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- Study Met All Primary and Secondary Endpoints -
Advanced Magnetics (NASDAQ: AMAG) today announced preliminary positive results from its fourth and final planned Phase III clinical trial of ferumoxytol as an intravenous (IV) iron replacement therapeutic in chronic kidney disease (CKD) patients. The open-label, multi-center, randomized study in CKD patients on hemodialysis demonstrated a statistically significant achievement of all the primary and secondary endpoints. The results from this trial are consistent with the previously reported data from the three other Phase III studies conducted by Advanced Magnetics in CKD patients to date.
The study being reported on today (ClinicalTrials.gov NCT00233597) enrolled 230 hemodialysis dependent CKD patients who were receiving stable doses of erythropoietin therapy. Patients were randomized 1:1 to receive either two 510 mg doses of IV ferumoxytol within one week or 200 mg of oral iron daily for three weeks. The primary endpoint was the mean change in hemoglobin from baseline at Day 35 after the first dose. The secondary endpoints included the proportion of patients with at least a 1.0 g/dL rise in hemoglobin at Day 35, and the mean change in serum ferritin from baseline to Day 21.
"We are very pleased with the results that we are releasing today from our fourth and final ferumoxytol Phase III study in CKD patients. We now have released data from all of our planned pivotal studies of ferumoxytol in CKD patients. The consistent, statistically significant achievement of all primary and secondary endpoints across all trials and at all stages of CKD is important," stated Brian J.G. Pereira, MD, President and CEO of Advanced Magnetics. "Now that the execution phase of our pivotal program in CKD patients is complete, we are focused on the preparation of the ferumoxytol New Drug Application (NDA) filing, which is on track for the fourth calendar quarter of 2007."
"This was a well designed and well executed program which I believe has consistently demonstrated the efficacy and tolerability of ferumoxytol relative to oral iron and placebo in CKD patients," stated Dr. Allen Nissenson, MD, Professor of Medicine and Director of the Dialysis Program at David Geffen School of Medicine at UCLA and Chair of the Ferumoxytol Scientific Advisory Board. "In my opinion, results across the pivotal program are impressive and suggest ferumoxytol may provide a useful, more convenient therapy in treating anemia in patients with CKD."
Efficacy results for the intent to treat (ITT) population and the efficacy evaluable populations were similar to and consistent with the previous studies in CKD patients. The study enrolled iron deficient anemic hemodialysis patients with a mean ± standard deviation hemoglobin of 10.59 ± 0.67 g/dL in the ferumoxytol group and 10.69 ± 0.57 g/dL in the oral iron group. ITT results from all patients randomized to either ferumoxytol or oral iron showed:
* For the primary endpoint, which was change in hemoglobin from baseline to Day 35 after the first dose, patients receiving ferumoxytol achieved a significantly greater mean increase in hemoglobin compared to patients receiving oral iron (ferumoxytol 1.02 ± 1.13 g/dL vs. oral iron 0.46 ± 1.06 g/dL, p=0.0002).
* For one secondary endpoint, a higher proportion of ferumoxytol-treated patients achieved at least a 1.0 g/dL rise in hemoglobin at Day 35 compared to patients taking oral iron (49.1% of ferumoxytol patients vs. 25.0% of oral iron patients, p=0.0002).
* For the other secondary endpoint, the mean increase in serum ferritin from baseline was significantly greater in the ferumoxytol group compared to the oral iron group at Day 21 (ferumoxytol 356.7 ± 247.1 ng/mL vs. oral iron -37.6 ± 107.0 ng/mL, p<0.0001).
The safety results in 223 hemodialysis patients exposed to either ferumoxytol or oral iron in this study were consistent with previous studies and showed:
* There were no events of anaphylaxis or anaphylactoid events in either group.
* Adverse events (AEs) occurred in 49.1% of patients after ferumoxytol administration and in 56.6% of patients after oral iron administration.
* Drug-related AEs occurred in 8.2% of patients after ferumoxytol administration and in 15.9% of patients after oral iron administration.
* One drug-related serious adverse event (SAE) occurred in a patient after ferumoxytol administration (0.9%). The patient experienced transient hypotension and recovered without sequelae. There were no drug-related SAEs in the oral iron-treated patients in this study.
* There were no clinically significant mean changes in vital signs, physical exam findings or laboratory values from baseline for patients after either ferumoxytol or oral iron administration.
Across all phases of the ferumoxytol clinical program with approximately 2,800 total administered doses of ferumoxytol, there were no cases of anaphylaxis and no drug-related deaths. Drug-related SAEs were as follows:
* Three of 1,722 ferumoxytol-treated patients (0.17%) experienced a drug related SAE;
-- One patient experienced an anaphylactoid event with
hypotension, as previously reported.
-- One patient developed transient hypotension as described above.
-- One patient from the study announced today who was previously
assigned to oral iron in the randomized phase of the study
experienced a drug-related SAE of transient hypotension in the
readmission arm after ferumoxytol treatment. Similar to the
other Phase III efficacy studies, this readmission arm was a
non-randomized open-label elective retreatment arm that allowed
patients who continued to meet entry criteria to receive a
course of ferumoxytol (2 x 510 mg), irrespective of original
* One of 289 patients (0.35%) treated with oral iron experienced a drug-related SAE of severe gastritis, as previously reported.
* One of 781 patients (0.13%) treated with IV saline (placebo) experienced a drug-related SAE of petechiae, as previously reported.
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 patients. The Company has released data on all four planned Phase III clinical trials of feru,oxytol as an intravenous iron replacement therapeutic in chronic kidney disease patients. The Company plans to file an NDA for marketing approval of ferumoxytol with the U.S. Food and Drug Administration during the fourth calendar quarter of calendar 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, as well as novel imaging agents to aid in the diagnosis of cancer and cardiovascular disease.
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.®and GastroMARK®, both of which are imaging agents that are approved and marketed in the United States, Europe and other countries.
For more information about Advanced Magnetics, please visit the Company's 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 herein that do not describe historical facts, including but not limited to, statements regarding our plan to file an NDA for marketing approval of ferumoxytol with the U.S. Food and Drug Administration during the fourth quarter of calendar 2007, that we are on track to make such filing, and that ferumoxytol may provide a useful, more convenient therapy in treating anemia in patients with CKD, 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, 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 fact that we have limited sales and marketing experience; (4) uncertainties surrounding the reimbursement for our products and product candidates by governmental and private third party payors; (5) uncertainties relating to our patents and proprietary rights; and (6) 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.
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