Rockwell Medical Completes Patient Enrollment in PRIME Clinical Study
Full Enrollment Met in ESA-Sparing Trial
(firmenpresse) - WIXOM, MI -- (Marketwire) -- 04/30/12 -- 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, announced today that it has completed patient enrollment in its PRIME clinical study, which is designed to investigate the reduction in the need for erythropoietin stimulating agents (ESA) in hemodialysis patients receiving Soluble Ferric Pyrophosphate (SFP) via dialysate.
Robert L. Chioini, Chairman and CEO of Rockwell, stated, "We are excited to achieve another important milestone in our SFP clinical development. The PRIME study is expected to generate compelling clinical data that we anticipate will differentiate SFP as an advanced iron-delivery therapy for hemodialysis patients, once FDA approved."
The PRIME study is a nine-month, multi-center study randomizing 100 patients equally to dialysate containing SFP-iron versus conventional dialysate. The primary objective of the study is to determine whether regular administration of SFP-iron via dialysate reduces the requirement for erythropoietin stimulating agents (ESAs) by maintaining iron balance and optimizing iron delivery. The primary end point is percent change from baseline in ESA dose required to maintain Hgb in the target range. Secondary endpoints include ESA response index (ERI), measures of oxidative stress, hemoglobin variability and amount of supplemental intravenous iron needed.
Rockwell Medical is 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. Rockwell's lead drug candidate for iron therapy treatment is called SFP. SFP delivers iron in a non-invasive, physiologic manner to dialysis patients via dialysate during their regular dialysis treatment. SFP is currently in ongoing Phase III clinical trials (CRUISE-1 and CRUISE-2) and addresses a $600M U.S. market. Rockwell's Calcitriol (Active Vitamin D) injection for treating secondary hyperparathyroidism addresses a $350M U.S. market.
Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad. These products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Rockwell's operating business is designed as a ready-made sales and distribution channel to provide seamless integration for its drug products into the commercial markets, Calcitriol and SFP upon FDA market approval.
Rockwell's exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell Medical is developing a pipeline of drug therapies, including extensions of SFP for indications outside of hemodialysis. Please visit for more information. For a demonstration of SFP's unique mechanism of action in delivering iron via dialysate, please view the animation video at .
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws. Words such as "may," "might," "will," "should," "believe," "expect," "anticipate," "estimate," "continue," "predict," "forecast," "project," "plan," "intend" or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in Rockwell Medical's SEC filings. Thus, actual results could be materially different. Rockwell Medical expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.
Contact:
Michael Rice
Investor Relations
646-597-6979
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Datum: 30.04.2012 - 05:30 Uhr
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