Combidex
ferumoxtran-10
Treatment forAdvanced Magnetics' Combidex to be Reviewed by FDA Oncologic Drugs Advisory Committee
CAMBRIDGE, Mass., and PRINCETON, N.J., February 01, 2005 -- Advanced Magnetics, Inc. and Cytogen Corporation today announced that the U.S. Food and Drug Administration's (FDA) Oncologic Drugs Advisory Committee (ODAC) is scheduled to review the regulatory filing for Combidex, Advanced Magnetics' investigational molecular imaging agent, on March 3, 2005. The companies are jointly preparing for the upcoming ODAC meeting.
Combidex (ferumoxtran-10) consists of iron oxide nanoparticles for use in conjunction with magnetic resonance imaging (MRI) to aid in the differentiation of cancerous from non-cancerous lymph nodes. Clinical trials have demonstrated that MRI exams of lymph nodes using Combidex as part of staging cancer provide increased accuracy in the evaluation of lymph nodes as cancerous or non-cancerous. Combidex received an approvable letter, subject to certain conditions, from the FDA in June 2000. In September 2004, Advanced Magnetics submitted a complete response to the approvable letter, which was accepted by the FDA and assigned a user fee goal date of March 30, 2005.
Lymph nodes are frequently the site for metastases from several types of cancer. Lymph node imaging plays a role in staging patients and determining appropriate patient management. The imaging modalities currently used for imaging lymph nodes are computed tomography (CT) and MRI without contrast. CT and MRI cannot distinguish between nodes enlarged due to inflammation and enlarged cancerous nodes, nor can they identify cancerous nodes that are not enlarged. Therefore, the current practice is to assume that enlarged nodes (typically greater than ten millimeters in size) are cancerous and to perform biopsy or surgery to establish their true status. Clinical studies have demonstrated that Combidex only accumulates in macrophage cells associated with non-cancerous lymph node tissue and can therefore facilitate differentiation between cancerous nodes and other nodes. Combidex could enable doctors using MRI to have improved diagnostic confidence in differentiating between normal and cancerous lymph nodes, irrespective of node size.
About ODAC
The ODAC is a committee formed by the FDA of external experts to
provide the FDA with independent opinions and recommendations in
the evaluation of marketed and investigational drugs for use in the
treatment of cancer. The ODAC is comprised of a core of voting
members from the fields of general oncology, pediatric oncology,
hematologic oncology, immunologic oncology, biostatistics and other
related professions, as well as a consumer and patient
representative.
About Advanced Magnetics
Advanced Magnetics, Inc. is a developer of superparamagnetic iron
oxide nanoparticles used in pharmaceutical products. As a leader in
its field, Advanced Magnetics is dedicated to the development and
commercialization of its proprietary nanoparticle technology for
use in therapeutic iron compounds to treat anemia, as well as novel
imaging agents to aid in the diagnosis of cardiovascular disease
and cancer.
For more information, please visit www.advancedmagnetics.com.
About Cytogen Corporation
Founded in 1980, Cytogen Corporation of Princeton, NJ is a
product-driven biopharmaceutical company that develops and
commercializes innovative molecules that can be used to build
leading franchises across multiple markets. Cytogen's marketed
products include Quadramet (samarium Sm-153 lexidronam injection)
and Prostascint (capromab pendetide) kit for the preparation of
Indium In-111 capromab pendetide in the United States. Cytogen also
has exclusive United States marketing rights to Combidex
(ferumoxtran- 10) for all applications, and the exclusive right to
market and sell ferumoxytol (previously Code 7228) for oncology
applications in the United States. Combidex, an investigational
molecular imaging agent consisting of iron oxide nanoparticles, is
currently being developed for use in conjunction with magnetic
resonance imaging to aid in the differentiation of cancerous and
non-cancerous lymph nodes, and is under review by the U.S. Food and
Drug Administration. Cytogen's development pipeline consists of
therapeutics targeting prostate-specific membrane antigen (PSMA), a
protein highly expressed on the surface of prostate cancer cells
and the neovasculature of solid tumors.
For more information, please visit www.cytogen.com.
Related Articles:
Advanced Magnetics, Inc. Receives Approvable Letter From FDA For Combidex - March 24, 2005
Oncologic Drugs Advisory Committee Recommends Against Approval of a Broad Indication For Combidex - March 3, 2005
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