Gliatech Inc. announced Monday that it is initiating pilot clinicaltrials of Adcon-T for prevention of postoperative adhesionsfollowing tenolysis of hand tendons and neurolysis ofperipheral nerves. Two studies will be conducted inSwitzerland, one in patients having tenolysis surgery and onein patients having neurolysis surgery, and one trial will beconducted in France in tenolysis patients. Each trial will enroll20 patients.
Gliatech, of Cleveland, Ohio, explained that after hand tendonrepair surgery, adhesions are formed due to scarring aroundthe tendon that reduce the ability of the tendon to glide,limiting range of finger motion. In the peripheral nervoussystem, postsurgical scarring can lead to tethering andcompression of nerves.
Thomas Oesterling, president of Gliatech, told BioWorld thatafter surgery the body releases a fibroblast cell that begins theprocess of scar formation. He said Adcon, a semisyntheticcarbodhydrate polymeric gel applied before the wound isclosed, "serves as a barrier to fibroblast migration to areaswhere you do not want scarring" to occur.
Adcon-T is the second Adcon product to enter clinicals. LastNovember, Adcon-L, for use in lumbar disc surgery, enteredclinicals at seven European centers in Switzerland, Holland andBelgium. Gliatech also plans to pursue testing in the U.S. Thecompany filed an investigational device exemption (IDE) forAdcon-L and is finishing studies the FDA requested prior toinitiating clinicals. It plans to file an IDE for Adcon-T later thisyear.
There are several other Adcon products in preclinical testing,including Adcon-A for abdominal surgery; Adcon-P forpelvic/gynecological surgery; Adcon-C for cardiac surgery; andAdcon-I for implant surgery.
Other Gliatech products further behind in development arecognition modulators, which Oesterling anticipates will reachthe market in five to seven years, and drugs for the treatmentof Alzheimer's disease, 10 to 15 years away from marketing.The cognition modulators include GT-2016 receptor antagonistto enhance cognition and GT-5140 receptor agonist to decreasecognition and treat insomnia and anxiety.
-- Brenda Sandburg News Editor
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