Testimonials

Since Tri-Solfen^® was commercially launched, over 150 million lambs have been treated and over 80% of Australian wool growers are now using Tri-Solfen for their sheep. Here’s what some of them have to say…

‘We have used pain relief for two years now and seen real production gains. We are concerned for the welfare of our animals and will continue to use pain relief to ensure they get the best care.’

Clinton Wise– Wililoo Merino Stud, Woodanilling, W.A.

'It easy to see the difference pain relief makes. Before, lambs would walk away hunched up, even taking a couple of hours to walk back to the paddock. Now they run straight back to Mum and start suckling,” says Rod. “My wool is now sold under the Better Choices brand. I see this as a definite advantage. I think it will be an advantage in the long run, to both me and the industry as a whole.'

Rod Miller– Glenpaen Merino Stud, Horsham, Vic

'After being treated with pain relief my lambs were more content and less stressed. As farmers we are sincere in looking after the welfare of our animals and using pain relief demonstrates this.'

Richard Coole– Frankland, W.A.

'We have been using pain relief for the past three years. We’re impressed by reduced bleeding in the mulesing wound immediately after application. Lambs run straight back to find the ewe, which has dramatically reduced our mortality rates. Flock management, post lamb marking is easier due to the effect of pain relief and the scab healing faster.'

Ryan & Malcom O’Dea– Peepingee Merino Stud, Narrogin, W.A.

'Using pain relief eases the stress and allows lambs to mother up and move back to the paddock easier with faster weight gains.'

Kent Lummis– Waverley Downs, Gilgandra, NSW

Country	Species	Patent
Australia	Sheep	Granted
Australia	Horses, Dogs, Lab animals	Granted
Australia	Cattle	Granted
Australia	Humans	Granted
New Zealand	Sheep, Cattle	Granted
New Zealand	Horses, Dogs, Lab animals	Granted
EU	Humans	Granted
EU	Pig, Sheep, Cattle	Granted
USA	Dogs, Horses, Lab animals	Granted
USA	Humans	Granted
USA	Pig, Sheep, Cattle	Granted
Canada	Horses, Dogs, Lab animals	Granted
Canada	Cattle, Pig	Granted
Canada	Humans	Granted

Advisory Board

Ian Page

Non-Executive Director

Ian is Chief Executive Officer of Dechra Pharmaceuticals, which has a 33% shareholder in Medical Ethics. He joined National Veterinary Services, Dechra’s former services business in 1989 and joined the Board of Dechra in 1997. In October 2010, Ian was appointed as Non-Executive Chairman of Sanford DeLand Asset Management.

Dr Chris Roberts

Human Wound and Regulatory Advisor

Chris has over 20 years’ line management experience of heading clinical research teams. He was previously global head of Smith & Nephew clinical support and market development, where he managed global clinical Phase II and III programmes in the management of venous and pressure ulcers.

Lieutenant Colonel Professor Steven Jeffery

Medical Specialist Advisor

Steve has over 15 years’ experience in military plastic surgery. In 2011 he was awarded the Military Civilian Partnership Award for ‘Regular of the Year’, as well as receiving the Wounds UK ‘Key Contribution’ award and the Smith and Nephew ‘Customer Pioneer of the Year’ award. He has also been awarded Fellowship of the Royal College of Surgeons of England ad eundum. He is an expert adviser to NICE Medical Technologies Evaluation Programme. Steve co-founded the Woundcare 4 Heroes charity, which is already making a big difference to the wound care of both serving and veteran personnel.

Dr Matthew Bayfield

Medical Specialist Scientific Director

Dr Matthew Bayfield, Head of Cardiothoracic Surgery, Strathfield Private Hospital and VMO Cardiothoracic Surgeon, Royal Prince Alfred Hospital.

Professor Peter Windsor

Veterinarian Research Advisor

Peter is a registered specialist veterinary surgeon in New South Wales and an emeritus Professor at Sydney University. He holds a BVSc (Hons), PhD, DVSc and diploma from the European College of Small Ruminant Health Management.

Dr Julian Braidwood

Global Regulatory Affairs Advisor

Julian has held leadership roles and managed international clinical projects with Grampian. He was previously Regulatory Affairs Manager at Novartis Animal Health. He is the Founder and Managing Director of Triveritas, where he is responsible for a team of 40 animal health specialists across the EU and the US.

Press Release

The MHRA approves Phase IIa clinical trial application for Tri-Solfen® for venous leg ulcers

December 17, 2018

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

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.
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.
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.
Moffatt, C. (2002) Pain at wound dressing changes. EWMA positioning document.
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.
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

– Ends –

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

Tel: +61 419 362 286

FTI Consulting
Brett Pollard / Victoria Foster Mitchell

Tel: +44 20 3727 1000

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

Further information

Medical Ethics:

Allan Giffard, Managing Director
Charles Olsson, Marketing Director
+61 419 362 286

FTI Consulting:

Brett Pollard, Victoria Foster Mitchell
+44 (0)20 3727 1000

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