Abgenix Files IND Application for ABX-MA1 in Melanoma.Business/Health Editors FREMONT, Calif.--(BW HealthWire)--Jan. 7, 2002 Abgenix, Inc. (Nasdaq: ABGX) announced today the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (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. ) to initiate Phase I clinical trials of ABX-MA1, a fully human 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 candidate generated with the company's XenoMouse(R) technology, for the 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, a serious form of skin cancer. ABX-MA1 targets a protein called MUC MUC Mount Union College (Ohio) MUC Multi User Chat MUC Message Understanding Conference MUC Montreal Urban Community MUC Malaspina University College (Canada) 18, a cell surface adhesion molecule that is highly expressed on metastatic melanoma cells but not on normal skin cells. MUC18 has been demonstrated to play a critical role in melanoma growth and metastasis metastasis /me·tas·ta·sis/ (me-tas´tah-sis) pl. metas´tases 1. transfer of disease from one organ or part of the body to another not directly connected with it, due either to transfer of pathogenic microorganisms or to by regulating the adhesion and interaction between melanoma cells and surrounding skin cells and new 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. cells. In pre-clinical studies, binding of the MUC18 antigen by ABX-MA1 inhibited primary melanoma tumor growth and the formation of tumor metastases Metastasis (plural, metastases) A tumor growth or deposit that has spread via lymph or blood to an area of the body remote from the primary tumor. Mentioned in: Malignant Melanoma . MUC18 is also expressed on sarcomas Sarcomas Definition A sarcoma is a bone tumor that contains cancer (malignant) cells. A benign bone tumor is an abnormal growth of noncancerous cells. Description A primary bone tumor originates in or near a bone. , including smooth muscle and blood vessel-derived sarcomas, prostate and renal cell cancers. "We had set a goal of submitting an IND for a new Abgenix proprietary product for the year 2001, and we are pleased to announce we have reached this goal," R. Scott Greer, chairman and chief executive officer of Abgenix said. "ABX-MA1 is the fifth XenoMouse-derived antibody to enter clinical trials. Looking to the year ahead, we anticipate increased clinical activity and advancement of our development pipeline with two Abgenix and three collaborator IND filings for 2002." About Melanoma Melanoma is the most serious cancer of the skin. Presently, it is the seventh most common cancer in the United States. The projected 2001 incidence rate in the U.S. is 51,400 and mortality rate is 7,800. Melanoma can spread in the body through the blood and lymphatic system lymphatic system (lĭmfăt`ĭk), network of vessels carrying lymph, or tissue-cleansing fluid, from the tissues into the veins of the circulatory system. . Organ involvement by metastases, most commonly to the lungs and liver, is the leading cause of death from the disease. Melanomas that have not spread beyond the site at which they developed are curable cur·a·ble adj. Capable of being cured or healed. by surgical excision. Melanoma that has spread to distant sites is infrequently curable with surgery, although long-term survival is occasionally achieved by resection of metastasis. Radiation therapy may provide symptomatic relief for metastases to brain, bones and viscera viscera /vis·ce·ra/ (vis´er-ah) plural of viscus. vis·cer·a pl.n. 1. The soft internal organs of the body, especially those contained within the abdominal and thoracic cavities. . Although advanced melanoma is relatively resistant to standard chemotherapy, some biologic therapies, such as interferon alfa and interleukin-2 have been reported to produce a low percentage of objective responses. Abgenix is a biopharmaceutical company focused on the development and commercialization of human therapeutic antibodies. The company's technology platform, which includes XenoMouse(R) and XenoMax(TM) technologies, enables the rapid generation and selection of high affinity, fully human antibody product candidates to a variety of disease targets. Abgenix leverages its leadership position in human antibody technology by building a diversified product portfolio through the development of its own internal proprietary products and through the establishment of licensing arrangements with multiple pharmaceutical, biotechnology and genomics companies. Abgenix's proprietary products are currently in clinical trials for the treatment of cancer and inflammatory diseases. For more information on Abgenix, visit the company's website at www.abgenix.com. Statements made in this press release about ABX-MA1 clinical trials, Abgenix's technology, product development activities and collaborative arrangements other than statements of historical fact, are forward looking statements and are subject to a number of uncertainties that could cause actual results to differ materially from the statements made, including risks associated with the success of clinical trials, the progress of research and product development programs, the regulatory approval process, competitive products, future capital requirements and the extent and breadth of Abgenix's patent portfolio. Please see Abgenix's public filings with the Securities and Exchange Commission for information about risks that may affect Abgenix. |
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