Full Press Release Details
CorMedix Inc. Provides Comprehensive Pipeline Update
During Research and Development Day
Live Webcast Today, July 12, 2017, beginning at 8:30am
Bedminster, NJ July 12, 2017 CorMedix Inc.
(NYSE MKT: CRMD), a biopharmaceutical company focused on developing
and commercializing therapeutic products for the prevention and
treatment of infectious and inflammatory disease, today provided a
comprehensive overview and update on its ongoing pre-clinical and
clinical development programs, based on its taurolidine technology
platform. The R&D Day event will be webcast live
and archived on CorMedix's website. To access the
webcast, visit the Events page at www.cormedix.com/media-publications/events/.
speakers include Prabir Roy-Chaudhury, MD, Ph.D., Co-Principal
Investigator of the Neutrolin Phase 3 LOCK-IT
100 clinical trial, Director of the Division of Nephrology and the
Arizona Kidney and Vascular Center at University of Arizona, and
Co-chair of the American Society for Nephrology's Kidney
Health Initiative; Allison O'Neill, M.D., Assistant Professor
of Pediatrics at Harvard Medical School and Research Fellow at the
Dana-Farber Cancer Institute; Z. Paul Lorenc, M.D., F.A.C.S.,
World-renowned, board-certified Aesthetic Plastic Surgeon; and
Gregory Schultz, Ph.D., Director of the Institute for Wound
Research and Professor of Obstetrics and Gynecology at the
University of Florida.
has advanced several preclinical R&D programs, building upon
the key characteristics of taurolidine. These include potent
anti-microbial activity without resistance, anti-inflammatory
properties mediated by a reduction in certain cytokines including
IL-1, IL-6 and TNF, as well as selective pro-apoptotic and
cytotoxic activity against cancer cells. Taurolidine is also known
to penetrate biofilms and retain its activity against highly
drug-resistant bacteria and fungi, making it a potentially valuable
molecule for addressing the unmet need for new anti-microbial
R&D Day event focuses on three key areas of CorMedix's
taurolidine-based pipeline:
medical devices that incorporate taurolidine
taurolidine-based therapy for cancer
development of Neutrolin for the
prevention of bloodstream infections
Development of Medical Devices that Incorporate
has focused its R&D efforts to three initial medical device
areas where taurolidine incorporation may add value and potentially
improve patient outcomes. These include:
Development of anti-microbial suture
materials to prevent surgical site infections
Development of antimicrobial
hydrogels to help prevent infections in burns and other wounds as well as treat
infections in those sites. The hydrogels may also be effective as
treatments for diabetic foot ulcers.
Development of non-woven antimicrobial
meshes to prevent infection and graft failure following
hernia repair and reconstructive surgery
2018 U.S. market is projected to be $1.7 billion for sutures, and
$1.0 billion each for hydrogels and non-woven meshes.
Development of Anti-Microbial Suture materials
successful in integrating multiple concentrations of taurolidine
(2%-10%) into monofilament suture materials, where the taurolidine
is dispersed throughout the matrix of the fibers (one prepared with
a homopolymer of epsilon-caprolactone and another fiber composed of
rho-dioxanone). Taurolidine could also be loaded onto the surface
of multifilament suture materials by integrating the drug into the
taurolidine-incorporated sutures were tested against clinically
significant bacterial species, including methicillin-resistant
Staphylococcus aureus
(MRSA), Staphylococcus
epidermidis, and Pseudomonas aeruginosa using two different
Effectiveness of the materials at eradicating these potentially
deadly microbes was confirmed using zone of inhibition (ZOI), where
bacterial growth was completely inhibited in the vicinity of the
taurolidine-loaded fibers; and by direct bacteria killing assays
that showed ~10 log (>99.9%) reduction in bacteria following
incubation with 6% taurolidine sutures.
process of testing large-scale manufacturing of polydioxanone
sutures containing 7% taurolidine that mimics the processes in use
today. It involves creating drug-loaded polymer pellets that can be
extruded in a line that enables annealing and drawing similar to
the current commercial manufacturing of sutures. Zone of inhibition
studies recently confirmed that the taurolidine sutures retain
their antimicrobial activity when manufactured by this scalable
Development of Anti-Microbial Non-Woven Meshes
non-woven mesh candidates were prepared by electrospinning using a
variety of commercially available resorbable polymer constructs and
loaded with taurolidine at strengths ranging from 21-59% by weight.
The meshes were submerged in suspended cultures of P. aeruginosa and MRSA.
Taurolidine-incorporated meshes demonstrated complete killing of
these deadly bacteria at all strengths tested in less than four
Development of Anti-Microbial Hydrogels
(HA) hydrogels containing taurolidine demonstrated complete killing
of suspended cultures of P.
aeruginosa and MRSA at all concentrations of Taurolidine
tested (1.5%-6%). Furthermore, taurolidine hydrogels were effective
at penetrating mature biofilms of P. aeruginosa on the surface of pig
skin explants. High molecular weight HA + 3% taurolidine and
myristic acid (penetration enhancer) also showed complete killing
of the biofilm bacteria.
is currently conducting proof-of-concept studies in animal models
for each of its medical device candidates, and these studies will
continue during the second half of 2017.
regulatory strategy for its taurolidine-incorporated medical
devices is to utilize the 510(k) pathway, which uses predicate