Project MD 920
The Development of Novel Wound Healing Compounds for Chronic Wounds and Lower Limb Venous Ulceration
This project is the most advanced of the Company’s R & D portfolio. A Phase I (Safety) Clinical Study was completed during May, 2005. This uncontrolled and unblinded 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. This study will use known historical clinical data evidence to gauge results of early wound healing efficacy.
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.
It is generally accepted that an individual project valuation increases, as a potential drug candidate progress through the Phase II clinical trial process.
A final report on the results of this Phase I study is not expected until later this year. To date the Company has not received any repeated reports from preliminary data analysis that indicates that:
- MD 920 has been causally related to any significant systemic adverse events
- MD 920 has been detected in patients’ blood stream
- MD 920 dressings have been associated with local adverse effects
- MD 920 has caused abnormal laboratory results.
Discussions with Industry indicate that any product, such as MD 920, that assists in reducing the costs associated with treating chronic venous ulcers and improves healing rates, “will have a solid probability of accessing a relevant share of the treatment costs of this disease process”.
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.
Before treatment with MD 920
11 weeks after MD 920 treatment
Planning is well advanced for a Phase II Clinical Study, subject to regulatory approval.