Diabetic wound healing is a very large, and historically very challenging, market. Almost one in ten adults in the world are diabetic or pre-diabetic1. In the United States alone, there are almost 30 million diabetics2, and over 85 million people with prediabetes2. On average 25% of diabetics will develop a significant lower extremity wound (diabetic foot ulcer or DFU) in their lifetime3. Up to 70% of all lower limb amputations globally are in diabetics, with an amputation somewhere in the world every 30 seconds, some 85% of which are believed to be preventable through proper wound care4. Nearly half of the individuals who have an amputation due to vascular disease will die within 5 years. This is higher than the five year mortality rates for breast cancer, colon cancer, and prostate cancer5.
In work done at The Mayer Institute, a leading center for advanced diabetic wound treatment, Delivra’s transdermal cream delivery system is at the core of a new therapeutic modality that has shown promising results for diabetic patients. Specifically, the tetracycline antibiotic known as doxycycline hyclate, has been formulated in the Delivra system for application to diabetic, lower limb wounds.
“What we are trying to facilitate here is an effective treatment for a pervasive global issue, with enormous economic and personal consequences”, said Chris Schnarr, President of Delivra. “At a higher level, diabetes is a complex disease which manifests itself in many different ways. We believe that, in addition to our leading diabetic neuropathy product sold under the LivReliefTM brand in pharmacies across Canada, our technology can facilitate a strong suite of treatment options for diabetes and diabetes-related conditions. This doxycycline work is our first significant step in that direction, with additional solutions, both natural and pharmaceutical, now actively moving through our development pipeline. This is also an early but excellent example of our ability to re-energize existing or mothballed drugs through a more effective delivery modality, and to re-purpose drugs for new uses via the transdermal route to open market opportunities that were not available via oral administration.”
Originally developed by Pfizer Inc. and sold under the brand name Vibramycin®, doxycycline has been an effective and globally prescribed oral and intravenous broad-spectrum antibiotic for a wide range of indications for almost 50 years. There has also been a persistent view that doxycycline could comprise an effective treatment for additional indications in a topical format, although such a market has yet to develop. In this case, the unique ability of the Delivra system to penetrate and deliver the pharmaceutical agent deep into the wound bed is believed to be a key contributor to the efficacy of the solution. Further, the doxycycline molecule is notoriously unstable and oxidizes rapidly, which is challenging for traditional topical formulations. The proprietary Delivra system, through its unique multi-layer molecular encapsulation technology and the range of antioxidant ingredients within the emollient base, has been shown to effectively stabilize doxycycline for extended time periods. Delivra has filed a provisional United States patent on its doxycycline formulation.
Dr. Perry Mayer of The Mayer Institute said “Wound healing is the core focus of my professional practice. I’ve seen far too many needless amputations to have it be otherwise. Over the past 15 years, I have seen perhaps 40,000 DFU patients, and I have seen hundreds of treatment modalities come and go. I am excited about the results we are seeing with Delivra, in terms of efficacy, simplicity, and patient cost. We will do additional studies on this solution, but to date, the results have been very impressive, in particular with difficult wounds that were not responding to conventional treatment modalities”.
Wound healing professionals and diabetic clinicians are encouraged to contact Dr. Perry Mayer to discuss his work with doxycycline and Delivra. Authorized prescribers can source doxycycline, compounded in Delivra, through the pharmacy services of NKS Health, in Canada. It is expected that the cost of a one month treatment course will be in the CDN$175 range, versus other treatment modalities that range from CDN$200 up to CDN$1,000 per month.
Delivra will now work with Dr. Perry Mayer and other leading clinicians in North America to plan a large and formal clinical trial on this treatment modality, to prepare an enhanced dossier for potential regulatory filings and approval as a mass produced and packaged general pharmaceutical product. In the interim, Delivra will also seek commercial licensing partners who have an interest in undertaking regulatory, production, and distribution activities on a global basis.
ABOUT THE MAYER INSTITUTE
Formed by Dr. Perry Mayer in 2006 to concentrate on the treatment of the diabetic foot, The Mayer Institute (“TMI”) has become a leading centre in the diabetic field, with over 16,000 patient visits per year, 9000 of those visits being for diabetic wound care. The Mayer Institute delivers world-class, evidence based diabetic foot and wound care combined with aggressive education. Moving away from the standard sick model (where response is delayed and reactionary) and towards a preventative care model (where outcomes are anticipated and resources leveraged), TMI empowers its patients with customized treatment strategies and highly personalized attention. TMI’s evolutionary approach combines leading practices; the latest technology and equipment; experienced and skilled practitioners; and a network of experts and technicians in related medical fields. Among other initiatives, Dr. Mayer is currently spearheading the development of The Canadian Diabetic Foot Collaborative, a national network of clinicians interested in the treatment of diabetic foot disease.
ABOUT NKS HEALTH
Serving patients and clinicians across Canada, NKS Health is a unique, specialty pharmaceutical services company that focuses completely on compounded, infused, injectable and biologic medications. NKS combines combine expert training in biologic medications and compounded, infused or injected medications as well as HIV/Hepatitis medication management, but also disease state management, medication management, and awareness for the patient and physician. NKS couples this with compliance tracking, nutritional support and outstanding customer service. This improves overall patient care, improves patient compliance and ultimately leads to better health.
ABOUT DELIVRA CORP.
Delivra Corp. is a developer of transdermal technologies for the delivery of pharmaceutical and natural molecules through the skin, rather than via pills. Delivra manufactures and sells a growing line of natural topical creams under the LivReliefTM brand, for conditions such as joint and muscle pain, nerve pain, varicose veins, wound healing, and sports performance. LivReliefTM products are available in pharmacies, grocery chains, and independent health food stores across Canada, and on-line at www.livrelief.com. In parallel with its consumer products business, Delivra also has a mandate to license its unique, proven, and patent-pending delivery platform to global pharmaceutical companies for the transdermal delivery of third party active ingredients to treat a broad range of conditions. With a global transdermal drug delivery market forecast to grow to USD $40 billion by 2018 (Source: Kelly Scientific), Delivra believes the licensing opportunity is robust. Delivra is headquartered in Burlington, Ontario and has a research and development laboratory in Charlottetown, PEI.
- Fact Sheet #312, World Health Organization.
- National Diabetes Statistics Report, 2014, American Diabetes Association.
- Wound Management in Diabetic Foot Ulcers, Wounds International, 2013.
- Diabetes and Foot Care: Time to Act, International Diabetes Foundation and the International Working Group on the Diabetic Foot, 2005.
- Journal of the American Podiatric Medical Association, November 2008
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Certain information in this press release may constitute forward-looking information. This information is based on current expectations that are subject to significant risks and uncertainties that are difficult to predict. Actual results might differ materially from results suggested in any forward-looking statements. The Corporation assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those reflected in the forward looking-statements unless and until required by securities laws applicable to the Corporation. Additional information identifying risks and uncertainties is contained in the Corporation’s filings with the Canadian securities regulators, which filings are available at www.sedar.com.
For more information, please contact:
Chris Schnarr, President and CFO