Safety and efficacy of rh-Lactoferrin in Diabetic Ulcers

DESCRIPTION (provided by applicant): Research Objectives: Determine the safety, pharmacokinetics, pharmacodynamics, and efficacy of topical recombinant human lactoferrin (rhLF) in promoting healing in diabetic ulcers. There are 7.5 million US patients with chronic skin wounds with annual health care costs of $5-9 billion; diabetic ulcers alone cost $4 billion. Current therapies are inadequate with diabetic patients often developing gangrene and needing amputation. Topical rhLF significantly enhanced wound healing in a mouse model, outperforming placebo as well as Regranex, the only biologic approved for chronic wounds. RhLF appears safe and well tolerated in humans, having been administered to 229 patients (topically and orally) without a drug-related serious adverse event. With a good safety profile and promising pre-clinical efficacy, rhLF may prove to be an effective and safe new drug for wound healing. The aims of this study are to evaluate the clinical safety, pharmacokinetics and pharmacodynamics of topical rhLF in patients with diabetic ulcers. Up to 36 patients will be treated for fourteen days with escalating doses of rhLF. Safety will be evaluated clinically and by laboratory results. Incidence of partial and complete wound closure will also be observed. Safety results and any efficacy trends will be used to select rhLF doses for the proposed Phase II trial.