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Rockwell Medical Announces Clean Safety Results From Triferic(TM) Short-Term Safety Study


October 21, 2013 - Wixom, MI

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, today announced positive safety results of its large Phase 3 short-term safety study that was conducted in support of the New Drug Application for marketing approval of Triferic™. Triferic™ is the Company's late-stage investigational iron-replacement drug for the treatment of iron deficiency in chronic kidney disease patients receiving hemodialysis.

"We are very pleased with the results of the short-term safety study," stated Mr. Rob Chioini, Founder, Chairman and CEO of Rockwell. "Triferic's™ clean safety profile together with its unique mode of action enabling efficient iron delivery and hemoglobin maintenance, while significantly reducing the need for ESA, highlight its potential to be the market-leading iron therapy treatment for CKD-HD patients."

"We continue to be impressed with Triferic™ and its safety profile," stated Dr. Ray Pratt, CMO of Rockwell. "Our clinical program is easily the largest and longest cohort of any parenteral iron drug and after 100,000 accumulated administrations we have not seen a single acute safety signal or anaphylactic reaction. This additional safety data, coupled with the successful Phase 3 CRUISE studies and ongoing open-label study, gives us great confidence that Triferic™ can provide dialysis patients safe, effective iron therapy."

This safety study was a prospective, randomized, double-blinded, placebo-controlled, crossover, multicenter, multinational, Phase 3 study with an enrollment of 718 CKD-HD patients in the US and Canada. It is followed by an ongoing optional open-label, uncontrolled extension study. Consistent with expectations, this study demonstrated that:

  • Triferic™ reliably delivers iron via dialysate.
  • There were no specific adverse events directly attributable to Triferic™.
  • The adverse events during Triferic™ administration were those common in CKD-HD patients.
  • No difference in type, frequency, severity or resolution of adverse events between Triferic™ and placebo.
  • No anaphylaxis or hypersensitivity attributable to Triferic™.
  • No evidence of changes in hepatic enzymes between Triferic™ and placebo.
  • No evidence of first use events or an increase in hypotension.

In conclusion, the safety profile of Triferic™ is no different from placebo in this large, short-term safety study. Triferic™ shows no acute safety signals when administered via dialysate. The results of this study will be presented at the upcoming American Society of Nephrology meeting in Atlanta, GA November 6-10 2013.

About Triferic
Triferic™ is a unique iron compound that is delivered to the hemodialysis patient via dialysate, replacing the 5-7 mg of iron that is lost during every dialysis treatment. Triferic™ is introduced into the sodium bicarbonate concentrate on-site at the dialysis clinic, which is subsequently mixed into dialysate. Once in the dialysate, Triferic™ crosses the dialyzer membrane and enters the blood where it immediately binds to apo-transferrin and is taken to the bone marrow, similar to how dietary iron is processed in the human body. In completed clinical trials to date, Triferic™ has demonstrated that it can safely and effectively deliver sufficient iron to the bone marrow, maintain hemoglobin and not increase iron stores (ferritin), while significantly reducing ESA dose.

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 lead drug candidate Triferic™ is in late-stage clinical development for the treatment of iron replacement in dialysis patients. Triferic™ delivers iron to the bone marrow of dialysis patients in a non-invasive, physiologic manner during their regular dialysis treatment, using dialysate as the delivery mechanism. In completed clinical trials to date, Triferic™ has demonstrated that it can safely and effectively deliver sufficient iron to the bone marrow, maintain hemoglobin and not increase iron stores (ferritin), while significantly reducing ESA dose. Triferic™ has completed the efficacy trials of its Phase 3 clinical study program (CRUISE-1 and CRUISE-2). Triferic™ is expected to address an estimated $600M U.S. market.

Rockwell is preparing to launch its FDA approved generic drug Calcitriol, to treat 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 launch Calcitriol once it receives FDA manufacturing approval, addressing an estimated $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. 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. and its operating infrastructure is a ready-made sales and distribution channel that is able to provide seamless integration into the commercial market for its drug products, Calcitriol and Triferic™ 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 Triferic™ for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information. For a demonstration of the Triferic™ 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 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.

Michael Rice
Investor Relations
646-597-6979

MarketWire

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