CancerVax Places Hold On New Patient Enrollment in Melanoma Trials; Patients Currently Enrolled or Already Pre-Qualified for Clinical Trials to Continue Treatment Without Interruption.Business Editors and Health/Medical Writers CARLSBAD, Calif.--(BW HealthWire)--May 2, 2002 CancerVax Corporation(R) announced today that it has placed a hold on the enrollment of new patients in its Phase 3 clinical trials phase 3 clinical trial Phase 3 study. See Phase study. for CANVAXIN(TM), its therapeutic cancer vaccine The term cancer vaccine is often used to describe a process whereby a person's immune system is coaxed into recognizing and destroying malignant cells without harming normal cells. , for the treatment of Stage III and Stage IV melanoma. The United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (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 asked the Company to provide certain information related to the production, characterization and testing of the CANVAXIN(TM) vaccine. The hold on new patient enrollment is not the result of any clinical practice or safety concerns related to the CANVAXIN(TM) vaccine. The FDA indicated that patients in the two Phase 3 clinical trials who are already receiving the CANVAXIN(TM) vaccine should be permitted to continue to do so. The CANVAXIN(TM) vaccine will be supplied to these patients without interruption. Additionally, a small number of patients may be entered into the clinical trials if they have met specific eligibility criteria as of April 25, 2002. "Our first priority is to reassure the patients and clinical investigators who are participating in our clinical trials," said David F. Hale, Chief Executive Officer of CancerVax. "The FDA is allowing continued use of the CANVAXIN(TM) vaccine in patients currently enrolled in the trials. Our immediate goal is to develop the manufacturing-related information requested by the FDA. CancerVax is committed to fully resuming patient enrollment in our ongoing Phase 3 clinical trials as quickly as possible," Hale added. Last year, the Company completed construction of its new manufacturing facility, which is currently operational. The Company designed the facility to provide the CANVAXIN(TM) vaccine for use in clinical trials and with the production capacity to satisfy potential commercial demand, if the CANVAXIN(TM) vaccine is approved by regulatory authorities. The Phase 3 clinical trials are designed to provide pivotal clinical data to support the regulatory submissions for the CANVAXIN(TM) vaccine for approval to market in the U.S. and in other countries. About CancerVax Corporation (www.cancervax.com) CancerVax Corporation is a privately held biotechnology company focused on the research, development and commercialization of novel therapeutic cancer vaccines Cancer vaccines A treatment that uses the patient's immune system to attack cancer cells. Mentioned in: Pancreatic Cancer, Exocrine , angiogenesis inhibitors and monoclonal antibodies This is a list of monoclonal antibodies, antibodies which are clones of a single parent cell. When used as medications, the generic names end in -mab (see "Nomenclature of monoclonal antibodies"). for the treatment and control of cancer. The Company's lead product candidate, CANVAXIN(TM), is a therapeutic cancer vaccine currently being studied for the treatment of advanced-stage melanoma and advanced-stage colon cancer colon cancer, cancer of any part of the colon (often called the large intestine). Colon cancer is the second most common cancer diagnosed in the United States. . CancerVax has additional product candidates in pre-clinical development Pre-clinical development is a stage in the development of a new drug that begins before clinical trials (testing in humans) can begin, and during which important safety and pharmacology data is collected. for the treatment of solid tumor cancers, including several monoclonal antibodies that appear to inhibit angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization. an·gi·o·gen·e·sis n. , the blood vessel blood vessel n. An elastic tubular channel, such as an artery, a vein, a sinus, or a capillary, through which the blood circulates. blood vessel(s), n the network of muscular tubes that carry blood. development that is necessary for tumor growth. CancerVax maintains its corporate and R&D headquarters in Carlsbad, California Carlsbad is a coastal resort-town in northern San Diego County, California. According to the state Department of Finance, the city had a total population of 90,271 in 2003. , and its biologics manufacturing facility in Los Angeles, California. CancerVax cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by CancerVax that any of its plans will be achieved. Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in CancerVax's business including, without limitation, statements about: the progress and timing of its clinical trials; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing its products; unexpected adverse side effects Side effects Effects of a proposed project on other parts of the firm. or inadequate therapeutic efficacy of its products that could delay or prevent product development or commercialization, or that could result in recalls or product liability claims; the scope and validity of patent protection for its products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. All forward-looking statements are qualified in their entirety by this cautionary statement and CancerVax undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. CancerVax(R) and CANVAXIN(TM) are trademarks of CancerVax(R) Corporation. |
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