DFU-884 for the Treatment of Diabetic Foot Ulcer

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Hepatocyte Growth Factor (HGF)

This gene encodes a protein that binds to the hepatocyte growth factor receptor to regulate cell growth, cell motility and morphogenesis in numerous cell and tissue types. Alternative splicing results in multiple transcript variants, at least one of which encodes a preproprotein that is proteolytically processed to generate alpha and beta chains, which form the mature heterodimer. This protein is secreted by mesenchymal cells and acts as a multi-functional cytokine on cells of mainly epithelial origin. This protein also plays a role in angiogenesis, tumorogenesis, and tissue regeneration. Although the encoded protein is a member of the peptidase S1 family of serine proteases, it lacks peptidase activity. Mutations in this gene are associated with nonsyndromic hearing loss.

Diabetic Foot Ulcers

Foot ulcers and complications thereof are a leading cause of hospitalization and lower extremity amputation among patients with diabetes. 10-15% of diabetic individuals are at risk of developing ulcers. Infected diabetic foot ulcers were responsible for more than 80% of all amputations in the US from 2005 to 2010. In the US, diabetic foot ulcers generate costs in excess of USD 1 billion, including costs to Medicare and private insurers of approximately USD 9-13 million per year.

The initial lesion may result from acute trauma, injury or from chronic mechanical stress. The development of wounds and ulcers of the lower extremities in diabetic patients is complicated because of neuropathy. Distal ischemia secondary to peripheral vascular disease is another potential cause of ulceration, and is an important risk factor for amputation. Early identification and treatment of wounds are key to the avoidance of infection, as infectious complications can be life- or limb-threatening. When infection does develop, identification of the infecting microorganism is essential for selection of the appropriate antimicrobial agent, since improperly treated skin infections have the potential to spread to bone, resulting in osteomyelitis. Even in the absence of infection, severe foot wounds are extremely slow to heal due to deficiencies in the intrinsic wound-healing system of diabetic patients.

Inducing Angiogenesis to Improve the Microcirculation

The Status of DFU-884

The international patent applications under the PCT have been granted.

	Discovery/Optimization	Preclinical	Clinical
DFU-884