LAFAYETTE, Ind. -- The FDA has approved a clinical trial for a new and much more effective formulation of MethLock, a catheter lock solution developed by Ash Access Technology, Inc., a Lafayette, Ind. company focused on vascular access medical solutions to prevent catheter-related bloodstream infections (CRBSI).
"The FDA had approved a prior formulation of MethLock in May of 2004 for
use in a clinical trial designed to study the safety and efficacy of MethLock
as a catheter lock solution, compared with heparin, (the industry standard).
The company chose to delay the start of the trial because it felt that it
could refine the formulation to be an even more effective and faster-acting
antimicrobial," says Roland Winger, vice president of engineering and quality
assurance. "Having reached the targets we wanted, we resubmitted our formula
to the FDA, and are pleased that we have been approved to proceed with the
clinical trial, using the updated formulation."
The dominant catheter lock solution in the marketplace is currently
heparin, which is primarily an anticoagulant. In contrast, MethLock is
designed not only as an anticoagulant to minimize clotting, but also with an
antibacterial function to minimize bacterial growth and biofilm build-up
between uses of a central venous catheter. The clinical trial is designed to
prove the safety and efficacy of MethLock as a viable and preferable catheter
lock solution in dialysis applications.
The company has been working on formulating an alternative for heparin for
over five years, given the problems inherent with heparin. These problems
include thinning the blood (which sometimes causes patient bleeding); causing
an allergic reaction in some patients; leaking of heparin from the catheter
(because it has a different density from blood); and the fact that heparin
does not have antimicrobial nor anti-biofilm characteristics. Biofilm is a
thin layer of living cells, usually micro-organisms, which coat the surface of
a catheter, creating an environment for bacterial growth.
"Heparin is used over 397,000 times a day, worldwide, as a catheter lock
solution in dialysis and infusion applications alone. We feel that if we can
provide an alternative that not only prevents catheter clotting, but also
helps prevent deadly catheter-related bloodstream infections, then we can have
a significant impact on reducing patient risk of infection and containing the
rapidly rising costs of treating infections acquired in the hospital or at
home when using a catheter," says Robert B. Truitt, president and CEO of Ash
Access Technology, Inc. "We are excited to begin this clinical trial, so we
can validate the efficacy and impact of MethLock, in contrast with heparin.
If MethLock outperforms heparin in practice, to the degree we've seen in our
labs, we have created a tremendous antimicrobial, consumable product with
superior upside potential -- both for us as a company and for the patient
population plagued by infection risks."
The company reports that candidates for clinical trial sites will be
identified and finalized in the next few weeks, followed by enrollment of 400
patients slated to participate in the study. The clinical trial is expected
to begin in May and last for 26 weeks for each patient, with a subsequent 26
week follow-up period for MethLock patients. STATKING Consulting, Inc., a
Fairfield, Ohio company, specializing in data related services for clinical
trials, will be retained as the Clinical Research Organization for this trial.
Ash Access Technology, Inc. is a privately-held company founded to develop
vascular access technologies and methodologies to combat the deadly and
expensive problem of catheter-related bloodstream infections.
Source: Ash Access Technology, Inc.