In addition, KGF-2 has completed successful Phase I studies to evaluate its safety as a systemically administered treatment. Phase II efficacy studies under this separate IND will be pursued during 1999. In the U.S., an estimated 500,000 patients experience venous ulcers each year. Venous ulcers are lesions on the skin of the ankle or lower leg caused by chronic venous insufficiency. This leads to pooling of blood in the extremities, causing swelling, or edema, and mild redness and scaling of the skin, often over a varicose vein.
Ulceration gradually develops as the skin becomes inflamed.
The current therapy for these wounds is most often debridement, compression and management of infection. Current treatment for venous ulcers often extends for several months and frequently ends without success. Phase I human clinical studies found that topically applied KGF-2 was safe and well tolerated in healthy human subjects at doses above those proposed for subsequent clinical studies. None of the subjects withdrew from the study or required dose modification because of adverse effects. In a planned expansion of its clinical development program, HGSI anticipates filing for permission, during 1999, to bring additional novel drug candidates forward to human clinical testing.