HGSI reports data from lead program

Human Genome Sciences (HGSI) said that in a 94-patient Phase IIa trial, topical administration of repifermin (20 or 60 ug/cm2) twice a week for up to 12 weeks to treat chronic venous ulcers gave a significant increase in the number of patients with 75 percent wound closure at 12 weeks versus placebo (p=0.047). A total of 20 of 32 patients in the 60 ug/cm2 group had 75 percent wound closure versus 22 of 31 patients in the 20 ug/cm2 group and 14 of 31 patients in the placebo group. However, 17 patients in each repifermin group had 90 percent wound closure at 12 weeks versus 11 patients on placebo (p=0.093 for the combined repifermin data versus placebo), which was not significant. Also, 12 patients on 60 ug/cm2 repifermin had complete wound closure at 12 weeks versus 9 patients on 20 ug/cm2 repifermin and 9 patients on placebo (p=0.68 for the combined repifermin data versus placebo).

The average reduction in wound size was 73 percent in the 60 ug/cm2 group, 75 percent in the 20 ug/cm2 group and 56 percent with placebo (p=0.059). Repifermin, a keratinocyte growth factor-2 (KGF-2) protein, did achieve better wound closure in a subgroup of 65 patients with smaller venous ulcers of shorter duration. Data were presented at the World Wound Healing Congress in Melbourne. Preliminary data from the trial were previously reported (see BioCentury, May 30). ...