Oral and poster presentation of data for Triferic in pediatric patients and patients on intraperitoneal dialysis
Conference being held March 3-6, 2018, in Orlando, Fla.
WIXOM, Mich., Feb. 28, 2018 (GLOBE NEWSWIRE) -- Rockwell Medical, Inc. (NASDAQ:RMTI), announced today that two Triferic abstracts have been selected for presentation at the Annual Dialysis Conference March 3-6, 2018, in Orlando, Fla. Triferic is the Company’s novel iron replacement drug for the treatment of iron deficiency in chronic kidney disease patients receiving hemodialysis (HD). Triferic is the only FDA approved therapy indicated to replace iron and maintain hemoglobin in hemodialysis patients
Presentation schedule at the ADC annual meeting:
Poster Presentation:
Single Ascending Dose Study of Intraperitoneal Ferric Pyrophosphate Citrate (Triferic) in Patients on Chronic Peritoneal Dialysis
Raymond Pratt, M.D. and Ajay Gupta, MBBS, M.D.
March 4 and 5: 1 – 2 p.m. EST
Oral Presentation:
The Pharmacokinetics of Ferric Pyrophosphate Citrate (Triferic) in Pediatric CKD-5HD patients: Implications for Dosing
Raymond Pratt, M.D. and Ajay Gupta, M.D.
March 5: Pediatric Symposium Session IV: 2 p.m. EST
Raymond D. Pratt, M.D., FACP, chief medical officer of Rockwell Medical said, “These two studies continue to demonstrate the utility of Triferic as an iron replacement product to maintain hemoglobin. The pediatric study represents the completion of the first post-marketing commitment from the approval of Triferic by the U.S. FDA. Rockwell is planning to initiate a clinical study in pediatric HD patients in mid-2018 as the second part of the post-marketing commitment. The peritoneal dialysis (PD) study is the first demonstration of the ability to administer iron to PD patients.”
About Triferic
Triferic is the only FDA approved drug indicated to replace iron and maintain hemoglobin in hemodialysis patients suffering from anemia. Via dialysate during each dialysis treatment, Triferic replaces the 5-7 mg iron loss that occurs in all patients, effectively maintaining their iron balance. Unlike IV iron products, Triferic binds iron immediately and completely to transferrin (carrier of iron in the body) upon entering the blood and it is then transported directly to the bone marrow to be incorporated into hemoglobin, with no increase in ferritin (stored iron and inflammation) and no anaphylaxis, addressing a significant unmet need in overcoming Functional Iron Deficiency (FID) in ESRD patients. Please visit www.triferic.com to view the Triferic mode-of-action (MOA) video and 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. 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 and globally.
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 U.S. manufacturing/distribution facilities.
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 sell and market Calcitriol and Triferic. 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 registered trademark of Rockwell Medical, Inc.
Investor Contact:
Michael Rice
LifeSci Advisors
(646) 597-6979
mrice@lifesciadvisors.com
Media Contact:
Matt Middleman
LifeSci Public Relations
(646) 627-8384
matt@lifescipublicrelations.com