LAFAYETTE, Ind., March 22 /PRNewswire/ -- 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, Indiana 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, 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 buildup 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. Dr. Stephen R. Ash, Chairman and Director, Research and Development, is a practicing Nephrologist with the Arnett Clinic in Lafayette, Indiana, and is a world- recognized researcher and patent holder in extracorporeal devices, sorbent chemistry, and vascular and peritoneal access devices. Ash Access Technology is located in Lafayette, Indiana in the INOK Business Center.
This press release contains forward-looking statements, which if not based on historical facts, involve risks and uncertainties. Our actual results may differ materially from the results or events stated in the forward-looking statements, including, but not limited to, certain events not within the Company's control.
Ash Access Technology, Inc.