WIXOM, Mich., July 13, 2015 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (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 replacement, secondary hyperparathyroidism and hemodialysis, announced today the publication of the PRIME study results in Kidney International. Triferic is the only iron product FDA approved for delivery via dialysate to replace iron and maintain hemoglobin in hemodialysis patients in the United States.
Dr. Ajay Gupta, lead author and Chief Scientific Officer of Rockwell Medical stated, "We are very pleased with the publication of this important study in Kidney International. The study data demonstrate that Triferic is the perfect iron agent to address the unmet need of treating functional iron deficiency. Its ability to improve ESA responsiveness and reduce ESA requirements highlights its role as the ideal vehicle to deliver iron and maintain hemoglobin, while not increasing ferritin, in the HD population. Importantly, the safety and pharmaco-economic benefits of ESA reduction are realized without the occurrence of oxidative stress or iron sequestration/overload. The PRIME study data provide clear practical guidance for integrating Triferic into the management of anemia in chronic hemodialysis patients."
"We are extremely pleased to see the PRIME study results published in a premier peer-reviewed nephrology journal," stated Robert L. Chioini, Founder, Chairman and Chief Executive Officer of Rockwell Medical. "The study data showing Triferic's ability to reduce ESA use in treating anemia in hemodialysis patients should translate into significant cost savings in dialysis care, while also potentially lowering patient safety concerns associated with the current iron replacement products. Triferic's benefits, coupled with the high interest level for the drug from dialysis providers, strengthens our belief that Triferic will become the standard of care for iron maintenance therapy treatment in CKD-HD patients."
The PRIME study was a nine-month, prospective, randomized, placebo-controlled, double-blinded, multi-center study conducted in the United States to determine the safety and efficacy of Triferic (ferric pyrophosphate citrate) as a treatment to reduce ESA while maintaining hemoglobin. Iron-replete chronic hemodialysis patients were randomized to dialysate containing Triferic-iron versus conventional dialysate. A total of 103 patients received blinded study drug (52 Triferic, 51 Placebo).
The primary objective of the PRIME study was to determine whether regular administration of Triferic via dialysate reduced the need for erythropoiesis stimulating agents (ESA) by optimizing iron delivery and maintaining iron balance. The primary endpoint was the percent change in ESA dose from baseline to end of treatment (final two weeks of treatment period). After adjusting for differences in baseline hemoglobin, the Triferic arm required 35% less ESA dose compared to placebo. The difference between the two groups was statistically significant (p=0.045). The ESA sparing effect from Triferic was observed without an increase in serum ferritin or transferrin saturation above the baseline values. In a pre-specified secondary analysis of the 20% of patients who were hyporesponsive to ESA (>13,000 epoetin units/week), the Triferic group used 74.4% (p=NS) less ESA than placebo, further confirming the effect on ESA observed in the entire study cohort.
The PRIME article, Ferric pyrophosphate citrate administered via dialysate reduces erythropoiesis-stimulating agent use and maintains hemoglobin in hemodialysis patients, can be accessed in the Advanced On-line Publication section of the Kidney International Website http://www.nature.com/ki/journal/vaop/ncurrent/full/ki2015203a.html
Triferic is a unique iron compound that is delivered to hemodialysis patients via dialysate, replacing the ongoing iron loss that occurs during their dialysis treatment. Triferic is introduced into bicarbonate concentrate, on-site at the dialysis clinic, and subsequently mixed into dialysate. Once in dialysate, Triferic crosses the dialyzer membrane and enters the blood where it immediately binds to transferrin and is transported to the erythroid precursor cells to be incorporated into hemoglobin. In completed clinical trials, Triferic has demonstrated that it can effectively deliver sufficient iron to the bone marrow and maintain hemoglobin, without increasing iron stores (ferritin). Please visit www.triferic.com for more information.
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 replacement, secondary hyperparathyroidism and hemodialysis.
Rockwell's recent FDA approved drug Triferic is indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. Triferic delivers iron to patients during their regular dialysis treatment, using dialysate as the delivery mechanism. In completed clinical trials, Triferic has demonstrated that it safely and effectively delivers sufficient iron to the bone marrow and maintains hemoglobin, without increasing iron stores (ferritin). Rockwell intends to market Triferic to hemodialysis patients in the U.S. dialysis market.
Rockwell's FDA approved generic drug Calcitriol is for treating secondary hyperparathyroidism in dialysis patients. Calcitriol (active vitamin D) injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy. Rockwell intends to market Calcitriol to hemodialysis patients in the U.S. dialysis 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. As one of the two major suppliers in the U.S., Rockwell's products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient's bloodstream. Rockwell has three manufacturing/distribution facilities located in the U.S.
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 Triferic for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information.
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 Triferic 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.
Triferic™ is a trademark of Rockwell Medical, Inc.
Michael Rice, Investor Relations; 646-597-6979