LONDON, June 10, 2015 /PRNewswire/ —
Edixomed, the clinical-stage biopharmaceutical company developing and commercialising innovative nitric oxide generating wound care technology, presented their interim data from the ProNOx 1 study at the 7th International Symposium on the Diabetic Foot, The Hague, May 2015.
The interim results demonstrated compelling evidence for healing chronic diabetic foot ulcers. The study established: Completely healed wounds treated with the Company’s nitric oxide generating dressing (NOx) is double that of standard of care (SOC) [p<0.01]
- Almost 2/3 patient’s ulcers decreased in area by more than 90% using the NOx dressing compared to 1/3 treated in SOC
- Only 3% of NOx treated patients wounds materially worsened compared to 34% of SOC [p<0.01]
Professor Mike Edmonds, Consultant Diabetologist, Kings College Hospital, London said, “I believe 2 key challenges to overcome for successful healing in diabetic foot ulcers are ischaemia and infection. This dressing may address both of these issues and the improved healing seen in the interim data suggests the dressing may have real potential.”
Dr Brian Kennon, Consultant Diabetologist, Southern General, Glasgow, adds, “If in addition to improving ulcer healing time this dressing is shown to reduce the number of amputations and serious life-threatening complications of foot disease, then clearly this will be a major advance.”
Professor David G. Armstrong Professor of Surgery, University of Arizona said “This technology potentially represents a significant breakthrough in the treatment of diabetic foot ulcers, offering a simple, easy to apply dressing that, preliminarily, appears to show promise. If this progress continues, then we think the ultimate beneficiary will be our patients.”
Of equal importance is the avoidance of serious adverse health outcomes:
- In the SOC treated patients there have been 9 index ulcer-related serious adverse events; 3 below the knee amputations and 6 hospitalisations for serious infection, osteomyelitis or cellulitis
- In NOx patients there have been no index ulcer-related serious adverse events.
Diabetic foot ulcers are one of the most significant, prevalent and recurring co-morbidities of diabetes, and unhealed diabetic foot ulcers can lead to amputation and severe disability. The diabetic wound care market is estimated to be over $5 billion worldwide, and according to http://www.DiabeticFootOnline.com every 20 seconds someone in the world loses a limb due to complications of diabetes. Currently the NHS in England spends an estimated £639 million, 0.7% of its budget, on diabetic foot ulceration and amputation.
“This is beneficial to the patient but has important advantages for funding costs of health services. The ability to reduce the burden on the patient and the health service provides strong health economic reasons for adoption of this innovative technology, which could revolutionise the management of diabetic foot wounds and create positive change for these patients,” says Syd Hanna, Edixomed’s CEO.
The ProNOx1 study is a randomised controlled clinical study in chronic DFUs, recruiting 120 patients in ten leading sites across the UK. An interim analysis has been performed on the first 51 patients recruited, who have healed or completed 12 weeks of treatment with the NOx dressing or standard of care (NOx n=30; SOC n=21). The 2 groups were very similar with regard to age, original ulcer size and length of time that the ulcer had been present. The analysis compared the area of the wound at baseline to that of the wound after 12 weeks of treatment or until completely healed, whichever was earlier.
The study anticipates being fully recruited shortly with final evaluation by year end.