HGSI Phase IIa repifermin data

In a double-blind Phase IIa study of 88 patients, Human Genome (HGSI) said that repifermin keratinocyte growth factor-2 (KGF-2) protein had comparable safety to placebo (the primary endpoint), although the compound showed no evidence of efficacy. Patients received intravenous repifermin daily for 5 days. A maximum tolerated dose was not reached in the trial. HGSI said it will evaluate final data, and then decide on how to proceed with the UC indication.

Also, in a double-blind Phase IIa study of 91 cancer patients undergoing chemotherapy conditioning prior to autologous hematopoietic stem cell transplantation, HGSI said that repifermin had comparable safety to placebo (the primary endpoint), although the compound showed no evidence of efficacy in treating chemotherapy-induced mucositis. Patients received intravenous repifermin daily for 14 days following the transplant. ...