Patients with chronic skin ulcers treated with Celtrix PharmaceuticalsInc.'s BetaKine investigational growth factor therapy showed "significantclinical response" in initial clinical trials, the company reported Mondayat a wound healing workshop at the National Institutes of Health in Bethesda,Md.
"Venous stasis ulcers are often resistant to a variety of therapies,including growth factors," said clinical instigator Martin Robson of theUniversity of Texas Medical Branch in Galveston. "However, when we treatedthis class of non-healing dermal ulcers with TGF-beta-2, developed by theSanta Clara, Calif., company (HASDAQ:CTRX). For treating skin ulcers, it'scontained in a collagen-based matrix, which is inserted into the ulcerto deliver therapy at the wound site and to provide a scaffold for newtissue regeneration.
The initial Phase I/II study, conducted by Robson, involved 16 patients;eight received the collagen matrix with BetaKine, eight without.
"There was a tenfold increase in the healing rate of the ulcers treatedwith BetaKine as compared to the placebo control," the company said. Celtrixhas since expanded its Phase I/II testing to "a more aggressive treatmentschedule," said Bruce Pharriss, chief executive officer. -- JenniferVan Brunt