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Enzon Initiates Phase I Clinical Trial for PEG-paclitaxel.


Business/Health & Technology Editors

PISCATAWAY, N.J.--(BUSINESS WIRE)--May 7, 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 I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained
phase I
 for PEG-paclitaxel.

The trial is designed to determine the safety, tolerability, and pharmacology of PEG-paclitaxel in patients with advanced solid tumors and lymphomas. Up to 40 patients will be enrolled in this study.

PEG-paclitaxel is a PEG modified version of paclitaxel paclitaxel /pac·li·tax·el/ (pak?li-tak´sel) an antineoplastic that promotes and stabilizes polymerization of microtubules, isolated from the Pacific yew tree (Taxus brevifolia);  formulated for ease of administration. Preclinical animal studies have demonstrated that PEG-paclitaxel can be dosed at higher levels than TAXOL(R) (paclitaxel), a leading cancer drug. The ability to dose PEG-paclitaxel at higher levels may allow increased efficacy when compared to TAXOL.

TAXOL is a powerful chemotherapeutic agent chemotherapeutic agent An agent used to treat CA, administered in 'regimens'-one or more 'cycles' that combine 3 or more agents over wks; CAs are toxic to any cell with a high rate of proliferation–the CA itself, the GI tract–causing N&V,  with delivery limitations. It is used to treat various types of cancers, including ovarian, breast, non-small cell lung, and AIDS-related Kaposi's sarcoma Kaposi's sarcoma (käp`əshē', kəpō`sē), a usually fatal cancer that was considered rare until its appearance in AIDS patients. . In 2000, sales of TAXOL were reported to be approximately $1.6 billion.

Using Enzon's proprietary PEG technology, scientists at Enzon have modified paclitaxel through the chemical attachment of PEG using a linker designed to deteriorate over time, giving PEG-paclitaxel prodrug attributes. PEG-paclitaxel was designed to be delivered without the need for solubilizing agents or premedications. TAXOL, a commercial formulation of paclitaxel, contains the solubilizing agent CREMOPHOR(R) and patients are required to take premedications prior to treatment to reduce the potential for adverse reactions adverse reactions,
n.pl unfavorable reactions resulting from administration of a local anesthetic; responsible factors include the drug used, concentration, and route of administration.
, which may be caused by CREMOPHOR.

To date, Enzon's PEG technology has been used to create three approved protein therapeutics, including PEG-INTRON(TM), currently marketed by Schering-Plough for the treatment of hepatitis C.PEG-paclitaxel is the second application of Enzon's PEG technology to deliver small organic chemical molecules. PROTHECAN(R), a PEG modified version of the topoisomerase inhibitor camptothecin, is currently in two Phase I clinical trials. PROTHECAN is expected to commence Phase II clinical trials in the near future.

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. PEG-INTRON is in Phase III clinical trials conducted by Schering-Plough for the treatment of malignant melanoma and 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
. 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 www.enzon.com
COPYRIGHT 2001 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2001, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:May 7, 2001
Words:561
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