Printer Friendly
The Free Library
19,607,053 articles and books
Member login
User name  
Password 
 
Join us Forgot password?

Enzon Files sBLA for First-Line Use of ONCASPAR(R); FDA Accepts Application for Review.


BRIDGEWATER, N.J. -- Enzon Pharmaceuticals, Inc. (Nasdaq: ENZN) announced today that 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.
) has accepted its supplemental biologics license application (sBLA) seeking approval for an expanded label for its pediatric pediatric /pe·di·at·ric/ (pe?de-at´rik) pertaining to the health of children.

pe·di·at·ric
adj.
Of or relating to pediatrics.
 oncology product, ONCASPAR, as a first-line therapy for the treatment of patients with 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). Currently, ONCASPAR is indicated for patients with ALL who require L-asparaginase in their treatment regimen, but have developed 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 the native forms of L-asparaginase. The Company anticipates that the FDA will take action on the sBLA during the third quarter of 2006.

"Today's announcement further demonstrates our renewed commitment to optimizing the potential of our marketed products and to children stricken with cancer," said Jeffrey H. Buchalter, Enzon's chairman and chief executive officer. "ONCASPAR is an important drug today in the treatment of pediatric ALL and we believe this filing supports a greater role for this therapy. We look forward to working closely with the FDA throughout this review process and making the therapeutic advantages of ONCASPAR available as a first-line treatment A first-line treatment or first-line therapy is a medical therapy recommended for the initial treatment of a disease, sign or symptom, usually on the basis of empirical evidence for its efficacy.  for ALL patients."

Enzon is supporting its application for this expanded indication based on data from two randomized ran·dom·ize  
tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es
To make random in arrangement, especially in order to control the variables in an experiment.
 studies conducted by the Children's Cancer Group (CCG CCG Chicago
CCG Collectible Card Game
CCG Canadian Coast Guard
CCG Country Commercial Guide
CCG Children's Cancer Group
CCG Commission Canadienne des Grains (Canadian Grain Commission) 
), CCG-1962 and CCG-1991, with safety data from more than 2,000 patients.

CCG-1962 is a randomized controlled study comparing ONCASPAR versus native L-asparaginase (Elspar(R)) for the first-line treatment of pediatric ALL patients. The observed advantages of ONCASPAR versus native L-asparaginase in CCG-1962 included a lower incidence of neutralizing antibodies, more rapid clearance of lymphoblasts from the bone marrow, and a more convenient dosing schedule. Enzon is using the data from CCG-1962 to support its sBLA for ONCASPAR with efficacy data from 118 patients. The CCG-1962 study was published in the March 2002 issue of Blood, a publication of the American Society of Hematology.

The observed advantages of ONCASPAR in the CCG-1962 study led to the use of ONCASPAR in a subsequent study, CCG-1991. CCG-1991 is a multi-arm study using ONCASPAR in the first-line setting. Enzon is using the interim results from CCG-1991 to support its sBLA for ONCASPAR with safety data from over 2,000 patients. A detailed analysis of the CCG-1991 study is being reviewed for publication in a major medical journal.

An estimated 35,000 new cases of leukemia will have been diagnosed 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.  during 2005. Of these about 4,000 will have been acute lymphoblastic leukemia (also called acute lymphocytic leukemia acute lymphocytic leukemia
n.
See acute lymphoblastic leukemia.


acute lymphocytic leukemia Acute lymphoblastic leukemia, ALL A malignant lymphoproliferative process that commonly affects children and young adults
 or ALL). Although ALL is mainly a childhood leukemia, about one-third of new cases will occur in adults.

