Advanced Tissue Sciences Inc. (ATS) on Wednesday reported positiveclinical trial results of Dermagraft in the treatment of diabetic andpressure ulcers, but said it failed in an interim analysis to findsignificant differences of a single dose of Dermagraft versus the controlgroup in its venous ulcer pivotal trial.Also Wednesday, the La Jolla, Calif., company said the French HealthMinistry will help fund a pivotal clinical trial for Dermagraft in thetreatment of diabetic ulcers in France. Marie Burke, director ofcorporate communications for ATS, told BioWorld the Frenchgovernment will pay for all costs associated with the trial except thecost of the product and the monitoring of patients.The multiple-dose pilot trial for diabetic ulcers, consisting of 50patients in four dosing groups, showed the best results in the groupreceiving one dose (piece) of Dermagraft per week for eight weeks.Complete healing in patients in that group was 50 percent as comparedto 8 percent in the control group. Burke said results from the other twogroups would not be revealed.Also, cost-benefit data suggest that multiple doses of Dermagraftwould be cost-effective in that indication. Burke said a preliminary costof one dose is $375.Based on those results, ATS plans to submit a supplement to itsinvestigational device exemption to the FDA to begin a pivotal trial fordiabetic ulcers with Dermagraft, a completely human tissue-engineeredreplacement for the dermal layer of skin.Preliminary data from the pilot trial in the treatment of pressure ulcersindicated they may respond favorably to multiple doses of Dermagraft,the company said. Enrollment of 50 patients has been completed. ATSexpects further information to be available by the middle of the year.Results of an interim analysis of venous ulcer pivotal trial indicated nosignificant differences in the control group and those using a singledose of Dermagraft. The company said multiple doses for thatindication may not be cost-effective, so it does not expect to submit apremarket approval application this year. Patient follow-up and furtheranalysis will be done later this year."This does not delay our commercialization timeline for our first twoDermagraft products, which will be for diabetic ulcers and Dermagraft-TC (Dermagraft-transitional covering)," Burke said. n
-- Jim Shrine
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