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WIXOM, Mich., Oct. 20, 2010 (GLOBE NEWSWIRE) -- Rockwell Medical (Nasdaq:RMTI), a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron-deficiency anemia, announced today the design of its Phase III development program for Soluble Ferric Pyrophosphate (SFP) as a continuous iron replacement therapeutic.
With guidance given from the U.S. Food and Drug Administration (FDA), Rockwell Medical has established that the primary efficacy analysis for the two Phase III efficacy studies will be the comparison of the mean change in hemoglobin from baseline between the SFP group and the placebo group. Branded as the CRUISE (
Equivalents) study, each of the Phase III efficacy studies will have two treatment groups: one receiving an 11 mcg/dL dose of SFP-iron (via dialysate) every dialysis treatment and one receiving conventional dialysate without iron every dialysis treatment. Each study will treat 300 patients, with a one-to-one randomization between SFP and placebo. Study treatment duration will be up to 12 months.
"We are pleased that our positive dialogue with the FDA led to what we believe to be a robust Phase III program," stated Robert L. Chioini, Chairman, CEO and President of Rockwell. "We are very encouraged that the FDA supports our Phase III primary efficacy endpoint, which demonstrated statistical significance in our Phase IIb study. We have submitted our Phase III protocol in its entirety to the Agency and we have made significant progress in site recruitment. As a result, we anticipate commencing the Phase III program within the next 90 days."
SFP is a novel, investigational, continuous iron therapy in late-stage clinical development, designed to treat iron deficiency-anemia in ESRD patients. In contrast to intravenous (IV) iron delivery, SFP is a proprietary, water-soluble iron that travels to the bloodstream and binds directly to apo-transferrin and then travels to bone marrow to assist in forming a healthy red blood cell, similar to normal physiologic dietary iron intake. SFP is a continuous iron replacement treatment, delivering small doses of iron during every dialysis session, to replenish the 5-7mg of iron lost during the dialysis procedure, thereby maintaining hemoglobin in the target range as per Kidney Disease Quality Outcomes Initiative (KDQOI) recommendations. Clinical trial data to date suggests that SFP, delivered via dialysate during each dialysis treatment, maintains optimal iron balance and avoids liver toxicity while decreasing associated drug administration costs. Academic studies have shown that more frequent maintenance doses of iron improve therapeutic response to erythropoiesis-stimulating agents (ESA's), thereby decreasing the ESA doses needed to maintain hemoglobin in the target range. Rockwell has licensed exclusive world-wide rights to manufacture and sell SFP and has obtained patent protection for SFP in multiple countries, including the three largest dialysis markets in the world: the United States, Japan, and the European Union. Based on current market data, the U.S. dialysis market for IV iron is approximately $560 million annually while global market potential is approximately $1 billion.