Antigenics Begins 120-Patient Phase II Trial of AG-858 Cancer Vaccine in Chronic Myelogenous Leukemia.Business Editors/Health/Medical Writers BIOWIRE2K NEW YORK--(BUSINESS WIRE)--April 9, 2003 Antigenics Inc. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : AGEN): Trial to Be Conducted at Leading Medical Centers Worldwide Antigenics Inc. (NASDAQ: AGEN) announced today that it has begun a Phase II study evaluating AG-858 personalized cancer vaccine in combination with Gleevec(TM) (imatinib mesylate imatinib mesylate Warning - Hazardous drug! Gleevec, Glivec (UK) Pharmacologic class: Protein-tyrosine kinase inhibitor Therapeutic class: Antineoplastic , Novartis) for treatment of chronic myelogenous leukemia Chronic myelogenous leukemia (CML) Also called chronic myelocytic leukemia, malignant disorder that involves abnormal accumulation of white cells in the marrow and bloodstream. Mentioned in: Bone Marrow Transplantation (CML 1. CML - A query language. ["Towards a Knowledge Description Language", A. Borgida et al, in On Knowledge Base Management Systems, J. Mylopoulos et al eds, Springer 1986]. 2. CML - Concurrent ML. ), a cancer characterized by the proliferation of abnormal white blood cells White blood cells A group of several cell types that occur in the bloodstream and are essential for a properly functioning immune system. Mentioned in: Abscess Incision & Drainage, Bone Marrow Transplantation, Complement Deficiencies . The international clinical trial will evaluate the safety and efficacy of the combination treatment in up to 120 patients with chronic phase CML who are currently receiving Gleevec treatment but have not achieved complete clinical response. "We are highly encouraged by the responses seen in our earlier clinical trial of CML patients receiving AG-858, and are pleased to be initiating a Phase II development program that can be used in support of a biologicals license application filing," said Jonathan J. Lewis, MD, PhD, chief medical officer of Antigenics. "We feel confident that enrollment for the trial can be completed quickly, given the positive findings from the first study and the enthusiasm expressed by CML patients and leading experts alike." The launch of the Phase II study is based on earlier clinical data that demonstrated objective clinical responses associated with combination AG-858 and Gleevec treatment in five out of five patients tested, four of whom were unresponsive to treatment with Gleevec alone. Two of the five patients experienced complete molecular responses - a result achieved by fewer than 10 percent of patients treated with Gleevec alone, according to published reports. Updated findings from the earlier study will be announced in an oral presentation at this year's annual meeting of 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. in June. Like Antigenics' lead product Oncophage(R) (HSPPC-96), AG-858 is a personalized cancer vaccine based on the company's proprietary heat shock protein heat shock protein n. Any of a group of cellular proteins that are produced under conditions of heat stress and help to stabilize other cellular proteins exposed to high temperatures. technology. Derived from each patient's blood cells blood cells, n.pl the formed elements of the blood, including red cells (erythrocytes), white cells (leukocytes), and platelets (thrombocytes). blood cells See erythrocyte and leukocyte. Platelets are classed separately. , the vaccine is designed to capture the 'antigenic fingerprint' of the patient's particular cancer to reprogram re·pro·gram tr.v. re·pro·grammed or re·pro·gramed, re·pro·gram·ming or re·pro·gram·ing, re·pro·grams To program again. re the body's immune system immune system Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders. to target and destroy only the cancerous cells bearing this fingerprint. About Chronic Myelogenous Leukemia Chronic myelogenous leukemia is a cancer of the blood and bone marrow characterized by overproduction o·ver·pro·duce tr.v. o·ver·pro·duced, o·ver·pro·duc·ing, o·ver·pro·duc·es To produce in excess of need or demand. o of white blood cells. The disease is caused by a genetic mutation that produces an abnormal enzyme (Bcr-Abl tyrosine kinase). Approved in 2001 for CML, Gleevec specifically blocks the action of this abnormal enzyme. The American Cancer Society American Cancer Society, n.pr established in 1913, this national volunteer-based health organization is committed to the elimination of cancer through prevention and treatment and to diminishing cancer suffering through advocacy, scholarship, research, estimates that there will be about 4,400 new cases of chronic myelogenous leukemia in the United States this year. CML mainly affects adults and is slightly more common in men than women. About Antigenics Antigenics is developing personalized immunotherapeutics and revolutionary treatments for cancers, infectious diseases and autoimmune disorders. The company's lead product is Oncophage, a late-stage, personalized cancer vaccine being evaluated in several indications, including kidney cancer and 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. Antigenics' portfolio also includes AG-858, a personalized cancer vaccine in Phase II development; Aroplatin and ATRA-IV, two Phase II liposomal chemotherapeutics; and AG-702/AG-70X, a Phase I genital herpes immunotherapeutic. For more information about Antigenics, please visit www.antigenics.com. This press release contains forward-looking statements, including the statements regarding the sites at which the trial will be conducted; that the 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 AG-858 for chronic myelogenous leukemia will provide adequate data to support a biologicals licensing application filing; that trial enrollment will be completed quickly; and the number of projected new cases of CML this year. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements. These risks and uncertainties include, among others, that we may not be able to initiate the trial at sufficient sites to meet our enrollment expectations and our expectations regarding the numbers, locations and reputations of participating medical centers; that enrollment rates and total enrollment may not meet our expectations; that the trial may not generate safety and efficacy data that supports a biologicals licensing application filing; estimates regarding the incidence of CML may not be accurate; that budget constraints will limit or slow down our development program in this disease; that we may fail to adequately protect our intellectual property or are determined to infringe on the intellectual property of others; and the factors described in the company's periodic filings with the Securities and Exchange Commission. Please see Exhibit 99.1 of our most recent Annual Report on Form 10-K for a discussion of these and other risk factors. We caution investors not to place undue reliance on the forward-looking statements contained in this document. These statements speak only as of the date of this document, and we undertake no obligation to update or revise the statements. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. |
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