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July 10, 2006
Acologix reported positive results of a phase II trial of AC-100, their novel synthetic peptide to promote dentin formation, at the Annual Meeting of the International Association for Dental Research (IADR) in Brisbane, Australia. Results from the study indicated that the drug was efficacious in stimulating the formation of new dentin when applied to tooth defects at 2 months. The greatest increase in dentin thickness was observed in the deepest cavities (remaining dentin thickness <0.5 mm). No serious adverse events were reported. This randomized, double-blind, placebo-controlled study enrolled 35 patients scheduled for third-molar (wisdom tooth) extraction, who each received 200 ug AC-100 on one tooth and placebo on another applied on days 0, 2 and 4 through dentin tubules.
July 11, 2005
Isolagen announced positive results of a phase II trial of their Isolagen Process, their collagen-producing autologous fibroblast transplant therapy for the treatment of interdental papillary insufficiency. Trial data achieved statistical superiority compared to placebo in both Investigator and Subject Visual Analog Scales at 4 months, and evidence of gum-tissue growth was noted. Statistical improvements in objective linear measures, however, were not achieved, though positive trends were noted. This randomized, double-blind, placebo-controlled study, initiated in May 2004, enrolled subjects at a single US site, who were followed for 4 months following treatment with the Isolagen Process or placebo. Based on these results, the companies announced plans to initiate pivotal double blind, internal and placebo controlled phase III trials of the drug in the near future. These trials were to investigate the efficacy and safety of the drug in improving appearance of gum tissue.
February 9, 2004
Isolagen reported positive results from a phase I trial investigating their Autologous Cellular Therapy for the treatment of periodontal disease. Results showed that the treatment successfully reversed gingival recession and improved deep- periodontal pocketing. Data demonstrated 81% of the subjects treated with Isolagen showed an improvement in pocket depth compared with 33% in placebo treated area. In addition, between teeth area’s showed an improvement at 20 of 21 Isolagen treated sites, with deterioration of the gum height recorded at most placebo sites. The 6-month, double-blind study enrolled 21 subjects at the University of Texas Health Science Center (UTHSC) Dental Branch.