Advanced 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.
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.
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.
Posted: February 2005
- 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