ming or re·pro·gram·ing, re·pro·grams To program again. re the immune system to recognize specific "cancer" antigens as "foreign", triggering the immune system to effectively respond to and attack their antigens and their associated cancers. The resulting response employs both the humoral and cellular arms of the immune system. About ViRexx Medical Corp. ViRexx is an Edmonton, Alberta based biotechnology company focused on the development of novel therapeutic products for the treatment of certain cancers and specified chronic viral infections. ViRexx's most advanced programs include drug candidates for the treatment of ovarian cancer, chronic hepatitis B and C and solid tumors. ViRexx's lead product candidate, OvaRex(R) MAb, a therapy for the treatment of late-stage ovarian cancer, is currently the subject of two Phase III clinical trials being funded by ViRexx's licensing partner Unither Pharmaceuticals, Inc., a subsidiary of United Therapeutics Corporation. For additional information about ViRexx, please see www.virexx.com. This news release contains certain forward-looking statements that reflect the current views and/or expectations of the Company with respect to its performance, business and future events. Such statements are subject to a number of risks, uncertainties and assumptions. Actual results and events may vary significantly. The TSX has not approved or disapproved of the information contain ed herein ViRexx Medical Corp. (TSX:VIR) |
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