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GLIATECH BEGINS PIVOTAL EUROPEAN CLINICAL TRIAL OF PRODUCT TO INHIBIT SCAR TISSUE

 CLEVELAND, Dec. 1 ~PRNewswire~ -- Gliatech Inc. today announced that it has begun European clinical trials of its first product, ADCON-L, to inhibit unwanted, excess scarring following back surgery.
 The formation of excess scar tissue, or peridural fibrosis, is widely believed to be one of the prime causes of "failed back syndrome." This condition, which afflicts up to 40 percent of those who undergo back surgery, costs the U.S. healthcare system upwards of $3 billion annually in repeated surgeries and additional care.
 "If the human trials of ADCON-L prove successful, we expect that the product will be used prophylactically in most back surgeries," said Thomas Oesterling, Ph.D., president and chief executive officer of Gliatech. He notes that some 400,000 lower back surgeries are performed annually in the U.S. alone.
 Initial trial sites are at the Centre Hospitalier Vaudois in Lausanne, Switzerland, and Kantonspital Basel in Basel, Switzerland. Gliatech plans to expand the trials to include several other hospitals throughout Western Europe.
 The trials are designed to provide the pivotal test of ADCON-L, which will be applied in the form of a gel to patients following back surgery. Due to the nature of the intended use of ADCON-L, product safety and efficacy evaluation will be consolidated into one study.
 Preclinical tests on a variety of laboratory models have shown that ADCON-L inhibits unwanted scar tissue without adverse effect. Based on its mechanism of action, ADCON-L has been classified by the U.S. Food & Drug Administration as a medical device.
 The European studies will be performed according to a standardized protocol, the results of which will be incorporated into Gliatech's U.S. submission to the FDA for product approval. The company plans to start U.S. clinical trials in early 1993.
 ADCON-L is the first in a family of products Gliatech is developing to inhibit surgical adhesion formation. Other products under development include ones intended for abdominal, pelvic, cardiac, tendon and implant surgeries. The next ADCON product to enter clinical trials will be targeted against excess scar formation following tendon surgery. Approximately one million tendon surgeries are performed in the U.S. each year, including 450,000 hand surgeries. The total market potential for surgical adhesion prevention products in the U.S. alone is in excess of $1 billion annually.
 Gliatech was formed in 1988 discover, develop and commercialize therapeutic products based on an understanding of properties of glial cells, a major component of the nervous system.
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 ~CONTACT: Dr. Thomas O. Oesterling, president of Gliatech, 216-831-3200; or Anthony J. Russo, of Noonan~Russo Communications, Inc., 212-979-9180, for Gliatech.~


CO: Gliatech Inc. ST: Ohio IN: MTC SU:

TS-LR -- NY018 -- 2296 12~01~92 09:46 EST
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Publication:PR Newswire
Date:Nov 30, 1992
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