Dermagraft US Clinical Trial Update

Smith & Nephew Plc 21 December 1999 Letter to: Company Announcements DERMAGRAFT US CLINICAL TRIAL UPDATE Smith & Nephew plc, the global medical device company, and its joint venture partner Advanced Tissue Sciences (ATS) have announced the results of a planned interim analysis of data from the US clinical trial of Dermagraft in the treatment of diabetic foot ulcers. Dermagraft is a living human dermal skin replacement. Although overall healing rates were lower than in previous trials, a significant improvement was shown in Dermagraft's healing rate over control for ulcers with a duration of six or more weeks prior to entering the trial. However, for all patients, which include those with ulcers of more recent duration, the data does not demonstrate statistical significance at the interim stage. The results for the primary endpoint of complete healing at 12 weeks were as follows: Complete Healing Intent-to-Treat Intent-to-Treat At 12 weeks Dermagraft Control Patients with ulcers % N % N p-value > 6 weeks 28% 20/72 14% 10/71 0.035 All Patients 30% 27/90 23% 21/92 0.176 Further discussions are planned with the US Food and Drug Administration, following which Smith & Nephew and ATS will determine the forward plan for Dermagraft. Letter from: P.R. Chambers Assistant Company Secretary
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