ImClone Systems' Cancer Therapeutic, C225, Enters Phase II Clinical Trial for the Treatment of Patients with Metastatic Renal Cell Carcinoma.NEW YORK--(BW HealthWire)--Dec. 4, 1997--ImClone Systems Incorporated (Nasdaq: IMCL IMCL International Making Cities Livable IMCL Inter Marine Container Lines IMCL International Management Consultants Ltd. IMCL Indraprastha Medical Corp Ltd (India) IMCL Imperial Majesty Cruise Line ) announced today the initiation of a multi-center, open label 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 for the Company's cancer therapeutic, C225. 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 C225 inhibits activity of 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 associated with cancer cell growth in renal cell carcinoma renal cell carcinoma or hypernephroma Malignant tumour of the cells that cover and line the kidney. It usually affects persons over age 50 who have vascular disorders of the kidneys. It seldom causes pain, unless it is advanced. , epidermoid carcinoma, and other cancers. The Phase II trial will evaluate the effect of C225 on time to progression of disease in 53 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. renal cell carcinoma. The study will also measure tumor response rate and survival, as well as pharmacological and safety profiles. "Results of animal studies of C225 in models of renal cell carcinoma have demonstrated a significant increase in the survival rate, as well as decreases in tumor volume," commented Harlan W. Waksal, M.D., Executive Vice President and Chief Operating Officer Chief Operating Officer (COO) The officer of a firm responsible for day-to-day management, usually the president or an executive vice-president. of ImClone Systems. "We believe renal cell carcinoma is an excellent disease target for evaluating the use of C225." ImClone Systems has two oncology products in late stage clinical development and is advancing earlier drug candidates to the clinical stage. The Company is currently studying C225, an epidermal growth factor receptor (EGFr) antagonist, in head and neck cancer patients in three Phase Ib/IIa dose-escalation trials in combination with other anti-cancer therapies, including chemotherapy and radiation. ImClone expects to initiate additional Phase II/III studies to evaluate the potential of C225 in various tumor types. ImClone's other late stage clinical development program is an anti-cancer vaccine, BEC2. ImClone and its corporate partner, Merck KGaA, intend to initiate a Phase III multinational trial to study BEC2 in small cell lung cancer Lung Cancer, Small Cell Definition Small cell lung cancer is a disease in which the cells of the lung tissues grow uncontrollably and form tumors. Description Lung cancer is divided into two main types: small cell and non-small cell. patients. In preclinical research, the Company is evaluating the therapeutic potential of its anti-FLK-1/KDR monoclonal antibody as an anti-angiogenic agent especially against tumors known to secrete vascular endothelial growth factor Vascular endothelial growth factor (VEGF) is an important signaling protein involved in both vasculogenesis (the de novo formation of the embryonic circulatory system) and angiogenesis (the growth of blood vessels from pre-existing vasculature). . ImClone Systems Incorporated, headquartered in New York, is a biopharmaceutical company developing novel therapeutic products including interventional therapeutics, cancer vaccines and blood cell growth factors for the treatment of cancer and cancer-related disorders. Except for the historical information contained herein, the matters discussed in this news release may include forward-looking statements. Actual results may differ materially from those predicted in such forward-looking statements due to the risks and uncertainties inherent in the Company's business, including, without limitation, risks and uncertainties in obtaining and maintaining regulatory approval, market acceptance of and continuing demand for the Company's products, the impact of competitive products and pricing, and the Company's ability to obtain additional financing to support its operations. The Company undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. CONTACT: ImClone Systems Incorporated Andrea F. Rabney Director of Corporate Development and Investor Relations (212) 645-1405 or Burns McClellan, Inc. Reagan Codner (investors) Justin Jackson (media) (212) 213-0006 |
|
||||||||||||||
Printer friendly
Cite/link
Email
Feedback
Reader Opinion