Rockwell Medical Announces Triferic Human Intravenous (IV) Pharmacokinetic Study Published in Journal of Clinical Pharmacolog...
October 04 2016 - 8:00AM
Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated
biopharmaceutical company targeting end-stage renal disease (ESRD)
and chronic kidney disease (CKD) with innovative products for the
treatment of iron replacement, secondary hyperparathyroidism and
hemodialysis, announced today that the Triferic Phase-1 Healthy
Volunteer Intravenous (IV) Pharmacokinetic Study has been published
in the Journal of Clinical Pharmacology. Triferic is the Company’s
new and innovative FDA approved anemia therapy indicated to replace
iron-and maintain hemoglobin in chronic kidney disease patients
receiving hemodialysis.
The published study examined the
pharmacokinetics of Triferic administered to 49 healthy volunteers.
The dose range spanned 2.5 to 10 mg of iron IV over 4 hours, and 15
and 20 mg of iron IV over 12 hours. Serum total iron,
transferrin bound iron (TBI), hepcidin-25 and markers of oxidative
stress and inflammation were obtained. The results demonstrate that
Triferic iron is rapidly bound to transferrin and rapidly cleared
from the circulation, with a half-life of between 1.2 and 2 hours.
Triferic was completely bound to transferrin as there was no
non-transferrin-bound iron found. Triferic did not induce oxidative
stress at any dose. Triferic administered IV was well tolerated
with a safety profile similar to placebo. The article and
supplemental materials are available as open access at the Journal
of Clinical Pharmacology website:
Pratt RD, Swinkels D, Ikizler TA and Gupta
A: Pharmacokinetics of Ferric Pyrophosphate Citrate, a novel
iron salt, administered intravenously to healthy volunteers:
J Clinical Pharmacology DOI:
10:1002/jcph.819.http://onlinelibrary.wiley.com/doi/10.1002/jcph.819/full
Rob Chioini, Founder, Chairman and CEO of
Rockwell Medical, stated “This study publication contributes to our
ongoing work to expand the use of Triferic to new indications, such
as Peritoneal Dialysis (PD) and Total Parenteral Nutrition (TPN).
The results also highlight that Triferic, upon administration,
immediately donates iron to transferrin and is transported to the
bone marrow for incorporation into hemoglobin, avoiding entrapment
in the liver, iron overload and cardiovascular toxicity. This is
one of the key advantages that Triferic has over the traditional IV
iron products that have been used in dialysis patients.”
About TrifericTriferic 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 for more information.
About Rockwell MedicalRockwell
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 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 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.
Michael Rice, Investor Relations; 646-597-6979
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