CancerVax Resumes Enrollment in Phase 3 Clinical Trials of the CANVAXIN-TM- Therapeutic Cancer Vaccine For Melanoma.Business Editors/Health/Medical Writers BIOWIRE2K CARLSBAD, Calif.--(BUSINESS WIRE)--April 15, 2003 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. Releases CANVAXIN(TM) Vaccine From Partial Clinical Hold CancerVax Corporation announced today that it will resume patient enrollment in its two international Phase 3 clinical trials of the CANVAXIN(TM) therapeutic cancer vaccine for the post-surgical treatment of patients with Stage III or Stage IV melanoma. The U.S. Food and Drug Administration (FDA) informed the Company that its submission of additional information related to the production, testing, and characterization of the CANVAXIN(TM) vaccine is satisfactory and that the partial clinical hold has been lifted. "This action by the FDA will allow CancerVax to move forward rapidly with our Phase 3 clinical trials of the CANVAXIN(TM) vaccine in the treatment of patients with advanced-stage melanoma," said David F. Hale, 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. of CancerVax. "Our interactions with the FDA have been very positive and productive. We will continue to work cooperatively with the FDA to make progress towards a license application for the CANVAXIN(TM) vaccine. We anticipate that this process will be expedited by the Fast Track designation recently granted by the FDA for the CANVAXIN(TM) vaccine." The Fast Track designation allows CancerVax the opportunity for increased interactions with FDA staff, and the potential for priority review of a license application should the CANVAXIN(TM) vaccine prove to be safe and effective in clinical trials for the post-surgical treatment of 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. melanoma. The CANVAXIN(TM) vaccine is being evaluated in two international, 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. , double-blind, placebo-controlled Phase 3 clinical trials. The partial clinical hold on new patient enrollment was not the result of any clinical practice or safety concerns related to the CANVAXIN(TM) vaccine. Patients in the two Phase 3 clinical trials who were already receiving the CANVAXIN(TM) vaccine were permitted to continue to do so. The CANVAXIN(TM) vaccine has been supplied to these patients without interruption. "We believe that resuming enrollment in these trials is welcome news for our clinical investigators and most importantly, for patients with melanoma and their families who have been anxiously waiting for these Phase 3 clinical trials to re-open," said Hale. About Melanoma Melanoma is the deadliest form of skin cancer. New cases of melanoma in the U.S. have doubled over the past 30 years, and 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, estimates that in 2003 there will be 54,200 new cases of melanoma and 7,600 deaths in the U.S. alone. While melanoma is curable cur·a·ble adj. Capable of being cured or healed. in most patients when identified and treated in its earliest stages, patients with melanoma that has metastasized (spread to other parts of the body) have a poor prognosis for long-term survival. Even after surgery and current treatment, only 10-50% of patients with metastatic melanoma survive five years. According to the American Cancer Society, the lifetime risk of malignant melanoma Malignant Melanoma Definition Malignant melanoma is a type of cancer arising from the melanocyte cells of the skin. Melanocytes are cells in the skin that produce a pigment called melanin. in the U.S. has risen from 1/1,500 people in 1935 to 1/74 people in 2000, with a forecast of 1/50 people by 2005. About CANVAXIN(TM) CancerVax's patented, core technology is based on the development of allogeneic allogeneic /al·lo·ge·ne·ic/ (-je-ne´ik) 1. having cell types that are antigenically distinct. 2. in transplantation biology, denoting individuals (or tissues) that are of the same species but antigenically , whole-cell cancer vaccines Cancer vaccines A treatment that uses the patient's immune system to attack cancer cells. Mentioned in: Pancreatic Cancer, Exocrine , which express multiple antigens that are associated with melanoma and other solid tumors. The experimental CANVAXIN(TM) therapeutic cancer vaccine is composed of three allogeneic tumor cell lines that together express over 30 tumor- or melanoma-associated antigens. Although the vaccine's mechanism of action has not been established, research indicates that the antigens expressed in the CANVAXIN(TM) vaccine stimulate the body's own 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. to produce cancer-fighting T cells T cells A type of white blood cell produced in the thymus gland. T cells are an important part of the immune system. Infants born with an underdeveloped or absent thymus do not have a normal level of T cells in their blood. and antibodies. The polyvalent polyvalent /poly·va·lent/ (-va´lent) multivalent. pol·y·va·lent adj. 1. Acting against or interacting with more than one kind of antigen, antibody, toxin, or microorganism. 2. (multiple antigen) nature of the CANVAXIN(TM) vaccine confers a high probability of an antigenic match with individual patients with melanoma and other solid tumors. The CANVAXIN(TM) vaccine has been administered to more than 2,600 cancer patients in clinical trials and appears to be well-tolerated. It 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 and Fast Track designations from the FDA for the treatment of metastatic melanoma. About CancerVax Corporation (www.cancervax.com) CancerVax Corporation is a privately held biotechnology company focused on the research, development and commercialization of biological products for the treatment and control of cancer. The Company's lead product candidate, the CANVAXIN(TM) therapeutic cancer vaccine, is currently being evaluated in two international Phase 3 clinical trials for the treatment of advanced-stage melanoma. CancerVax also plans to evaluate the CANVAXIN(TM) vaccine in the treatment of 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. and develop additional therapeutic vaccines for other types of cancers. The Company has additional product candidates in preclinical development for the treatment of cancer, 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 headquarters in Carlsbad, California, 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 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 Corporation. |
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