Kane Biotech announces two key milestones as DispersinB® wound care project advances towards human clinical trials
- Development of a novel topical hydrogel formulation of DispersinB® with significantly improved stability
- New manufacturing partnership with Dow Development Laboratories, LLC for clinical product manufacturing
WINNIPEG, Manitoba, July 13, 2021 (GLOBE NEWSWIRE) — 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.
“These important milestones for Kane are in line with our strategy of further accelerating DispersinB® -based products,” commented Marc Edwards, Kane’s CEO. It is exciting to finally have a DispersinB® product in hand, especially knowing how important it is for patients to find a way to treat biofilm-infected wounds. Our new in-house manufacturing capabilities will enable us to accelerate all of Kane’s product development activities beyond DispersinB® for the wound care markets.”
“Kane is the ideal partner to leverage our depth of knowledge in topical product development, as well as our experience and scientific expertise,” said Debra Dow, President & CEO with DDL. “We look forward to supporting Kane in the development of top-quality DispersinB® hydrogel and other products while building a long-term successful relationship.”
Wound care is currently one of the most expensive areas of health care with multiple complex solutions. Chronic wounds present a significant financial burden to the U.S. healthcare system. Studies of Medicare data estimate the cost to treat these wounds at between $28 billion and $32 billion. The treatment of chronic wounds is a major challenge for health care providers, with a high failure rate leading to amputation, sepsis and death. One of the major reasons for this failure is the formation of bacterial biofilms, which are present in over 70% of chronic wounds. Biofilm formation can make bacteria up to 1000 times more resistant to antibiotics, antimicrobial agents, disinfectants and the host immune system. Ultimately, DispersinB® hydrogel will significantly increase the ability of healthcare providers to effectively treat wound infections and complement other treatments by improving their activity and efficacy considerably through the removal of bacterial biofilm.
Kane’s patented, antibiofilm DispersinB® technology specifically targets the building blocks of biofilm, destroying the exopolymeric matrix rendering bacteria and yeast susceptible to known antimicrobials. DispersinB® has repeatedly demonstrated efficacy, safety and stability both in vitro and in vivo.
Watch Kane’s latest 2021 business update video here.
About Dow Development Labs, LLC
Dow Development Labs, LLC specializes in the development, manufacture and testing of topical drug products. FDA-registered, cGMP compliant and occupying a 23,000 square foot custom-built facility in Northern California, DDL has expertise and experience developing topical products and medical devices for a wide array of therapeutic indications including wound care.
About Kane Biotech
Kane Biotech is a biotechnology company engaged in the research, development and commercialization of technologies and products that prevent and remove microbial biofilms. The Company has a portfolio of biotechnologies, intellectual property (54 patents and patents pending, trade secrets and trademarks) and products developed by the Company’s own biofilm research expertise and acquired from leading research institutions. StrixNB™, DispersinB®, Aledex™, bluestem™, bluestem®, silkstem™, goldstem™, coactiv+™, coactive+®, DermaKB™ and DermaKB Biofilm™ are trademarks of Kane Biotech Inc. The Company is listed on the TSX Venture Exchange under the symbol “KNE” and on the OTCQB Venture Market under the symbol “KNBIF”.
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Caution Regarding Forward-Looking Information
This press release contains certain statements regarding Kane Biotech Inc. that constitute forward-looking information under applicable securities law. These statements reflect management’s current beliefs and are based on information currently available to management. Certain material factors or assumptions are applied in making forward-looking statements, and actual results may differ materially from those expressed or implied in such statements. These risks and uncertainties include, but are not limited to, risks relating to the Company’s: (a) financial condition, including lack of significant revenues to date and reliance on equity and other financing; (b) business, including its early stage of development, government regulation, market acceptance for its products, rapid technological change and dependence on key personnel; (c) intellectual property including the ability of the Company to protect its intellectual property and dependence on its strategic partners; and (d) capital structure, including its lack of dividends on its common shares, volatility of the market price of its common shares and public company costs. Further information about these and other risks and uncertainties can be found in the disclosure documents filed by the Company with applicable securities regulatory authorities, available at www.sedar.com. The Company cautions that the foregoing list of factors that may affect future results is not exhaustive.