Category: Press Releases

Medical Ethics and Winterbotham Darby raising awareness for better animal welfare in the food industry

Melbourne, Australia – 25 April 2019 – Medical Ethics Pty Ltd (“Medical Ethics” or “the Group”), a commercial and development company focused on pain mitigation in wounds for humans and animals, announces that it has partnered with Winterbotham Darby, a market leader in the innovation and supply of continental meats, to raise awareness to ensure better animal care standards in the food industry and show that animal welfare can go hand in hand with good business.

This year’s Animal Health and Welfare Day, hosted between Winterbotham Darby and the University of Bristol’s School of Veterinary Sciences, was dedicated to sharing methods, technology and programmes that are at the forefront of animal welfare in the supply and manufacturing of food. The event showcased a variety of collaborations between academia and industry, attracting attendance from businesses, charities, major retailers and production partners. Presentations during the fourth annual event demonstrated the pressing need to improve the welfare of commercial livestock and highlighted the dedication and passion within the industry towards enhancing animal health.

Recognised by leading veterinarians and animal welfare scientists, Medical Ethics was recognised as the first and only company to develop a safe and cost-effective solution for animals to overcome the pain associated with surgical procedures, a key priority in improving animal welfare. Tri-Solfen®, Medical Ethics’ innovative spray and stay topical local anaesthetic and antiseptic gel, is designed to adhere to wounds to provide rapid onset numbing with prolonged analgesia effects. It also contains active ingredients designed to minimise bleeding, protect against infection, coat the wound and promote healing.

In collaboration Medical Ethics and Winterbotham Darby have created the following video about the potential global role of Tri-Solfen® in improving animal care – https://medicalethics.me/multimedia/1128/

Allan Giffard, Managing Director of Medical Ethics, commented:
“It is great to hear that Tri-Solfen® is recognised by key industry leaders, such as Winterbotham Darby, as an important component in an ethical farming industry. It reinforces our belief in Tri-Solfen® as a practical pain management solution, for accidental wounds and those created by surgery, in livestock and companion animals. The product has already been used with over 100 million animals across New Zealand and Australia, and we strongly believe it has the potential to fill a large unmet need in all global markets.”

Susie White, Communications Manager of Winterbotham Darby, added:
“By taking the approach to unite the whole supply chain, from farmer and producer to customer, we have made significant progress in improving farm animal welfare across Europe. Treating animals in the best way that we can is of upmost importance to us, and this involves reducing pain during necessary surgical procedures whenever possible. As the ethical production and manufacturing of food is high on the public and personal agenda, any product that helps with improving animal care, such as Tri-Solfen®, should be considered for use when raising livestock.”

First product candidate for human use progressed for clinical development

Marks an important milestone towards building a proprietary wound care and pain mitigation platform

Melbourne, Australia – 17 December 2018 – Medical Ethics Pty Ltd (“Medical Ethics” or “the Group”), a commercial and development company focused on pain mitigation in wounds for humans and animals, announces that the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has approved its application for a Phase IIa clinical trial of Tri-Solfen® (for human use the product will be branded as Medi-Solfen®)  for the treatment of pain during the surgical debridement of venous leg ulcers.

Medi-Solfen®, Medical Ethics’ lead product candidate for human use, is an innovative medicine designed to  provide rapid onset and both short and prolonged analgesia effects for up to 24 hours. The topical gel contains two local anaesthetic agents and an antiseptic, and other active ingredients, designed to minimise bleeding and potentially protect against infection as well as promote healing.

The Phase IIa clinical trial will assess the safety and efficacy profile of Medi-Solfen® in providing anaesthesia when applied topically to venous leg ulcers, prior to and post-surgical debridement.  The open, randomised, parallel group-controlled study will be conducted in 90 patients in three successive stages, which aim to study the time taken to achieve surface anaesthesia, degree of post-operative pain relief and patient’s assessment of overall quality as an anaesthetic during this procedure.

Secondary objectives include the duration and quality of post-operative pain relief following a single-dose, levels of anaesthesia achieved, and influence on the early healing trajectory of the leg ulcer. We anticipate initiating the clinical trial in Q1 2019.

Patients with venous leg ulcers report pain to be the worst aspect of having an ulcer, especially during debridement.^1-4 Pain tolerated over a long time can cause a negative mood, decreased activities of daily living, sleep disturbance, reduced mobility and social withdrawal.⁵ In the UK alone, there are 278,000 venous leg ulcers being treated per annum, plus an additional 420,000 leg ulcers with no specific classification, however, it is broadly accepted that a number of these are venous in origin.⁶

Allan Giffard, Managing Director of Medical Ethics, commented:
“We are thrilled to announce the MHRA approval of our Phase IIa clinical trial design for Medi-Solfen® for the treatment of pain during the surgical debridement of venous leg ulcers. The application is based on an extensive body of evidence, which demonstrate the potential of Medi-Solfen® in providing a convenient, safe and effective method of pain mitigation in wounds and we look forward to investigating this further in venous leg ulcers, where there is a significant unmet patient need. This approval is an important milestone for Medical Ethics, with Medi-Solfen® being our first product candidate for human use progressed for clinical development and as we move towards building a proprietary wound care and pain mitigation platform.”

