WIXOM, MI -- (Marketwired) -- 07/11/13 -- Rockwell Medical (NASDAQ: RMTI)
•In dialysis patients not receiving IV iron, SFP effectively delivers iron via dialysate and maintains hemoglobin without increasing stored iron (ferritin); strong safety data demonstrates no anaphylactic or hypersensitivity events and no increase in hypotension or infection
•Conference call to be held today, Thursday July 11, 2013 at 8:00am Eastern Time
Rockwell Medical (NASDAQ: RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron deficiency, secondary hyperparathyroidism and hemodialysis, today announced successful top-line results from the long-term CRUISE-1 Phase 3 efficacy study of SFP. SFP is the Company's late-stage investigational iron-delivery drug for the treatment of iron deficiency in chronic kidney disease patients receiving hemodialysis. In the Phase 3 efficacy study, SFP met the primary endpoint, demonstrating a statistically significant mean change in hemoglobin from baseline to End-of-Treatment. Additionally, SFP met key secondary endpoints, including maintenance of hemoglobin, maintenance of reticulocyte hemoglobin, and increase in serum iron pre-to-post treatment without an increase in ferritin. This long-term study is the first of two identical Phase 3 efficacy studies to provide clinical data required for the Company to file a New Drug Application (NDA) with the U.S. FDA.
Rob Chioini, Founder, Chairman and CEO of Rockwell Medical stated, "We are thrilled with the successful results of this CRUISE-1 efficacy study. In addition to demonstrating statistical significance and meeting the primary efficacy endpoint, the data show that in place of IV iron, SFP is a safe and effective iron replacement therapy that consistently maintains hemoglobin levels without increasing iron stores. These successful results, coupled with the recent positive PRIME study data demonstrating SFP's ability to significantly reduce ESA use, support our belief that SFP will set a new paradigm in iron therapy treatment for hemodialysis patients. We believe SFP is positioned to become the new standard of care in iron therapy. We anticipate confirmatory and successful results from the CRUISE-2 trial, which is nearing completion."
Primary Efficacy Endpoint
The CRUISE-1 study successfully met its pre-defined primary efficacy endpoint, which was a change in hemoglobin from Baseline to End-of-Treatment between the SFP and placebo groups. The mean difference between SFP and placebo was 3.6 g/L (95% CI 0.8, 6.3) in favor of SFP, and was statistically significant (p=0.011).
At baseline the two groups had similar hemoglobin levels (109.6 g/L SFP and 109.0 g/L placebo). The mean adjusted change from baseline hemoglobin to the end of the randomized treatment period in the SFP group was 0.6 g/L (95% CI -1.7, 2.8). In the placebo group there was a statistically significant decline of -3.0 g/L (95% CI -5.3, -0.8).
Key Secondary Endpoints
The key secondary endpoints at End-of-Treatment showed statistically significant differences between the SFP and placebo groups, including the pre-dialysis reticulocyte hemoglobin (CHr) and serum ferritin. CHr, an early index and the best marker of iron-delivery to the bone marrow, was maintained at baseline levels in the SFP group during the randomized treatment, compared to a significant decrease in the placebo group. At End-of-Treatment, the difference between groups was a statistically significant 2.1% difference in favor of SFP (p < 0.001). Serum ferritin, a marker of tissue iron stores, declined by 14.7% from baseline in the SFP arm while the placebo group ferritin level declined by 28.2%. The difference between groups was statistically significant (p < 0.001). These results indicate that hemodialysate containing 2 µM SFP iron delivers sufficient iron to maintain erythropoiesis and does not lead to tissue iron overload.
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