Topical Therapy for Chronic Wounds
Chronic wounds or ulcerations of the extremities represent a major medical condition affecting millions of people. A chronic wound shows no signs of significant healing after topical/surgical treatment measures for three to six months. Non-healing wounds affect 6.5 million Americans, with an annual US healthcare burden of $25 billion. These conditions are increasing with the aging population and rising incidence of diabetes, a leading cause. Other causes of chronic ulcers are venous stasis and decubitus ulcers in immobilized patients, and complications of hemolytic anemias. Current treatments often imperfect are not lasting. Additional, or new, therapeutics to promote wound closure are needed.
Phoenicia scientists identified a drug which, when given parenterally, dramatically accelerates healing, including complete closure in refractory leg ulcers associated with hemolytic anemias (sickle cell and thalassemia leg ulcers). The intravenously-delivered drug has a favorable safety profile and is acceptable for severe populations with large affected wounds, such as burns, and in hospitalized patients. However, a topical delivery system is preferable for many patients outside a hospital. With a new STTR grant awarded in 2013, Phoenicia is now refining a topical formulation of the drug which worked intravenously. This first-in-class therapeutic offers significant benefit for the suffering and growing economic health care burden of refractory wounds.
This Program is comparing the activity of new topical preparations in animal models. Elucidating the mechanisms of action of the active agent (API) in promoting healing, e.g, effects on keratinocyte proliferation and migration, and histological analysis of healing wounds is a goal. Refining a topical formulation that heals difficult and debilitating wounds will enable a new clinical trial.
· Supported by the Office of Orphan Product Development, Food and Drug Administration
· Supported by the National Institute of General Medical Sciences