Healthcare Industry News: chronic kidney disease
News Release - March 19, 2007
Advanced Magnetics Completes Enrollment in Final Planned Phase III Study of Ferumoxytol as an IV Iron Replacement TherapeuticCAMBRIDGE, Mass., March 19 (HSMN NewsFeed) -- Advanced Magnetics (Nasdaq: AMAG ) today announced that it has completed enrollment in a clinical study of ferumoxytol in 230 dialysis-dependent chronic kidney disease (DD-CKD) patients. The trial is the fourth and final planned multi-center study in the company's Phase III development program for ferumoxytol, an intravenous (IV) iron replacement therapeutic for the treatment of anemia in chronic kidney disease (CKD) patients.
In this study, protocol 62,475-5, patients 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 is the mean change in hemoglobin from baseline in the ferumoxytol group compared to that in the oral iron treatment group.
With completion of enrollment in the DD-CKD trial, 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 CKD patients studied in the overall Phase III program to demonstrate ferumoxytol's safety and clinical benefit.
"Having achieved the important milestone of completing patient enrollment in our Phase III development program, we now look forward to presenting results from multiple trials in the weeks and months ahead, and remain focused on the day that ferumoxytol might become available to all chronic kidney disease patients and physicians," stated Brian J.G. Pereira, M.D., Advanced Magnetics' President and Chief Executive Officer.
Advanced Magnetics' Phase III development program for ferumoxytol is comprised of four clinical trials; three with efficacy and safety endpoints, and one with only safety endpoints.
Results from the three completed Phase III ferumoxytol trials will be presented on Wednesday, April 11 during the National Kidney Foundation (NKF) 2007 Spring Clinical Meetings in Orlando, Florida. Two posters containing the data from the following trials are scheduled to be presented on Wednesday, April 11, 2007 at approximately 5:30 pm ET:
-- Two safety and efficacy studies, protocols 62,475-6 and 62,475-7, each of which enrolled 304 non dialysis-dependent (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 of these studies is the mean change in hemoglobin from baseline in the ferumoxytol group compared to that in the oral iron treatment group.
-- A large scale safety study in both DD-CKD and NDD-CKD patients, protocol 62,745-8, which 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 meeting 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.
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 the fact that we are on track to file an NDA for ferumoxytol in the fourth quarter of 2007, 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, 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.
Source: Advanced Magnetics
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