About ONCASPAR

ONCASPAR is a PEG-enhanced version of the naturally occurring enzyme L-asparaginase. L-asparaginase is an enzyme that depletes the amino acid amino acid (əmē`nō), any one of a class of simple organic compounds containing carbon, hydrogen, oxygen, nitrogen, and in certain cases sulfur. These compounds are the building blocks of proteins.  asparagine asparagine (əspâr`əjēn), organic compound, one of the 20 amino acids commonly found in animal proteins. Only the l-stereoisomer participates in the biosynthesis of mammalian proteins. , which certain leukemic cells are dependent upon for survival. ONCASPAR was granted a marketing license by the U.S. Food and Drug Administration in February 1994 to treat patients with acute lymphoblastic leukemia who require L-asparaginase in their treatment regimen, but have developed hypersensitivity to native forms of L-asparaginase. Through its proprietary PEGylation technology, Enzon designed ONCASPAR to offer therapeutic advantages over unmodified L-asparaginase. In addition to reduced immunogenicity immunogenicity /im·mu·no·ge·nic·i·ty/ (-je-nis´it-e) the property enabling a substance to provoke an immune response, or the degree to which a substance possesses this property. , ONCASPAR provides a more convenient, patient-friendly dosing regimen that allows for administration every 14 days, versus twice weekly for unmodified L-asparaginase. Enzon's specialized oncology sales force markets ONCASPAR in North America North America, third largest continent (1990 est. pop. 365,000,000), c.9,400,000 sq mi (24,346,000 sq km), the northern of the two continents of the Western Hemisphere. .

About Enzon

Enzon Pharmaceuticals, Inc. is a biopharmaceutical company dedicated to the development and commercialization of therapeutics to treat patients with cancer and other life-threatening diseases. Enzon's specialized sales force markets ABELCET(R), ONCASPAR(R), ADAGEN(R), and DEPOCYT(R) in North America. In addition, Enzon also receives royalties on sales of PEG-INTRON(R), marketed by Schering-Plough Corporation, and MACUGEN(R), marketed by OSI Pharmaceuticals OSI Pharmaceuticals, Inc. is an American pharmaceutical company based in Long Island, New York with facilities in Colorado, New Jersey and the United Kingdom. They specialize in the discovery and development of molecular targeted therapies, and are listed in the NASDAQ  and Pfizer Inc. Enzon's product-driven strategy includes an extensive drug development program that leverages its proprietary technologies, including a next-generation PEGylation platform that utilizes linkers designed to release compounds at a controlled rate. Enzon complements its internal research and development efforts with strategic initiatives, such as partnerships designed to broaden its revenue base or provide access to promising new technologies or product development opportunities. Further information about Enzon and this press release can be found on the Company's web site 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," "estimate," "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. Among the factors that could cause actual result, events or developments to differ materially are decisions by regulatory authorities regarding whether and when to approve our drug applications as well as their decisions regarding labeling and other matters that could affect the commercial potential of the Company's products. All information in this press release is as of December 1, 2005 and the Company undertakes no duty to update this information.
COPYRIGHT 2005 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2005, 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:Dec 1, 2005
Words:835
Previous Article:Welding Industry Wins Madison County Welding Fume Trial; Jury Verdict Marks Another Significant Industry Victory.
Next Article:Offshore Logistics, Inc. Announces New Financial Team.
Topics:



Related Articles
Enzon Institutes Labeling and Distribution Modifications For ONCASPAR.
U.S. Application Submitted for PEG-INTRON and REBETOL for Use as Combination Therapy for Chronic Hepatitis C.
Enzon Announces FDA Assigns Priority Review Status to PEG-INTRON and REBETOL Application for Chronic Hepatitis C.
Enzon Announces Interim Results Of PEG-INTRON Plus REBETOL Studies in Hepatitis C Patients Reported At Digestive Diseases Week Meeting.
ENZON/INEX SIGN COMMERCIALIZATION PACT FOR ONCOLOGY DRUG ONCO TCS.
Enzon Reports First Quarter Results; Product Sales Increase 10% Over Prior Year and Comprise Nearly 70% of Revenues.
Enzon Initiates Clinical Program for ONCASPAR(R); FDA Completes Review of IND.
FDA Approves Enzon's Oncaspar(R) for First-Line Use in Acute Lymphoblastic Leukemia.
Enzon Pharmaceuticals Announces Advancements in Its Oncology Pipeline; Oncaspar Phase I solid tumor trial begins; IND approved for rhMBL study.
Enzon Reports First Quarter 2007 Results.

Terms of use | Copyright © 2012 Farlex, Inc. | Feedback | For webmasters | Submit articles