Repifermin: Phase IIa

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. Patients received intravenous repifermin daily for 14 days following the transplant.

According to HGSI, the repifermin dosing schedule used in the trial is no longer believed optimal, and dosing the product prior to chemotherapy is supported by preclinical studies. HGSI also said there was high variability in tumor types and patients’ chemotherapy conditioning regimens, and that fewer than expected placebo patients experienced severe mucositis. ...