Abgenix Announces Initiation of a Phase 2 Clinical Trial of ABX-EGF in Combination With Chemotherapy in Patients With Colorectal Cancer.Business Editors & Medical/Health Writers FREMONT, Calif.--(BW HealthWire)--Jan. 8, 2002 Abgenix, Inc. (Nasdaq:ABGX) announced today the initiation of a Phase 2 clinical trial phase 2 clinical trial Phase 2 study. See Phase study. of ABX-EGF in patients with 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. . This clinical trial, the fifth Phase 2 study of ABX-EGF and the second for the colorectal cancer indication, is designed to assess the safety and efficacy of ABX-EGF in combination with standard chemotherapy, as first-line treatment A first-line treatment or first-line therapy is a medical therapy recommended for the initial treatment of a disease, sign or symptom, usually on the basis of empirical evidence for its efficacy. in patients with 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. Abgenix is developing ABX-EGF in collaboration with Immunex Corp. ABX-EGF is 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 against the epidermal growth factor receptor This article is about a cell suface receptor. For estimated measure of kidney function (eGFR), see Glomerular filtration rate. The epidermal growth factor receptor (EGFr), a receptor identified in many solid tumor types. The multi-center, open-label Phase 2 study will enroll up to 84 patients. Patients will receive weekly intravenous infusions of 2.5 mg/kg of ABX-EGF in combination with standard doses of irinotecan, leucovorin, and 5-fluorouracil over a 6-week treatment cycle, for up to eight cycles. "For patients with colorectal cancer, we are evaluating ABX-EGF as a monotherapy, as well as in combination with standard chemotherapy in two separate Phase 2 studies," stated R. Scott Greer, chairman and chief executive officer of Abgenix. "We are pleased with the progress the joint Abgenix/Immunex team has made in advancing development of our lead antibody candidate for cancer." Preliminary results of an ongoing Phase 1 clinical trial phase 1 clinical trial Phase 1 study. See Phase study. of ABX-EGF show that it is well tolerated and shows biological activity at low doses. Thus far, three patients in the Phase 1 study have achieved stable disease or minor response. Other Phase 2 studies of ABX-EGF in kidney cancer Kidney Cancer Definition Kidney cancer is a disease in which the cells in certain tissues of the kidney start to grow uncontrollably and form tumors. , non-small cell lung cancer Lung Cancer, Non-Small Cell Definition Non-small cell lung cancer (NSCLC) is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description There are two kinds of lung cancers, primary and secondary. and prostate cancer prostate cancer, cancer originating in the prostate gland. Prostate cancer is the leading malignancy in men in the United States and is second only to lung cancer as a cause of cancer death in men. are currently ongoing. About ABX-EGF ABX-EGF is a fully human monoclonal antibody that targets the epidermal growth factor receptor (EGFr), which is over-expressed on a variety of cancers including lung, breast, bladder, prostate, colorectal, kidney and head and neck cancer. It has been demonstrated that cancer cells can become dependent on growth signals mediated through the EGFr for their survival. In mouse models, ABX-EGF monotherapy has been shown to both eradicate established human tumors and block the growth of human tumors. About Colorectal Cancer Overexpression of the EGFr has been reported to occur in the tumor tissue of 40-70% of colorectal cancer patients. In 2000, there were approximately 57,000 deaths and an estimated 130,000 new cases of colorectal cancer in the United States, making it the second leading cause of death from cancer in North America. Chemotherapy regimens with irinotecan plus fluorouracil fluorouracil: see metabolite. and leucovorin are currently the standard first-line treatments worldwide for metastatic colorectal cancer. However, the median progression free survival with this combination regimen is only seven months and there is a need for more effective therapies. 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-EGF 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 Capital requirements Financing required for the operation of a business, composed of long-term and working capital plus fixed assets. 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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