ATIS's Dermagraft protocol

Advanced Tissue (ATIS) and partner Smith & Nephew (SNN) said they will modify the inclusion criteria for their ongoing pivotal trial of ATIS's Dermagraft engineered human dermis with synthetic epidermis to treat diabetic foot ulcers, and amend the statistical plan for analyzing data from the trial. The amended trial, which ATIS said was suggested by the FDA, will only enroll patients whose ulcers had existed for more than six weeks. In December 1999, an interim analysis showed no significant difference in healing at 12 weeks between Dermagraft and control groups (p=0.176) (see BioCentury, Jan. 4). However, among patients whose ulcers had existed for more than six weeks, 20 of 72 patients had healing versus 10 of 71 controls (p=0.035). ...