References

1. Lindholm, C., Bjellerup, M., Christensen, O. B. and Zederfeldt B. (1993) Quality of life in chronic leg ulcer patients. An assessment according to the Nottingham Health Profile. Acta Derm Venereol. Volume 73, issue 6, pp. 440-443.
2. Walshe, C. (1995) Living with a venous ulcer: a descriptive study of patients experiences. Journal of Advanced Nursing. Volume 22, issue 6, pp. 1092–100.
3. Phillips, T., Stanton, B., Provan, A. and Lew, R. (1994) A study of the impact of leg ulcers on quality of life: Financial, social and psychologic implications. Journal of American Academy of Dermatology. Volume 31, issue 1, pp. 49–53.
4. Moffatt, C. (2002) Pain at wound dressing changes. EWMA positioning document.
5. Franks, P.J. and Moffatt, C. (2001) Health related quality of life in patients with venous ulceration: use of the Nottingham health profile. Quality of Life Research. Volume 10, issue 8, pp. 693-700.
6. Guest J., Fuller, G.W., and Vowden P. (2018) Venous leg ulcer management in clinical practice in the UK: costs and outcomes. International Wound Journa;18:29-37l

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Contacts:
Medical Ethics Pty Ltd
Allan Giffard, Managing Director
Charles Olsson, Marketing Director

Notes for editors:
About Medical Ethics Pty Ltd
Medical Ethics Pty Ltd is a commercial and development company focused on pain mitigation in wounds for humans and animals. Our vision is to develop and deliver our proprietary highly effective, safe, affordable and practical pain relief platform to prevent pain and minimise suffering associated with wounds in humans, livestock and companion animals. Medical Ethics is focused on the development of the Group’s patented technology initially for the treatment of chronic wounds such as diabetic leg ulcers. Animal Ethics, a wholly owned subsidiary of Medical Ethics, is the first, and currently the only, company globally to develop, launch and commercialise a topical pain and wound management product for use in livestock undergoing painful husbandry procedures.

About Tri-Solfen^® (to be known as Medi-Solfen^® in humans)
Medi-Solfen^® is a local anaesthetic and antiseptic gel. Medi-Solfen^® contains two proven topical local anaesthetics; fast-acting Lidocaine for immediate pain relief and long-acting Bupivacaine for prolonged post-operative pain relief. Adrenaline is included for its ability to reduce the shock and stress of blood loss, whilst prolonging the anaesthetic action. Medi-Solfen^® also contains Cetrimide; an antiseptic widely used to cleanse skin and wounds and provides protection from bacterial contamination.

For further information, please visit http://medicalethics.me

New collaboration to advance animal wellbeing

Leader in animal wellbeing solutions, Medical Ethics Pty Ltd, and animal nutrition provider, 4 Season Company, have established a new collaboration to trial pain mitigation technologies via a unique feed supplement.

The research and development studies will involve incorporating a pain relief agent that is similar to human over-the-counter anti-inflammatory drugs, into a specially formulated feed supplement based on a unique molasses mineral block technology.

Bayer through its Care4Cattle initiative has awarded one of its three prestigious global grants to Dr. Dominique van der Saag and the Sydney University Veterinarian Science Faculty. The grant will assist Medical Ethics and 4 Season Company to commence the first stage of the proof of concept studies.

Medical Ethics and 4 Season Company are working together to develop the technology that has the potential to deliver a range of pain mitigation therapies for livestock undergoing routine surgical procedures such as castration, disbudding, and to assist in the recovery from other painful ailments such as hoof abscesses. The technology also has the potential to help reduce pain and stress to cows during calving.

Managing Director of Medical Ethics, Allan Giffard, commented:

“Whilst the technology is still in the early stages this announcement was one of the company’s most significant animal wellbeing initiatives since the commercialisation of the Tri-Solfen pain mitigation technology. The awarding of the prestigious Bayer grant to our research partners Sydney University indicates the enormous potential the technology has to improve animal wellbeing outcomes globally.

“Currently there are no products providing pain relief in a simple, accessible form for animals to self-medicate. The combination of the Tri-Solfen technology (protected by 35 patents globally) and the introduction of the pain mitigated infused feed supplement has the potential to provide a practical, cost efficient and highly effective pain mitigation combination.

“This latest initiative is an important addition to our growing research and development pipeline.”

Bayer Regulatory Affairs Manager and Animal Well-Being Lead, Cate McPherson commented:

“Bayer Australia is thrilled that Dr van der Saag has been awarded a Care4Cattle grant for this innovation in advancing the well-being of cattle. Coming in the wake of the recent approval of Tri-Solfen for the new claim in disbudding and dehorning in calves, this grant underlines Bayer’s commitment to support ethical and sustainable practices in Australia’s animal industries”

In May, Medical Ethics announced it was investing $5.3 million (AUD) in researching the use of its Tri-Solfen pain mitigation technology for treatment of wounds in humans. Since commercialisation, Tri-Solfen has treated over 80 million farm animals in Australia.

 

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Contact:

Allan Giffard, Managing Director, Medical Ethics
0419 362 286

Celia Moore, FTI Consulting
0432 344 069

 

Notes for editors:

About Medical Ethics Pty Ltd
Medical Ethics Pty Ltd is a commercial and development company focused on pain mitigation in wounds for humans and animals. Our vision is to develop and deliver our proprietary highly effective, safe, affordable and practical pain relief platform to prevent pain and minimise suffering associated with wounds in humans, livestock and companion animals. Medical Ethics is focused on the development of the Group’s patented technology initially for the treatment of chronic wounds such as diabetic leg ulcers. Animal Ethics, a wholly owned subsidiary of Medical Ethics, is the first, and currently the only, company globally to develop, launch and commercialise a topical pain and wound management product for use in livestock undergoing painful husbandry procedures.

For further information, please visit http://medicalethics.me

About 4 Seasons Company
For further information, please visit https://www.fourseasonco.com.au/