WIXOM, MI--(Marketwire - June 11, 2012) - 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 the independent Data Safety Monitoring Board (DSMB), providing safety oversight for the Company's Phase III SFP-iron replacement clinical program, met and informed the company that it has carefully reviewed the cumulative safety data from the Phase III CRUISE studies and identified no safety concerns. The DSMB also recommended the continuation of the Phase III CRUISE studies with no modifications. SFP is a key product in the company's development pipeline and is currently in Phase III clinical trials for use as an iron replacement therapeutic in ESRD patients.
Robert L. Chioini, Chairman and CEO of Rockwell, stated, "We are pleased with this positive news resulting from the DSMB's third safety review of our ongoing CRUISE studies. We thank the DSMB members for their work. Their recommendation that the studies should proceed to completion as planned affirms our confidence in SFP's potential to deliver iron to dialysis patients in a safe, reliable manner."
Rockwell is conducting two identical Phase III clinical trials for SFP, called CRUISE-1 and CRUISE-2. Each study is a prospective, randomized, placebo-controlled, multicenter study designed to demonstrate efficacy and safety with SFP-iron delivered via dialysate to adult CKD patients requiring hemodialysis. Each study will treat 300 patients, randomized equally between SFP and placebo groups with a treatment period of up to 12 months. The primary efficacy end-point for both studies is the mean change in hemoglobin from baseline.
About Rockwell Medical:
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, late-stage investigational drug for iron therapy treatment is called SFP (soluble ferric pyrophosphate). 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, and $1B global 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 into the commercial market for its drug products, 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 www.rockwellmed.com for more information. For a demonstration of SFP's unique mechanism of action in delivering iron via dialysate, please view the animation video at http://www.rockwellmed.com/collateral/documents/english-us/mode-of-action.html.
Certain statements in this press release constitute "forward-looking statements" within the meaning of the federal securities laws, including, but not limited to, Rockwell's intention to launch Calcitriol and SFP following FDA approval. 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 Rockwell Medical 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.