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This project is the most advanced of the Company’s R&D portfolio. A Phase I (safety clinical study) has been completed. This clinical study was a preliminary assessment of the safety of MD 920 when adsorbed onto a proprietary dressing, which in turn was used as part of a 4 layered compression bandage system in patients who had chronic lower limb venous ulceration. The study demonstrated that further clinical evaluation of Aus Bio’s MD 920 / 921 wound healing programme should continue. Compared to historical controls, superior healing was noted and no evidence of local or systemic toxicity.
Chronic Venous Ulcers
Chronic venous ulcers (CVU’s), associated with lower limb chronic venous insufficiency (varicose veins), are the most common cause of chronic lower limb ulceration affecting up to 2% of Western populations. Current “Gold Standard” management of these ulcers comprises compression bandaging, foot elevation and local topical ulcer care. Venous ulcers may heal within a six month time frame of optimized care. However, ideal management does not always occur and 12 month prospective studies have shown that healing rates may be as low as 25%. Industry sources suggest that venous leg ulcers:
- are a major chronic health issue in the aged community.
- significant cause of pain, immobility and decreased quality of life
- costs the healthcare community AUD$300 million to $500 million per annum
- perhaps only 25% are treated with an effective protocol
A Phase I study usually involves 10 – 30 clinical subjects, often healthy volunteers. These studies look at issues of drug safety. Phase II studies involve the recruitment of up to several hundred patients with the target disease and evaluate drug efficacy and side effects and other safety issues.
Following successful completion of a Phase II study the drug candidate will enter a more costly Phase III study which is necessary for drug registration in Western countries. These studies look closer at comparable efficacy against currently used drugs for the same disease condition, and quantitate outcomes of efficacy and safety over longer time periods.
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Aus Bio Clinical Trial Patient with difficult to heal chronic venous ulcer
51 year old female, long history unhealed chronic venous ulcer. Large and painful. Commenced MD 920 treatment with nurse supervised compression bandaging. Ulcer healed promptly over 11 weeks. Remained healed at 20 week follow up.
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