Delivery System for Periodontal Tissue Growth Factors

Period of Performance: 04/01/1997 - 12/31/1998

Unknown

Phase 2 SBIR

Recipient Firm

Atrix Laboratories, Inc.
Fort Collins, CO 80525
Principal Investigator

Abstract

The objective of this research is to establish a biodegradable barrier membrane with controlled delivery of periodontal tissue growth factors for use in guided tissue regeneration (GTR) procedures. Barrier membranes preformed in medical kits from formulations consisting of growth factors incorporated into biodegradable polymers dissolved in biocompatible solvents will be applied to a periodontal defect where the barrier membrane will function to block epithelial growth and release growth factors to stimulate periodontal tissue regeneration. Research completed to date has shown the feasibility of releasing bioactive growth factors from the polymeric delivery system and has demonstrated the efficacy of barrier membranes formed from the polymer system to regenerate periodontal tissue in dogs. In Phase II, sterilized polymer formulations will be evaluated in vitro for their potential to produce an acceptable barrier membrane and release a combination of platelet- derived growth factor and insulin-like growth factor. The most promising formulations will then be screened in a pilot study in dogs for clinical handling properties, release kinetics, and bioactivity of released growth factors. The optimal formulation will be evaluated for clinical efficacy in the treatment of naturally occurring Class Ill periodontal defects in dogs. PROPOSED COMMERCIAL APPLICATION: There is a clinically unmet need for a therapeutic product for the predictable regeneration of periodontal tissues. A biodegradable barrier membrane that could deliver growth factors to accelerate periodontal tissue regeneration would provide significant clinical advantages in a market estimated at $100 million per year. It is anticipated that such a product could also be used in other dental applications such as implants and ridge reconstruction, and in orthopedic applications as well.