Synthetic Peptides Demonstrate Promise in Orthopedic Applications
BY JOHN CHOPACK, JULY 6, 2005
Fziomed, Inc. recently announced that its Oxiplex Gel demonstrated efficacy in acting as a delivery platform for a novel peptide bone growth factor being developed by the Company. The study was presented at the 12th International Meeting on Advanced Spine Techniques (IMAST) held in Banff, Alberta, Canada. The synthetic peptides in development for orthopedic applications are large chains of amino acids which enhance bone and/or cartilage growth by mimicking specific cell interactions.
Fziomed's novel peptide bone growth factor is in early development for the treatment of bone defects and fractures. The Company's preclinical results show promise but the product will most likely require clinical studies via either a New Drug Application ("NDA") or a Premarket Application ("PMA") regulatory process. This will prohibit market launch for several years.
The current leader, to our knowledge, is OrthoLogic which is completing enrollment of its Phase III fracture repair study. The Company's synthetic peptide, Chrysalin, is also in development to speed spine fusion, cartilage lesions and soft tissue injuries. Another company which is currently seeking a PMA is Cerapedics which has developed a synthetic peptide to help aid in spinal fusion.
The advantage of these synthetic peptides is that they show the promise to be as effective in growing bone and cartilage as bone morphogenetic proteins but cost approximately a third the price. Additionally, there is no potential for disease transmission with these products as compared to allograft/xenograft products. One drawback to peptides is their rapid half-life. In many applications they degrade too quickly. A delivery system is required that slows the degradation process yet does inhibit efficacy of the peptide.
