Advanced Tissue Sciences Inc. said Tuesday its pivotaltrial of Dermagraft-TC in severe burns achievedstatistical significance in the primary endpoint, which wasto show it was at least as effective as cadaver skin.
Based on those results the company plans to submit apremarket approval (PMA) application in the first half of1996. The Dermagraft product in that application isdesigned to cover severe burn wounds beforeautografting.
The La Jolla, Calif.-based company's stock (NASDAQ:-ATIS) gained 75 cents Tuesday to close at $9.38.
Specific results of the pivotal study, which involved 65patients at 12 centers, are expected to be presented in apeer-reviewed forum next year.
"We saw statistical significance within a p value of .01,"said Marie Burke, director, corporate communications,for Advanced Tissue.
Each patient in the burn study was treated with a piece ofDermagraft and a piece of cadaver skin within the samearea of the body. Dermagraft-TC is an engineered humandermal tissue with a synthetic epidermal layer that isdesigned to help patients retain fluids and avoid infectionuntil they receive skin grafts.
Burke said one advantage of Dermagraft over cadaverskin is that it lasts longer, which would reduce thenumber of operations needed by patients. Cadaver skinfalls off after two weeks, she said, while Dermagraft hasbeen shown to last at least 40 days. Other advantagesinvolve the reduced risk of disease transmission and theshortage of cadaver skin, Burke said.
Advanced Tissue has pharmacoeconomic studies thatshow Dermagraft appears to provide a cost benefit, shesaid, adding that information will be fully available whenthe product is launched.
The FDA has said it intends to give the Dermagraft PMAan expedited review.
Advanced Tissue intends to market Dermagraft for theburn indication. Burke said 90 percent of severely burnedpatients in the U.S. are treated at about 80 centers, whichthe company said it can effectively target with a salesforce of six to eight people.
The skin-replacement product also is in blinded,controlled pivotal trials for diabetic foot ulcers in the U.S.and France, each of which involves 200 patients. Lastmonth the company reported on interim data from theU.S. trial that showed Dermagraft was meetingobjectives. Some data from the French study are expectedto be available in January, Burke said. n
-- Jim Shrine
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