Gliatech Inc. said Tuesday that it's starting pivotal clinical trials ofits Adcon-T/N gel product to inhibit adhesions following tendon andperipheral nerve surgeries.
The separate trials will evaluate the semisynthetic carbohydratepolymeric gel in the treatment of persistent median nervecompression following carpal tunnel release and in tenolysis of thehand. The gel, applied around nerve roots at surgical sites, isdesigned to prevent scarring after surgery. The Cleveland companyalso is studying Adcon as a treatment after back surgery.
Each of the trials will be double-blind (evaluator, not physician) andrandomized, involving 200 to 300 patients at sites in the U.S., saidThomas Oesterling, Gliatech's president and CEO. One group willreceive Adcon after surgery, the other will have surgery alone.
Tenolysis surgeries are performed to free the tendon from theprevious scar that restricts tendon movement. In carpal tunnelsyndrome, the nerve that goes through the wrist gets constricted,sometime because of scarring.
The lumbar product, called Adcon-L, is expected to be taken intoU.S. pivotal studies in the second quarter, Oesterling told BioWorld.Results from a European pivotal trial of Adcon-L will be presentedin Berlin in May. Adcon-L and Adcon-T/N (tendon and nerve)already are being marketed in parts of Europe.
Oesterling said preclinical studies are under way for Adcon productsto be used in abdominal, pelvic and cardiac indications. _ JimShrine
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