Full Press Release Details
WIXOM, Mich., March 19, 2012 (GLOBE NEWSWIRE) -- 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 and secondary hyperparathyroidism, today announced that the independent Data Safety Monitoring Board (DSMB) providing oversight for the Company's Phase III SFP iron replacement therapy 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, a key product in the company's development pipeline, is in Phase III multi-center clinical trials for use as an iron replacement therapeutic in ESRD patients.
Separately, an interim analysis of the blinded and pooled data of the two SFP Phase III studies (CRUISE 1 and 2) revealed that the standard deviation of the hemoglobin change from baseline is less than 1 g/dL. In each of the two CRUISE studies the calculated sample size of 133 patients in each treatment group was based on a projected standard deviation of 1.25 g/dL. Because the actual standard deviation is less than projected, there is no need for an increase in sample size.
Mr. Robert L. Chioini, Chairman and CEO stated, "We are pleased to receive this positive news from the DSMB and thank the members for their effort. With this positive DSMB news, along with recent verification that the planned sample size for the study is sufficient, we are confident that we are in good position to complete a successful Phase III program. By delivering SFP iron via dialysate, we expect this novel iron replacement therapy will benefit all ESRD patients suffering from iron deficiency."
About Rockwell Medical:
Rockwell Medical is a fully-integrated biopharmaceutical company offering innovative products and services targeting end-stage renal disease (ESRD), chronic kidney disease (CKD), and iron deficiency anemia. The Company is currently developing unique, proprietary renal drugs to treat anemia and secondary hyperparathyroidism. 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 is expected to be available commercially later in 2012, addressing 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 in 2012 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.
The Rockwell Medical Technologies, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=6773
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.