This clinical trial is designed to assess the safety and efficacy of velafermin for the prevention of oral mucositis in cancer patients receiving high-dose chemotherapy, with or without radiotherapy, in the setting of autologous bone marrow transplantation (BMT).
The primary endpoint of the trial, which will enroll approximately 400 patients, is the incidence of severe oral mucositis following intravenous administration of 30 mcg/kg velafermin compared to placebo.
Secondary endpoints being evaluated include duration of oral mucositis, patient self-reported pain score, use of pain medications, the incidence and duration of febrile neutropenia, and use of enteral or parenteral nutrition.
“Based on the data generated in our initial phase II trial, which we believe demonstrated the activity of a single dose of velafermin, CuraGen and our investigators are very excited to begin enrolling patients in this potentially pivotal trial,” stated Dr Frank Armstrong, president and CEO of CuraGen.