Telios Pharmaceutical Inc. announced Friday that it hassubmitted an amended pre-market approval application for itsArgidene gel as a treatment for diabetic foot ulcers. Thesubmission comes one month after FDA requested additionalinformation on the wound healing gel.
At the end of January, FDA told Telios of San Diego that itwanted information to show that a representative cross-sectionof the patient population with diabetic foot ulcers had beenenrolled in the Argidene trial (see BioWorld, Jan. 26). Inaddition, the agency asked the company to explain how thesafety of Argidene in patients with venous stasis or sickle-cellulcers is relevant to diabetic ulcers.
Telios (NASDAQ:TLIO) submitted the original PMA in March1993. It included data on 65 patients with diabetic foot ulcersas well as safety data from trials of Argidene use for treatmentof sickle-cell ulcers and venous stasis ulcers.
Telios said it is continuing to evaluate Argidene in threeongoing trials for diabetic foot ulcers, venous stasis ulcers andpartial thickness burns. Results of the trials are expected thisyear. -- Brenda Sandburg
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