CAMBRIDGE, Mass., March 6 /PRNewswire-FirstCall/ -- Advanced Magnetics today announced that data from three completed Phase III multi- center clinical studies of ferumoxytol as an intravenous iron replacement therapeutic will be presented during the National Kidney Foundation (NKF) 2007 Spring Clinical Meetings taking place April 10th through 14th in Orlando, Florida. Two posters containing the data are scheduled to be presented on Wednesday, April 11, 2007 at approximately 5:30 pm ET.
One poster will include data from the company’s two completed studies in non dialysis-dependent chronic kidney disease (NDD-CKD) patients. The company plans to present additional data from its first NDD-CKD study, protocol 62,745-6, for which initial data was presented at the American Society of Nephrology Renal Week 2006 Annual Meeting in November 2006. This safety and efficacy study enrolled 304 NDD-CKD patients who were randomized to receive either two 510 mg doses of ferumoxytol within one week or 200 mg of oral iron daily for three weeks. The primary endpoint in the study was the mean change in hemoglobin from baseline in the ferumoxytol group compared to that in the oral iron treatment group. Results from the second NDD-CKD study, protocol 62,745-7, which completed enrollment in November 2006 will also be presented in this poster. This safety and efficacy study also enrolled 304 NDD-CKD patients who were randomized to receive either two 510 mg doses of ferumoxytol within one week or 200 mg of oral iron daily for three weeks. The primary endpoint in the study was also the mean change in hemoglobin from baseline in the ferumoxytol group compared to that in the oral iron treatment group.
The second poster will include data from the company’s large scale safety study in both dialysis-dependent (DD-CKD) and NDD-CKD patients, protocol 62,745-8, which completed enrollment in September 2006. This study enrolled 750 patients in a double-blind, placebo-controlled, crossover safety study comparing a single dose of 510 mg ferumoxytol to placebo.
The company plans to issue a press release summarizing the data to be presented at the NKF meetings after market close on Wednesday, April 11, 2007. The announcement will be followed by a conference call at 4:30 pm ET to discuss and answer questions regarding the data from the completed studies and the status of the ferumoxytol development program.
To listen to this conference call via audio web cast, please visit the Investors section of the Advanced Magnetics website at www.advancedmagnetics.com. The web cast will also be available as a replay starting approximately one hour after the call is finished through July 11, 2007. Alternatively, to access the call via live telephone, please dial (800) 810-0924. Internationally, the call may be accessed by dialing (913) 981- 4900.
In addition to the web cast replay, a telephone replay will be available from approximately 7:30 p.m. ET on April 11, 2007 through April 25, 2007. To access the replay, please call (888) 203-1112 and use the pass code 2603141. The replay will also be available internationally at (719) 457-0820 using the same pass code.
About Advanced Magnetics
Advanced Magnetics, Inc. is a developer of superparamagnetic iron oxide nanoparticles used in pharmaceutical products. As a leader in our field, we are dedicated to the development and commercialization of our proprietary nanoparticle technology for use in therapeutic iron compounds to treat anemia, as well as novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease. For more information about us, please visit our website at http://www.advancedmagnetics.com, the content of which is not part of this press release.
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 in this press release that do not describe historical facts, including but not limited to, statements regarding our intent to present data from completed ferumoxytol studies at the 2007 NKF Spring meetings, to issue a press release containing a summary of such data, and to conduct a conference call to discuss and answer questions regarding such data and the status of the ferumoxytol program, 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 clinical development of ferumoxytol, or may not be able to complete the development in a timely or cost-effective manner, due to the failure of our trials to demonstrate that ferumoxytol is safe and efficacious, the timing of enrollment of patients in the Phase III studies, unexpected results from our clinical sites, inadequate performance by third-party service providers involved in the conduct of the clinical trials, deficiencies in the design or oversight by us of these trials, 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) the possibility that the results of past ferumoxytol studies may not be replicated in future studies;(3) the possibility that we may not be able to obtain the necessary regulatory approvals in order to market and sell ferumoxytol, or we may not obtain such approvals in a timely manner; (4) the fact that we lack sales and marketing expertise; (5) uncertainties relating to our patents and proprietary rights; and (6) other risks identified in our Securities and Exchange Commission filings. We caution readers 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.
Contact: Lynn Kettleson Clarke Communication Group lkettleson@clarkecommgroup.com (617) 512-5922
Advanced Magnetics, Inc.
CONTACT: Lynn Kettleson of Clarke Communication Group, +1-617-512-5922, orlkettleson@clarkecommgroup.com, for Advanced Magnetics, Inc.
Web site: http://www.advancedmagnetics.com/
