The goal of this proposed study is the development and refinement of a therapeutic composition that will reliably affect the regeneration of the soft and hard tissue in the periodontium that are lost or damaged due to periodontal disease. During the Phase I portion of this project we have identified a novel composition, platelet-derived growth factor BB (PDGF-BB) combined with dexamethasone (DEX), which exhibited therapeutic efficacy in a primate model of periodontal disease. In addition, a proprietary collagen based delivery system has been identified that provides a biocompatable delivery system for application of the PDGF-BB/DEX therapeutic composition.
The specific aims of this Phase II application are to 1) finalize the manufacturing methods for formulation the PDGF-BB/DEX combination with the collagen carrier, 2) evaluate the effect of different concentrations of PDGF-BB and Dexamethasone on in vivo efficacy, and 3) begin initial safety and toxicity studies on the proposed product in preparation for human clinical evaluation.
