Printer Friendly
The Free Library
14,581,586 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Enzon to Launch CLEAR II Registry; New Initiative Reinforces Commitment to Improving Antifungal Research and Clinical Outcomes.


Business Editors/Health/Medical Writers/High-Tech Writers

BRIDGEWATER, N.J--(BUSINESS WIRE)--March 24, 2004

Enzon Pharmaceuticals, 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 a major new initiative to build upon the value of its CLEAR(R) (Collaborative Exchange of Antifungal Research) patient registry with the launch of CLEAR II(TM). CLEAR II is a multi-center registry developed by and for clinicians to share and exchange information regarding the clinical course of invasive fungal infections Fungal infections

Several thousand species of fungi have been described, but fewer than 100 are routinely associated with invasive diseases of humans.
 and clinical experience with Enzon's marketed antifungal ABELCET(R) (Amphotericin B Lipid Complex amphotericin B lipid complex Warning - High-alert drug!

Abelcet

Pharmacologic class: Systemic polyene antifungal

Therapeutic class: Antifungal

 Injection), as well as other antifungal agents antifungal agents,
n.pl agents that inhibit, control, or kill fungi. The most common yeastlike fungus occurring in or near the oral cavity is
C. albicans.
.

Enzon's CLEAR database, which was completed in 2000, is one of the most comprehensive registries in fungal disease. CLEAR encompasses prospectively-gathered data from a total of 3,514 patient records, collected in the United States United States, officially United States of America, republic (2005 est. pop. 295,734,000), 3,539,227 sq mi (9,166,598 sq km), North America. The United States is the world's third largest country in population and the fourth largest country in area.  and Canada from 1996 to 2000. The registry was initially designed and administered by a steering committee comprised of national thought leaders in infectious disease Infectious disease

A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions.
, hematology, and oncology, with patient enrollment from over 150 institutions.

The CLEAR database supports the efficacy and safety of ABELCET across a wide spectrum of fungal pathogens (both yeasts and molds) and broad spectrum of patients. Additionally and of particular significance, the CLEAR database also documents the efficacy and safety of ABELCET in rapidly emerging, more difficult to treat and often treatment resistant pathogens such as Fusarium Fusarium

a genus of fungi; some species are plant pathogens and some are opportunistic infectious agents of humans and animals. Many also produce trichothecene toxins which cause poisoning of animals if the infected material, usually stored feed, is eaten.
, Zygomycetes, and Candida. The CLEAR registry reflects the largest known registry in these emerging fungal pathogens.

Together with former steering committee members, clinicians, and other program advisors, Enzon developed CLEAR II. CLEAR II will now take advantage of the speed and flexibility of web-based data collection to provide participating research centers with online, real-time data that will be collected from patients across multiple sites across North America and accessed via a new website, www.clearii.com. Unlike the CLEAR database, which is limited to clinical experience with ABELCET, CLEAR II will also include data on patients treated with other antifungal agents. The Company expects that the enrollment of new patients in the CLEAR II registry will begin during the first half of calendar 2004. The registry will be previewed to clinicians from around the world at the annual scientific meeting, Focus on Fungal Infections (FOFI FOFI Federazione degli Ordini dei Farmacisti Italiani
FOFI Future-Oriented Financial Information
FOFI Focus on the Family Institute
) 14, being held March 24 through March 26 in New Orleans, LA.

"Enzon is committed to the continued expansion of this important initiative and establishing ourselves as a premier partner in antifungal research," said Clarke Atwell, Enzon's vice president of marketing and sales. "By working together with the clinicians who are faced with the challenges of treating these life-threatening infections we feel we have developed an important new tool that will enable the medical community to share real-time data and clinical experiences to help define treatment strategies that ultimately may save more lives."

To assist Enzon with the CLEAR II project, the Company has partnered with La Jolla, California-based ProSanos Corporation.

About Invasive Fungal Infections

Invasive fungal infections are life-threatening complications often affecting patients with compromised immune systems, such as those suffering from cancer, HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. , and recipients of lung or bone marrow transplants bone marrow transplant: see bone marrow. , and others. They can be caused by a multitude of different fungal pathogens that attack the patient's weakened immune system. Effective treatment is critical and can mean the difference between life and death, and often must be initiated even in the absence of a specific diagnosis.

