Enzon Initiates Phase II Clinical Trial for PROTHECAN.Business & Health Editors PISCATAWAY, N.J.--(BUSINESS WIRE)--July 24, 2001 Enzon, 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 : ENZN) announced today the initiation of patient dosing in 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 for PROTHECAN(R) (PEG-camptothecin) in patients with small-cell lung cancer lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell. . This Phase II trial is an open-label study, that will enroll up to 60 patients and evaluate the anti-tumor activity of PROTHECAN. The Company expects to initiate additional Phase II trials in non-small cell lung and other cancers with PROTHECAN as both a single-agent and in combination with other oncolytic agents. The pharmacokinetic data from ongoing Phase I clinical trials of PROTHECAN show that biologically relevant plasma concentrations of free camptothecin are sustained for up to 168 hours after a single dose of PROTHECAN and anti-tumor activity has been observed. PROTHECAN is a PEG-enhanced version of a small molecule called camptothecin, which is an anti-cancer compound in the class of drugs called topoisomerase topoisomerase an enzyme involved in DNA replication that introduces a single-strand nick in the DNA enabling it to swivel and thereby relieve the accumulated winding strain generated during unwinding of the double helix. I inhibitors. Camptothecin, which was originally studied at the National Institutes of Health, is a potent topoisomerase inhibitor. For many years camptothecin has been known to be a very effective oncolytic agent, but drug delivery problems have limited its use. Two camptothecin derivatives, topotecan and irinotecan, have been approved by the 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. for the treatment of small-cell lung and colorectal cancers, respectively. While these two products are more soluble than camptothecin, their efficacy rate is relatively limited. Despite their limitations, these two products together achieved 2000 worldwide sales of approximately $580 million. Enzon is a biopharmaceutical company developing advanced therapeutics for life-threatening diseases through the application of its proprietary drug delivery and targeting technologies, PEG Modification, Pro Drug/Transport technology and Single-Chain Antigen-Binding(SCA (Single Connector Attachment) An 80-pin plug and socket used to connect peripherals. With a SCSI drive, it rolls three cables (power, data channel and ID configuration) into one connector for fast installation and removal. (R)) protein technology. Three products are currently marketed which utilize Enzon's technology: PEG-INTRON marketed by Schering-Plough for hepatitis C, ONCASPAR(R) for Acute Lymphoblastic Leukemia acute lymphoblastic leukemia n. Abbr. ALL Lymphoblastic leukemia occurring mainly in older adults, characterized by rapid onset and progression of symptoms. Also called acute lymphocytic leukemia. (ALL), and ADAGEN(R) a treatment for a form of Severe Combined Immunodeficiency Disease Noun 1. severe combined immunodeficiency disease - a congenital disease affecting T cells that can result from a mutation in any one of several different genes; children with it are susceptible to infectious disease; if untreated it is lethal within the first year or (SCID SCID severe combined immunodeficiency (disease); see under immunodeficiency. SCID abbr. severe combined immunodeficiency SCID severe combined immunodeficiency disease. ), commonly known as the "Bubble Boy Disease." In addition to three approved products, Enzon has several products in various stages of clinical development by itself and with partners, including additional indications for PEG-INTRON with Schering-Plough. A Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the is being conducted for PEG-INTRON for the treatment of malignant melanoma. Enzon develops and markets products on its own and through strategic alliances, which in addition to Schering-Plough Corporation, include Alexion Pharmaceuticals, Inc., Baxter Healthcare Corporation, Bristol-Myers Squibb Company, Eli Lilly & Company, and Aventis. Except for the historical information herein, the matters discussed in this news release include forward-looking statements that may involve a number of risks and uncertainties. Actual results may vary significantly based upon a number of factors which are described in the Company's Form 10-K/A, Form 10-Q's and Form 8-Ks on file with the SEC, including without limitation, risks in obtaining and maintaining regulatory approval for indications and expanded indications, market acceptance of and continuing demand for Enzon's products and the impact of competitive products and pricing. This release is also available at http://www.enzon.com |
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