Title of Project: DispersinB® the missing link in wound care – Clinical evaluation of DispersinB® to treat biofilm mediated antimicrobial resistance in non-healing chronic wound infections
Project Team (including major subs): Kane Biotech Inc., Subs: Charles Rivers Laboratories, Southwest Regional Wound Care Center (SRWCC)
Award Amount: $2,652,247
Project Duration: 3 years
Project Objective: The objective of the proposed project is to evaluate the stability, preclinical safety, clinical safety, efficacy and usability of the DispersinB® wound gel prototype. The specific aims of this project are:
1. Stability studies: Kane Biotech will conduct stability studies (accelerated and real time) on the final DispersinB® gel, examining the stability of the prototype across a range of temperatures for a minimum of 12 months.
2. Preclinical studies: Studies examining biocompatibility and toxicity of the DispersinB® prototype both in vitro and in vivo will be conducted by Charles Rivers Laboratories.
3. Proof of Concept study: Studies examining the efficacy, safety (pharmacokinetics) of DispersinB® gel in a chronic wound pig model will be conducted by Charles Rivers Laboratories
4. Clinical safety study: A human safety study will monitor safety following the application of DispersinB® gel on multiple chronic wound types. This will be a randomized open label study, conducted at the Southwest Regional Wound Care Center.
5. Usability study: A human usability study will examine the ease of using/applying/wearing the DispersinB® topical gel for end users (clinicians and wound care patients). This study will be conducted in conjunction with the safety study at the Southwest Regional Wound Care Center.