About ABELCET (amphotericin B lipid complex injection)

ABELCET was approved for use by the U.S. Food and Drug Administration (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.
) in November 1995. It is a lipid-based formulation of amphotericin B amphotericin B (ăm'fətĕr`ĭsĭn), antibiotic that halts the growth of several disease-causing fungi. Discovered in 1956, it is produced by bacteria of the genus Streptomyces. . Abelcet is the market leader among the 3 commercially available lipid-based formulations of amphotericin B. ABELCET offers clinicians the efficacy of amphotericin B combined with a greatly improved safety profile. ABELCET is indicated for the treatment of invasive fungal infections in patients who are refractory to or intolerant of conventional amphotericin B therapy. The adverse events most commonly reported with ABELCET are transient chills and/or fever during infusion of the drug. ABELCET is contraindicated in patients who have shown hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen.  to amphotericin B or any other component in the formulation. Please see full prescribing information before using ABELCET or any product mentioned in this press release.

About Enzon Pharmaceuticals

Enzon Pharmaceuticals is a biopharmaceutical company dedicated to the discovery, development and commercialization of therapeutics to treat life-threatening diseases. The Company has developed or acquired a number of marketed products, including PEG-INTRON(R), marketed by Schering-Plough, and ABELCET(R), ONCASPAR(R), ADAGEN(R), and DEPOCYT(R), which are all marketed in North America by Enzon's hospital and oncology sales forces. Enzon's science-focused strategy includes an extensive drug development program that leverages the Company's macromolecular mac·ro·mol·e·cule  
n.
A very large molecule, such as a polymer or protein, consisting of many smaller structural units linked together. Also called supermolecule.
 engineering technology platforms, including PEG modification and single-chain antibody (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)) technologies. Internal research and development efforts are complemented by strategic transactions that provide access to additional products, projects, and technologies. Enzon has several drug candidates in various stages of development, independently and with partners. For further information on Enzon please refer to the Company's website at www.enzon.com.

There are forward-looking statements contained herein that are not based on historical fact, including without limitation statements containing the words "believes," "may," "plans," "will," "estimates," "continue," "anticipates," "intends," "expects," and similar expressions. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause actual results, events or developments to be materially different from the future results, events or developments discussed above. Such factors include the risk that Enzon may not be able to enroll a sufficient number of patients in the CLEAR II registry to make it a clinically valuable tool, as well as those described in Enzon's Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 and Forms 10-Q on file with the SEC. These factors should be considered carefully and readers are cautioned not to place undue reliance on such forward-looking statements. All information in this press release is as of March 24, 2004 and the Company undertakes no duty to update this information.
COPYRIGHT 2004 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2004, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

 Reader Opinion

Title:

Comment:



 

Article Details
Printer friendly Cite/link Email Feedback
Publication:Business Wire
Geographic Code:1USA
Date:Mar 24, 2004
Words:983
Previous Article:Pronexus Introduces Turnkey Speech Applications for Microsoft Speech Server 2004.
Next Article:Navigant Consulting Identifies Expansion Strategies for Pharmaceutical Companies Facing a Maturing Market.



Related Articles
Enzon Acquires Abelcet North American Business From Elan Transaction Bolsters Bottom Line and Marks a Significant Step Toward Full Integration.
Important Role of ABELCET in Antifungal Management Highlighted at Infectious Disease Conference; New studies show potential of ABELCET in new...
Enzon Reinforces Commitment to Improving Patient Outcomes in Fungal Disease by Reinitiating CLEAR Registry.
ENZON/INEX SIGN COMMERCIALIZATION PACT FOR ONCOLOGY DRUG ONCO TCS.
Enzon Reports Third Quarter Financial Results; Product Sales Increase by 28%.
Enzon and INEX Announce FDA Acceptance of Onco TCS New Drug Application.
Enzon Issues Revised Revenue Guidance for Fiscal 2005.
Enzon Revises ABELCET Guidance for Fiscal 2005.
Enzon Reports First Quarter Results.
Clinical trials: the case for registration.(EDITORIAL)(Editorial)

Terms of use | Copyright © 2009 Farlex, Inc. | Feedback | For webmasters | Submit articles