CHARACTERIZATION OF FIBRIN SEALANT FORMULATIONS

MATRIX PHARMACEUTICAL, INC. IS CURRENTLY DEVELOPING A BIOLOGICALLY DERIVED SURGICAL ADHESIVE MATERIAL (SAM). THE SAM (PATENT PENDING) IS COMPRISED OF PATIENT-AUTOLOGOUS FIBRINOGEN, THROMBIN AND A FIBROUS PROTEIN. THE FORMULATION CAN BE ALTERED TO FACILITATE THE USE OF SAM IN A VARIETY OF SURGICAL INDICATIONS. NEW FORMUATIONS WILL BE PREPARED AND EVALUATED BY A SERIES OF IN VITRO PHYSICO-CHEMICAL AND CELL COMPATIBLAITY STUDIES. RESULTS WILL BE USED TO SELECT SEVERAL CANDIDATE FORMULATIONS SUITABLE FOR USE IN PLASTIC RECONSTURCTIVE SURGICAL INDICATIONS. THESE FORMULATIONS WILL THEN BE TESTED IN AN IN VITRO RODENT SKIN GRAFT HISTOPATHOLOGIC STUDY TO EVALUATE THEIR IMPACT ON GRAFT ATTACHMENT AND SURVIVAL. THE MOST COMMERCIALLY AND CLINICALLY PROMISING OF THESE FORMULATIONS WILL BE FURTHER TESTED IN TWO IN VIVO RODENT SKIN REPAIR MODELS TO EVALUATE MECHANICAL AND BIOLOGICAL PERFORMANCE OF THE SAM FORMULATIONS FOR WOUND REPAIR APPLICATIONS. UPON SUCCESSFUL COMPLETION OF PHASE I STUDY, PHASE II SUPPORT WILL BE REQUESTED TO FURTHER DEVELOP THE SAME FOR USE IN ENT, NEUROLOGY AND GENERAL SURGICAL INDICATIONS AND WILL INCLUDE BIOCHEMICAL, IMMUNOLOGICAL AND IN VIVO FEASIBILTY STUDIES PRIOR TO COMMENCING PILOT HUMAN CLINICAL TRIALS.