Abgenix Announces Initiation of Phase II Clinical Trial of ABX-EGF in Colorectal Cancer.Business Editors/Health & Medical Writers FREMONT, Calif.--(BW HealthWire)--Dec. 27, 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 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. . 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 third Phase II study of ABX-EGF, is designed to assess the safety and efficacy of ABX-EGF as monotherapy 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 who have previously failed chemotherapy. ABX-EGF is being developed in collaboration with Immunex Corporation. This multi-center, open-label Phase II study will enroll up to 100 patients. Patients will receive intravenous infusions of 2.5 mg/kg of ABX-EGF weekly over an 8-week treatment cycle, for up to 6 cycles. "We are pleased to advance our clinical oncology program with the start of this third Phase II trial for ABX-EGF," stated R. Scott Greer, chairman and chief executive officer of Abgenix. "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 show that it is well tolerated and shows biological activity at low doses. Thus far, three patients in the Phase I study have achieved stable disease/minor response. Other Phase II 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. and 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. 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 cells once believed to be peculiar to cancers, but now know to be epithelial cells differing in no respect from those found elsewhere in the body, and distinguished only by peculiarity of location and grouping. See also: Cancer 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 regimen with irinotecan plus fluorouracil fluorouracil: see metabolite. and leucovorin is currently the standard first-line treatment 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. |
|
||||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion