Military Infectious Disease – Prototype Innovation Program (MID-PIP)
The Joint Program Committee (JPC)-2/Military Infectious Disease Research Program (MIDRP) is one of six major Defense Health Program (DHP) core research program areas within the DHP medical Research Development Test & Evaluation (RDT&E). JPC-2 is a committee of Department of Defense (DoD) and non-DoD medical and military technical experts in infectious disease-related program areas. Per the program’s mission statement, JPC-2/MIDRP seeks to plan, coordinate and oversee for the DoD, a focused and responsive world class infectious diseases Science and Technology (S&T) program, leading to fielding of effective, improved means of protection and treatment to maintain effective global operational capability by maximizing Warfighter readiness and performance.
This program aims to advance solutions in relation to the following focus areas:
- A point-of-care device to detect the presence of microbial infection.
- Generation of high affinity monoclonal antibodies to four bacterial antigens for the prevention and treatment of bacterial wound infections and sepsis
- A single administration escape-resistant therapy for HIV control
- Clinical evaluation of products to treat biofilm-mediated antibiotic-resistant infections in non-healing chronic wounds
The research project award recipient was selected from the Offerors who responded to MTEC’s Request for Project Proposals (19-10-MID-PIP).
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.