Advanced Tissue Sciences Inc. (ATS) said Tuesday that it filed asupplement to its investigational device exemption seeking approval ofa pivotal trial of Dermagraft in the treatment of diabetic foot ulcers.The La Jolla, Calif., company would enroll 200 patients in up to 20clinical sites in the pivotal trial. Patients would get one piece ofDermagraft per week for eight weeks, and be followed for 24 months.Results of a multiple-dose pilot trial announced in April showedcomplete healing of 50 percent in those getting one piece ofDermagraft per week vs. 8 percent healing in the control group.The U.S. trial will run parallel to a 200-patient pivotal trial in Francethat is largely being funded by the French Health Ministry."We anticipate we will begin (U.S.) trials sometime this fall and havedata available in the third or fourth quarter of next year, and we woulduse that data to submit a PMA (product market application) with theFDA," Marie Burke, director of corporate communications for ATS,told BioWorld.Burke said data from a 50-patient pilot trial using Dermagraft in thetreatment of pressure ulcers is expected in August, at which point thecompany will decide whether to go forward with a pivotal trial. Thevenous ulcer indication is on hold after an interim analysis showed nosignificant difference between a single dose of Dermagraft and thecontrol. Multiple doses for that indication may not be cost-effective,Burke said.Dermagraft is a completely human tissue-engineered replacement forthe dermal layer of the skin. The company has preliminarily priced adose at $375, which would be about $3,000 for an eight-weektreatment. Burke said about 400,000 patients with diabetic ulcers aretreated each year in the U.S., about the same number in Europe andabout half as many in Asia.ATS (NASDAQ:ATIS) stock closed unchanged Tuesday at $4.63. _Jim Shrine
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