Abgenix Announces Initiation of Phase II Clinical Trial of ABX-EGF in Non-Small Cell Lung Cancer.Business Editors/Health & Medical Writers FREMONT, Calif.--(BW HealthWire)--July 31, 2001 Abgenix, Inc. (Nasdaq:ABGX) announced today the initiation of a Phase II clinical trial Noun 1. phase II clinical trial - a clinical trial on more persons than in phase I; intended to evaluate the efficacy of a treatment for the condition it is intended to treat; possible side effects are monitored phase II of ABX-EGF in patients with 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. (NSCLC NSCLC non (or cancer). NSCLC Non-small cell lung cancer, see there ). 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. This clinical trial, the second Phase II study of ABX-EGF, will assess the tolerability and efficacy of ABX-EGF in combination with standard chemotherapy in patients with NSCLC. ABX-EGF is being developed in collaboration with Immunex Corporation. This multi-center Phase II study will enroll up to 210 patients across North America. Patients will receive weekly intravenous infusions of ABX-EGF in combination with standard chemotherapy or standard chemotherapy alone. "We are happy to be moving forward with the second Phase II trial this year for ABX-EGF," stated R. Scott Greer, chairman and chief executive officer of Abgenix. "We are pleased with the progress the joint development team has made in advancing clinical development of ABX-EGF in various cancer indications. Our goal is to provide effective, antibody-based therapeutic options for cancer patients." Preliminary results of an ongoing Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I of ABX-EGF were presented at the American Society of Clinical Oncology American Society of Clinical Oncology, or ASCO, is an organization that represents all clinical oncologists. Every year, ASCO holds a large symposium where physicians and researchers meet to convey and discuss research and ideas. (ASCO ASCO American Society of Clinical Oncology ASCO Association of Schools and Colleges of Optometry (since 1941; Rockville, Maryland) ASCO Australian Standard Classification of Occupations ASCO Automatic Switch Company ) annual meeting in May 2001, showing ABX-EGF to be safe and well tolerated. Thus far, two patients in the Phase I study have achieved stable disease. A Phase II study evaluating the safety and efficacy of ABX-EGF as a single agent in patients with 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. was initiated by Abgenix and Immunex earlier this year. 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. Overexpression of the EGFr has been reported to occur in the tumor tissue of 60-80% of NSCLC patients. In 2000, there were approximately 120,000 deaths associated with NSCL NSCL National Superconducting Cyclotron Laboratory (MSU) NSCL National Senior Classical League NSCL National Conference of Standards Laboratories NSCL Networked Supported Collaborative Learning cancer and approximately 125,000 new cases of NSCLC in the United States. Advanced NSCLC is characterized by a response rate of approximately 20-30% and a median survival time of less than one year with standard chemotherapy. Abgenix is a biopharmaceutical company focused on the development and commercialization of fully human monoclonal antibody therapies for a variety of diseases. The company's antibody technology platform, which includes XenoMax(TM) technology, enables the rapid generation and selection of high affinity, fully human antibody product candidates to essentially any disease target appropriate for antibody therapy antibody therapy Clinical immunology Any therapeutic intervention in which a monoclonal or other concentrated antibody is used to manage a condition–eg, cancer or severe infection . Abgenix leverages its leadership position in human antibody technology by building a large and diversified product portfolio through the establishment of licensing arrangements with multiple pharmaceutical, biotechnology and genomics companies and through the development of its own internal proprietary products. 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 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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