An investigator presented data Friday from a pivotal trial showingAdvanced Tissue Sciences Inc.'s Dermagraft-TC reached its primaryendpoint of preparing a wound bed for autografting and performedbetter than control in various secondary endpoints.
La Jolla, Calif.-based Advanced Tissue reported in December theachievement of statistical significance in the 66-patient study. (SeeBioWorld Today, Dec. 20, 1995, p. 1.) Specific results, however,were reported for the first time Friday at the 28th Annual Meeting ofthe American Burn Association.
Results showed Dermagraft-TC, an engineered dermal tissue,prepared the wound bed as well or better than cadaver skin, whichwas used as a control (p=0.0001). Dermagraft-TC's mean autograftrate was 94.7 percent at day 14 while the control rate was 93.1percent.
The company said Dermagraft-TC performed significantly better thancontrol (p<0.005) in the secondary endpoints of ease of removal,amount of excision at removal, bleeding at removal and investigators'overall satisfaction with the temporary covering. Also, the productwas as effective as control for other endpoints, such as adherence,wound closure and the incidence of infection.
Advanced Tissue plans to file a premarket approval (PMA)application in the first half of this year. The company also has pivotaltrials ongoing in the U.S. and France of another product, Dermagraft,for diabetic foot ulcers.
Marie Burke, the company's director, corporate communications,said French authorities will allow Advanced Tissue to end that studyon June 30, 1996, and agreed to supplement data gathered in Francewith data from the 200-patient pivotal study in the U.S. The endpointin those studies is complete wound closure.
Burke said the diabetic foot ulcers study should be completed in timefor submission of a PMA by the end of the year.
Advanced Tissue's stock (NASDAQ:ATIS) fell 75 cents Friday toclose at $13.50. n
-- Jim Shrine
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