A botanical drug, WH-1, has been approved for US FDA Phase II clinical trials for the treatment of diabetic foot ulcers and also potentially indicated for similar chronic wound healing management conditions.

Diabetic drug enters 2nd-stage human testing
A new Traditional Chinese Medicine (TCM) herbal medication for treating diabetic-induced chronic wounds, named WH-1, has been approved by the US FDA to enter second-stage human testing. WH-1 is composed of two Chinese herbs, including one that is relatively rare and growing in Taiwan. WH-1 has been assessed to be very competitive on the world market as a chronic wound-healing agent as it is cost effective to manufacture and has a superior  stability profile. 
 
With diabetic patients commonly suffering from slow wound healing; diabetic foot ulcers are particularly difficult to manage. Relevant pharmaceuticals in the treatment of this condition command a global market worth of about US$3 billion. In the US, Regranex is the only FDA approved diabetic foot ulcer wound healing medication, and being a protein product it is expensive (more than US$600 a 15 g tube) and has to be stored at 4oC.

WH-1 is currently under investigation in a Phase II clinical study in the treatment of Wagner grade 1 foot ulcers in diabetic patients. In order to further explore the wound healing efficacy of WH-1 in clinical applications, a randomized control study for grade 3 foot ulcers in diabetic patients will be performed. Worldwide patents of WH-1 have already been filed.

The market prospects and the advantages of WH-1
Foot ulcers are the most frequent cause of diabetes-related hospitalization. Diabetes is now the top cause of non-traumatic leg amputations in the developed world. Thus, diabetic foot ulcers and related infections result in long-term disabilities for patients with the condition and subsequent high demands on the healthcare system.

Today's aging population is also a key driver of the advanced wound management market as the elderly account for a significant portion of chronic wound-related cases. Overall, the global advanced wound care management market is about US$5 to 7 billion with steady annual market growth of around 8.3%.

In comparison to Regranex, WH-1 has similar wound healing efficacy, and being an extract of botanical material, has considerable prior human use experience. It is cost effective  to manufacture  (less than US$2 for a 15g tube) and has a stable storage profile. In addition to accelerating tissue regeneration for wound closure, WH-1 also has antiseptic and anti-inflammatory properties. With these benefits, WH-1 can be considered a promising candidate for the treatment of diabetic-induced foot ulceration, burn healing and bed sore ulceration.
 

Phase II

Worldwide patents of WH-1 have been filed: Taiwan (No. 094145941), United States (11/605,178; 11/847,220), European Union (06024463.9; 07118802.3), Japan (2007-211943), South Korea (2007-0123636), Malaysia (PI-20072012), India (1556/KOL/2007), and China.

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