Rockwell Medical (RMTI) Announces Publication of Triferic Phase-1 Healthy Volunteer IV PK Study Data

October 4, 2016 8:04 AM EDT

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Rockwell Medical, Inc. (Nasdaq: RMTI) announced that the Triferic Phase-1 Healthy Volunteer Intravenous (IV) Pharmacokinetic Study has been published in the Journal of Clinical Pharmacology. Triferic is the Company’s new and innovative FDA approved anemia therapy indicated to replace iron-and maintain hemoglobin in chronic kidney disease patients receiving hemodialysis.

The published study examined the pharmacokinetics of Triferic administered to 49 healthy volunteers. The dose range spanned 2.5 to 10 mg of iron IV over 4 hours, and 15 and 20 mg of iron IV over 12 hours. Serum total iron, transferrin bound iron (TBI), hepcidin-25 and markers of oxidative stress and inflammation were obtained. The results demonstrate that Triferic iron is rapidly bound to transferrin and rapidly cleared from the circulation, with a half-life of between 1.2 and 2 hours. Triferic was completely bound to transferrin as there was no non-transferrin-bound iron found. Triferic did not induce oxidative stress at any dose. Triferic administered IV was well tolerated with a safety profile similar to placebo. The article and supplemental materials are available as open access at the Journal of Clinical Pharmacology website:

Pratt RD, Swinkels D, Ikizler TA and Gupta A: Pharmacokinetics of Ferric Pyrophosphate Citrate, a novel iron salt, administered intravenously to healthy volunteers: J Clinical Pharmacology DOI: 10:1002/jcph.819.

Rob Chioini, Founder, Chairman and CEO of Rockwell Medical, stated “This study publication contributes to our ongoing work to expand the use of Triferic to new indications, such as Peritoneal Dialysis (PD) and Total Parenteral Nutrition (TPN). The results also highlight that Triferic, upon administration, immediately donates iron to transferrin and is transported to the bone marrow for incorporation into hemoglobin, avoiding entrapment in the liver, iron overload and cardiovascular toxicity. This is one of the key advantages that Triferic has over the traditional IV iron products that have been used in dialysis patients.”

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