Sunday, July 28, 2013

Treatment candidate helps increase, maintain CKD patients’ hemoglobin levels.

The Wall Street Journal (7/12, Chaudhuri, Subscription Publication, 2.29M) reports Rockwell Medical Inc. on Thursday announcedpositive results from the first of two Phase III clinical trials testing it investigational treatment for anemia in patients with chronic kidney disease who are undergoing hemodialysis.
        According to the AP (7/12, Seaman), the Wixom, Michigan-based biopharmaceutical company said the participants in the late-stage study who were administered its treatment candidate, soluble ferric pyrophosphate (SFP), had increased hemoglobin levels and were “also better able to maintain their hemoglobin levels.” Rockwell suggested that “small, frequent doses” of SFP, “designed to travel directly to the bone marrow” to avoid liver damage, “could be safer and more effective than the standard treatment, which involves large doses of intravenous iron.”
        Reuters (7/12, Dey, Manocha) adds that Rockwell said it expects results from the second Phase III trial testing SFP, which is nearing completion, to confirm the results released yesterday, after which the company plans to submit the combined data with a new drug application to the US Food and Drug Administration. MedPage Today (7/12, Fiore) also covers the story.

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