Telios Pharmaceuticals Inc.'s Argidene Gel reduced the surfacesize of leg ulcers in patients with sickle cell anemia but did notcompletely heal the ulcers, according to results of arandomized, placebo-controlled study of 55 patients treatedonce a week for up to 10 weeks.
The company presented data on Argidene (formerly calledTelio-Derm) at the Sixth International Symposium on WoundHealing and Wound Management in San Francisco lastweekend. George Phillips Jr. of Duke University Medical Centerreported that Argidene treatment resulted in a 50 percentreduction in surface size of leg ulcers, while placebo treatmentreduced ulcers by 23 percent.
At a briefing with reporters on Friday, Telios representativessaid the company is not pursuing the indication for use of thegel in sickle cell anemia patients. Phillips noted that 60,000people in the U.S. have sickle cell anemia and about 50 percentof patients get leg ulcers during the course of the disease.
Telios filed an Argidene pre-market approval application(PMA) with FDA in March for treatment of chronic dermalulcers associated with diabetes. The company is also conductingstudies for use of the gel in venous stasis ulcers, partial-thickness burns and wounds from skin cancer surgery. Teliosplans to file a PMA for the venous stasis indication next year.
Argidene gel is a synthetic polypeptide complexed withhyaluronic acid to form a conjugated gel in a phosphate buffer.According to Telios, the gel acts as a "scaffold" that providescell sites for attachment of cells central to the wound healingprocess, thereby promoting the closure of wounds. FDA hasclassified the gel as a Class III device.
At the symposium, Telios also presented data on a previouslyreported study of 65 patients with diabetic foot ulcers. MichaelPierschbacher, Telios senior vice president and scientificdirector, reported that 35 percent of patients receivingArgidene were completely healed, compared with 8 percent ofplacebo-treated patients.
The gel also reduced surface area of the ulcers by 72 percent,while the placebo reduced ulcer size by 30 percent. Patientswere treated twice a week for up to 10 weeks.
The company is also conducting a 100-150 patient study todetermine if Argidene improves the integrity of skin tissue andreduces the rate of ulcers reappearing. Patients with diabeticfoot ulcers will receive 20 weeks of treatment twice a weekand undergo a two-year follow-up. Telios representatives saidthe study is intended to obtain pharmacoeconomic data toqualify the drug for Medicaid reimbursement.
Telios noted that foot ulcers are chronic wounds that can stayopen for years, making patients highly susceptible to infection.Of 7 million diagnosed cases of diabetes, the company said 15percent will develop foot ulcers. Citing data from the AmericanDiabetes Association, it noted that there are more than 50,000amputations from diabetic infections; 42 percent of thesepatients have their opposite leg amputated within one to threeyears, and 50 percent die within three years.
-- Brenda Sandburg News Editor
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