PRAECIS PHARMACEUTICALS INCORPORATED Study Results Published at the American Society of Clinical Oncology Annual Meeting.Business Editors/Health/Medical Writers WALTHAM, Mass.--(BUSINESS WIRE)--May 31, 2003 PRAECIS PHARMACEUTICALS INCORPORATED (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 : PRCS PRCS Palestine Red Crescent Society PRCS Permit Required Confined Space PRCS Primary Reaction Control System PRCS Senior Chief Parachute Rigger (Naval Rating) PRCS Pseudorandom Chip Stream PRCS Project Revision Control System ) today announced that results from its clinical study of Plenaxis(TM) (abarelix for injectable suspension) in the treatment of advanced, symptomatic prostate cancer were published in the 39th Annual 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) "Meeting Proceedings." The Company previously reported results from this clinical study in February 2003. The two abstracts published today include data relating to the avoidance of surgical castration and reduction in pain and the use of pain medication, as well as 48-week follow-up data not previously reported relating to the anti-cancer response rates seen in advanced, symptomatic prostate cancer patients treated with the Company's investigational therapy, Plenaxis(TM). "The data presented today demonstrates how the novel mechanism of action of Plenaxis(TM), a GnRH antagonist, can work to improve the clinical symptomatology symptomatology /symp·to·ma·tol·o·gy/ (simp?to-mah-tol´ah-je) 1. the branch of medicine dealing with symptoms. 2. the combined symptoms of a disease. symp·to·ma·tol·o·gy n. in advanced prostate cancer patients," stated William K. Heiden, PRAECIS' 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. . "If approved, Plenaxis(TM) could provide an important treatment alternative for certain advanced prostate cancer patients who today have limited therapeutic options." Prostate cancer grows under the influence of the male hormone, testosterone. The goal of treatment is to reduce testosterone rapidly. Today, many advanced, symptomatic prostate cancer patients are destined des·tine tr.v. des·tined, des·tin·ing, des·tines 1. To determine beforehand; preordain: a foolish scheme destined to fail; a film destined to become a classic. 2. for bilateral orchiectomy orchiectomy /or·chi·ec·to·my/ (or?ke-ek´tah-me) excision of one or both testes. If bilateral it is called also castration. or·chi·ec·to·my or or·chi·dec·to·my n. (surgical castration) due to the perceived risks associated with currently available hormonal therapies, known as LHRH LHRH abbr. luteinizing hormone-releasing hormone LHRH Luteinizing hormone-releasing hormone, GnRH, gonadotropin-releasing hormone, LRH, LRF Endocrinology A decapeptide synthesized by hypothalamic neurons which agonists. These therapies induce an initial testosterone surge and may result in worsening symptoms. In contrast, GnRH antagonists have been shown to rapidly reduce testosterone levels while avoiding the initial testosterone surge characteristic of LHRH agonists. The Company resubmitted its New Drug Application (NDA (Non Disclosure Agreement) An agreement signed between two parties that have to disclose confidential information to each other in order to do business. In general, the NDA states why the information is being divulged and stipulates that it cannot be used for any ) for Plenaxis(TM) to the United States Food and Drug Administration United States Food and Drug Administration (FDA), n.pr a unit of the Public Health Service created to protect the health of the nation against impure and unsafe foods, drugs, and cosmetics. (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) on February 27, 2003. The Company is seeking approval to market Plenaxis(TM) in the United States for use in a defined sub-population of advanced prostate cancer patients for whom the use of existing hormonal therapies may not be appropriate. The Company expects to receive a response from the FDA regarding the approvability of its NDA by August 27, 2003. PRAECIS PHARMACEUTICALS INCORPORATED is a biotechnology company focused on the discovery and development of pharmaceutical products using its proprietary LEAP(TM) (Ligand Evolution to Active Pharmaceuticals) technology. LEAP(TM) combines the power of biological selection with the advantages of medicinal chemistry in a unique molecular evolution process. PRAECIS employed LEAP(TM) in the development of Plenaxis(TM), its candidate for the treatment of hormonally responsive advanced prostate cancer and endometriosis. PRAECIS also has clinical programs in Alzheimer's disease and non-Hodgkin's lymphoma, and has other programs in the research or preclinical development stage. This news release contains forward-looking statements, including, but not limited to, statements regarding the re-filing of and continued regulatory review by the United States Food and Drug Administration (FDA) of a New Drug Application for Plenaxis(TM) for the treatment of a defined sub-population of advanced prostate cancer patients. These statements are based on the Company's current beliefs and expectations as to future outcomes. Such statements are subject to numerous factors and uncertainties. These include, but are not limited to, the timing and content of decisions made by the FDA, unexpected results in ongoing and future clinical or preclinical trials and related analyses, and the need for additional research and testing, including as a result of unanticipated determinations by the FDA, as well as the risks set forth from time to time in the Company's filings with the Securities and Exchange Commission, including but not limited to the risks discussed in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2003. The Abstracts referenced are titled: (#104072) Abarelix (ABX), a GnRH Antagonist, for the Initial Treatment of Advanced Prostate Cancer Patients (PCPts) - Long Term Follow Up of Anti-Cancer Response Rates (ACR See riser card. ) and Urinary Symptoms in Study 149-98-04. Koch M, Campion M and Garnick MB for the Abarelix Study Group. Indiana University Medical Center, Indianapolis, IN and PRAECIS Pharmaceuticals, Inc. Waltham MA, USA (Abstract sponsored by Dr. Koch) (#104118) Abarelix (ABX), a GnRH Antagonist, Substantially Reduces Narcotic Analgesic (NA) Requirements and Avoids the Requirement for Bilateral Orchiectomy (BO) in Prostate Cancer Patients (PCPts) with Painful Osseous osseous /os·se·ous/ (os´e-us) of the nature or quality of bone; bony. os·se·ous adj. Composed of, containing, or resembling bone; bony. Metastases (POM). Gaylis F, Campion M and Garnick MB, for the Abarelix Study Group. Center For Urological Research La Mesa, CA, and PRAECIS Pharmaceuticals, Inc. Waltham MA, USA (Abstract sponsored by Dr. Garnick) |
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