Organogenesis Inc. completed enrollment for a 300-patient pivotal trialof its bilayered skin product, Graftskin, for the treatment of chronicvenous ulcers.The company, of Canton, Mass., said it already received approval tomarket Graftskin in Sweden and has submitted regulatory filings inmore than 20 countries. Organogenesis said it plans to file formarketing approval with the FDA later this year.The product, which contains all the components in human skin, isplaced on the wound bed, cut to fit, covered with a film dressing andtaped in place.The trial, to be conducted at 15 centers, will compare Graftskin againsta standard therapy, "Unna's Paste Boot," which consists of zinc oxidegauze and an elastic bandage wrap for compression.Michael Sabolinski, the company's vice president of medical andregulatory affairs, told BioWorld that Unna's Boot comes with sideeffects such as pain and itching, and patients often take it off. But, hesaid, no other treatment has proved more effective."We wanted to make as compelling a showing to the FDA andscientific community as we could," Michael Pieniazek, executive vicepresident and chief financial officer for the company, told BioWorld."We're not relying on standard care in combination with our therapy,"like some other companies do, Sabolinski said. "The strongeststatement we've made is we don't have plans to conduct another studyfor this indication to gain market approval, because of the confidencewe have in this one."The company plans to present results of the venous ulcer trial at theApril 1995 Symposium on Advanced Wound care meeting in SanDiego.Organogenesis (AMEX:ORG) stock lost 13 cents Thursday, closing at$12.88 per share. _ Jim Shrine
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