New stimulator for chronic wound healing-Phase II

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DESCRIPTION (provided by applicant): Our society becomes increasingly vulnerable to chronic wounds as we age and become more obese. Despite that, efficient, inexpensive and simple-to-apply wound-healing drugs are presently unavailable. Here, we initiated the development of such a drug. In Phase I we demonstrated the superior wound-healing activity of a collagen-, fibroblast- and angiostimulatory compound isolated in our lab from a medicinal plant used for chronic wound treatment. The bioactivity of this compound has been validated in healing-impaired diabetic mice and in wounded human skin graft/mouse chimeras. Furthermore, the preliminary safety studies showed that the topical application of this product may be safe. In this Phase II project we propose to a) establish the optimal bioactive dose of this compound using rodent and rabbit wound-healing models; b) demonstrate in rodents, rabbits and swines that this compound is more efficient than the wound-healing prescription drug currently used in clinic; c) demonstrate that this drug- candidate not only does stimulate wound healing, but also results in greater tensile strength of the healed tissue, d) validate its safety in a series of PK/ADME/Toxicology tests. Together, the proposed experiments should confirm the therapeutic potential of this novel wound-healing compound and advance its development towards the IND application.