Data from Rockwell Medical's Phase IIb study of SFP presented at ASN meeting

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 that the Company will present new data at the American Society of Nephrology (ASN) meeting being held in Denver, Colorado, on its late-stage investigational drug Soluble Ferric Pyrophosphate(SFP), which is being studied for the treatment of iron-deficiency anemia in ESRD patients.

Data from the Company's Phase IIb dose ranging clinical trial demonstrated a significant 13% dose reduction in ESA and 0.79 g/dL increase in hemoglobin compared to placebo in the intermediate therapeutic dose groups of 12 and 10 µg iron per dL respectively.  Further data revealed the placebo group did not show a significant decline in Hgb despite iron withholding, suggesting that prior IV-iron therapy had resulted in excess iron stores.

Ajay Gupta, Chief Scientific Officer of Rockwell, stated, "This study data on ESA-sparing with concomitant increase in hemoglobin provides important information about SFP and it's unique mode of action once it enters the bloodstream via the dialysate. By transferring iron rapidly and directly to apo-transferrin, SFP appears to overcome inflammatory reticuloendothelial block thereby delivering iron directly to the bone marrow for hemoglobin generation and enhancing ESA responsiveness."

Dr. Ajay Singh, Associate Professor of Medicine at Harvard Medical School, commented, "This clinical trial data may call into question the therapeutic strategy of liberalizing IV iron administration and targeting higher serum ferritin levels in an effort to reduce ESA utilization, as it may further aggravate the state of iron overload."

The study findings were presented during the poster session at the annual American Society of Nephrology (ASN) Annual Meeting entitled, "Reduced ESA Requirement by Continuous Delivery of Soluble Ferric Pyrophosphate (SFP) via Dialysate in CKD−HD Patients" and "IV Iron Therapy Leads to Iron Overload in CKD-HD Patients" on Friday, November 19, 2010; 10:00am−2:30pm.