Great Lakes Pharmaceuticals, Inc. has announced the initiation of the clinical study of the first Company product, the antimicrobial lock solution, B-Lock™.
The prospective, randomized, active control clinical investigation is being conducted in 22 clinical sites in Hungary and Poland and will involve up to 400 patients on renal dialysis who require a central venous catheter for vascular access.
The Company expects a wealth of clinical safety and efficacy data based on up to 45,000 catheter-days observations. If successful, the clinical data will be used for CE Mark approval in the European Union.
B-Lock™ is the first antimicrobial catheter lock solution which in pre-clinical testing demonstrated fast acting biocidal activity against variety of clinically important bacteria and fungal strains including methicillin sensitive and resistant strains of Staphylococcus aureus and epidermitis, vancomycin resistant Enterococcus (VRE), strains of Pseudomonas, Klebsiella, Acinetobacter, and Candida, in both planktonic and biofilm forms.
Microbial biofilms commonly colonize indwelling catheters, are resistant to standard antibiotic treatments, and frequently lead to complicated bloodstream infections.
Moreover, in preclinical studies, B-Lock™ demonstrated anti-thrombotic and anti-occlusive activity and is expected to significantly reduce the incidence of both, Central Line-Associated Bloodstream Infections (CLABSI) and occlusive malfunction of central venous catheters.
Central venous catheters (CVC) facilitate the administration of various therapeutic agents such as chemotherapy for cancers and serious soft tissue and bone infections, as well as, other important clinical functions such as renal dialysis or parenteral nutrition.
However, the use of catheters is also associated with infectious complications and catheter occlusion.
The Centers for Disease Control and Prevention (CDC) estimates the annual incidence of CLABSI cases at 250,000 with up to 25% mortality with the cost to the healthcare system exceeding $4.6 billion per year.
"Initiation of the clinical investigation of B-Lock™ is an important milestone for Great Lakes Pharmaceuticals," said Krzysztof Appelt, Ph.D, President and Chief Executive Officer.
Appelt continued, "It brings us a step closer to making this promising product available to the patients and their caregivers. If approved, B-Lock™ is expected to become the standard of care for both hospital and outpatient applications, greatly reducing patients' suffering, the rate of CLABSI, and the serious and costly medical consequences of these potentially life-threatening infections."
"We are very excited and pleased about our ability to initiate this important study," continues John Cheronis, M.D. Ph.D., Chief Medical Officer.
Cheronis continued, "We believe that this study will be ground breaking with respect to our understanding of catheter-derived infections and the role of biofilms in the development of occlusive malfunction. A reduction of the incidence of CLABSI and other forms of catheter dysfunction will be a significant advance for all patients requiring a central venous catheter."