Kane Biotech Inc. announces that it has successfully prepared its first batch of DispersinB® wound care hydrogel, intended for use in pre-clinical studies which will begin this quarter. This novel formulation, based on a recently filed patent application, both significantly reduces manufacturing complexities and provides long term stability and shelf-life to the gel.
In addition, the Company is pleased to announce a new manufacturing partnership with Dow Development Laboratories, LLC ("DDL”) to scale up the process and, ultimately, manufacture materials under Good Manufacturing Practices (GMP) for a first-in-human proof of concept trial. Specifically, DDL will be responsible for manufacturing clinical batches of DispersinB® hydrogel to be used for a randomized study planned for 2022 on patients suffering from multiple chronic wound types to establish safety and efficacy.
Product manufacturing is a key milestone in Kane’s DispersinB® wound care project which is financially backed by both Western Economic Diversification Canada and The Medical Technology Enterprise Consortium (“MTEC”), a biomedical consortium overseen by the US Army. In addition, Kane is developing its own internal quality system to meet the ISO 13485 standards required for the design and development of medical devices.