Advanced Magnetics, Inc. Provides Update on Timing of Final Ferumoxytol Phase III Results
Published: Jun 27, 2007
CAMBRIDGE, Mass., June 27 /PRNewswire-FirstCall/ -- Advanced Magnetics, Inc. today announced that it will announce top line results from its final Phase III trial for ferumoxytol as an intravenous (IV) iron replacement therapeutic in the summer of 2007. This study is the fourth and final planned multi-center study in the company's Phase III development program for ferumoxytol in chronic kidney disease patients. The final study, in which enrollment was completed in March 2007, is a 230 patient mutli-center efficacy and safety study in hemodialysis-dependent CKD patients comparing two doses of 510 mg ferumoxytol to daily oral iron. The primary endpoint of the study is the mean change in hemoglobin from baseline on the 35th day following initial treatment in the ferumoxytol group compared to that in the oral iron treatment group. The secondary endpoints for the study include the proportion of subjects experiencing a greater than or equal to one gram per deciliter increase in hemoglobin on the 35th day following initial treatment and the mean change in serum ferritin from baseline on the 21st day following initial treatment, in each case in the ferumoxytol group compared to the oral iron group.
The company remains on schedule to file a New Drug Application (NDA) with the U.S. Food and Drug Administration for the marketing approval of ferumoxytol in the fourth calendar quarter of 2007. The company plans to submit data from over 1,600 chronic kidney disease patients studied in the overall Phase III program.
Brian J.G. Pereira, MD, President and CEO of Advanced Magnetics, will be providing an overview of the company at the Jefferies & Company Health Care Conference being held June 27, 2007 in New York at 12:30 pm ET.
A live audio webcast of this presentation will be accessible through the Investors section of the company's website at www.advancedmagnetics.com. Following the conference, the audio webcast will be archived on the Advanced Magnetics website until September 21, 2007.
About Advanced Magnetics
Advanced Magnetics, Inc. is a biopharmaceutical company that utilizes its proprietary nanoparticle technology for the development and commercialization of therapeutic iron compounds to treat anemia and novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease.
Ferumoxytol, the company's key product candidate, is being developed for use as an intravenous iron replacement therapeutic for the treatment of iron deficiency anemia in chronic kidney disease. The company has completed enrollment in four Phase III clinical trials with ferumoxytol and has presented data on three of the four trials.
Combidex, the company's other product under development, is an investigational functional molecular imaging agent consisting of iron oxide nanoparticles for use in conjunction with magnetic resonance imaging (MRI) to aid in the differentiation of cancerous from normal lymph nodes. In March 2005, the company received an approvable letter from the FDA with respect to Combidex, subject to certain conditions.
The company has two commercial products, Feridex I.V.(R) and GastroMARK(R), both of which are imaging agents that are approved and marketed in the United States, Europe and other countries.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and federal securities laws. Any statements contained herein that do not describe historical facts, including but not limited to, statements regarding our intent to publicly announce additional top line Phase III data for ferumoxytol by the end of the summer 2007, statements regarding our plans to submit data from over 1,600 chronic kidney disease patients to the FDA as part of our NDA, and statements regarding our plan to file an NDA for ferumoxytol with the FDA during the fourth quarter of 2007 are forward-looking statements that involve risks and uncertainties that could cause actual results to differ materially from those discussed in such forward-looking statements. Such risks and uncertainties include the following: (1) the possibility that we may not be able to successfully complete the development of ferumoxytol, or may not be able to complete the development in a timely or cost-effective manner, due to deficiencies in the design or oversight by us of these trials, the failure of our trials to demonstrate that ferumoxytol is safe and efficacious, unexpected results from our clinical sites, inadequate performance by third-party service providers, or any other factor causing an increase in expenses, a delay and/or a negative effect on the results of the clinical studies for ferumoxytol; (2) uncertainties surrounding our ability to obtain regulatory approval for ferumoxytol from the FDA; (3) the possibility that the results of past ferumoxytol studies may not be replicated in future studies; (4) the fact that we have limited sales and marketing experience; (5) the possibility that we may not be able to timely or cost-effectively resolve the questions raised by the FDA and satisfy the conditions specified for approval of Combidex; (6) uncertainties surrounding the reimbursement for our products and product candidates by governmental and private third party payors; (7) uncertainties relating to our patents and proprietary rights; and (8) other risks identified in our Securities and Exchange Commission filings. We caution you not to place undue reliance on any forward-looking statements which speak only as of the date they are made. We disclaim any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements.Advanced Magnetics, Inc.
CONTACT: Kristen Galfetti, Senior Director, Investor Relations of AdvancedMagnetics, Inc., +1-617-498-3362, email@example.com,
Web site: http://www.advancedmagnetics.com//