Antigenics Reports Significant Data from Pilot Study Combining Personalized Cancer Vaccine with Gleevec in Leukemia; Clinical Findings Lead to Phase II Trial.Business Editors & Health/Medical Writers BIOWIRE2K NEW YORK--(BUSINESS WIRE)--Dec. 17, 2002 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) today reported interim results from an ongoing pilot study of AG-858, its personalized 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. 70 (HSP (Hosting Service Provider) An organization that specializes in hosting Web sites. There are various levels of offerings from sharing a Web server with several other companies to having a dedicated Web server or to providing co-location services. See co-location. 70) product, in combination with Gleevec(TM) (imatinib mesylate, Novartis) for treatment of chronic myeloid leukemia (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 . Marking the first clinical experience with AG-858, five out of five evaluable patients showed objective clinical responses in the trial, including two patients who had complete molecular responses. Based on these encouraging data, Antigenics plans to initiate a Phase II study to further assess the efficacy of this combination therapy. "We have now seen objective responses using our personalized HSP products in patients with CML, melanoma and kidney cancer who had little or no other treatment options available," said Garo H. Armen Garo H. Armen is chairman and chief executive officer of Antigenics Inc., the biotechnology company he cofounded with Pramod Srivastava in 1994. From mid-2002 through 2004, he was chairman of the board of directors for the biopharmaceutical company Elan Corporation plc. Dr. , PhD, chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Antigenics. "Clearly, the cumulative data give us much confidence going forward." In the pilot study, Zihai Li, MD, PhD, and colleagues at the University of Connecticut The University of Connecticut is the State of Connecticut's land-grant university. It was founded in 1881 and serves more than 27,000 students on its six campuses, including more than 9,000 graduate students in multiple programs. UConn's main campus is in Storrs, Connecticut. School of Medicine found that the combined treatment was associated with the complete elimination of leukemia cells in two of the five chronic phase CML patients evaluated, as determined by polymerase chain reaction polymerase chain reaction (pŏl`ĭmərās') (PCR), laboratory process in which a particular DNA segment from a mixture of DNA chains is rapidly replicated, producing a large, readily analyzed sample of a piece of DNA; the process is (PCR PCR polymerase chain reaction. PCR abbr. polymerase chain reaction Polymerase chain reaction (PCR) ), the most sensitive measure available to detect the presence of leukemia cells. Based on previous reports, only 10 percent of patients treated with Gleevec alone achieve responses using these same criteria. The three remaining patients evaluated were determined to be responders using other measures - including two who showed cytogenetic cytogenetic /cy·to·ge·net·ic/ (-je-net´ik) 1. pertaining to chromosomes. 2. pertaining to cytogenetics. cytogenetic pertaining to or originating from the origin and development of the cell. response, one of the criteria used in the approval of Gleevec. Four of the five patients in the study were determined to be unresponsive to treatment with Gleevec alone. "Gleevec controls blood counts in most CML patients but fewer than 10 percent are PCR-negative. By eliminating all of the CML cells, combination treatment with Gleevec and HSP70 vaccine opens up the possibility of a cure," said Jonathan J. Lewis, MD, PhD, chief medical officer of Antigenics. Like Antigenics' lead product Oncophage(R) (HSPPC-96), AG-858 is a personalized cancer vaccine based on Antigenics' proprietary heat shock protein technology. Derived from each patient's blood, 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 to target and destroy only the cells bearing this fingerprint. About Chronic Myeloid Leukemia Chronic myeloid 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 myeloid leukemia in the United States this year. CML mainly affects adults and is slightly more common in men than women. About Antigenics Antigenics' mission is to enhance and extend lives through the development of superior health care products for a wide range of cancers, infectious diseases, and autoimmune and degenerative disorders. The company's lead product is Oncophage, a personalized cancer vaccine in Phase III trials and granted fast track and orphan drug designations by the US Food and Drug Administration for kidney cancer and melanoma. Antigenics' cancer portfolio also includes AG-858, a personalized cancer vaccine in Phase I development for chronic myeloid leukemia, and two Phase II liposomal products: Aroplatin(TM), a third-generation platinum chemotherapeutic, and ATRA-IV, a form of vitamin A. Other products in development include QS-21, an immunomodulator being tested in several advanced clinical vaccine programs in partnership with leading pharmaceutical companies, and AG-702, a genital herpes immunotherapeutic agent in Phase I testing. For more information about Antigenics, please visit www.antigenics.com. This press release contains forward-looking statements, including the statements regarding the timing for initiating an expanded study and the potential that the combination treatment will prove effective in a larger study, and development of HSP70 for chronic myeloid leukemia. 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 enroll sufficient numbers of patients in clinical trials to demonstrate statistically significant results; that we may be unable to obtain the regulatory approvals necessary to conduct additional clinical trials or to market HSP70 alone or in combination with Gleevec for the treatment of chronic myeloid leukemia; 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 Quarterly Report on Form 10-Q 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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