A phase Ib clinical trial of PV701, a milk-derived protein extract, for the prevention and treatment of oral mucositis in patients undergoing high-dose BEAM chemotherapy

Abstract

Despite the best available agents to prevent mucositis, most patients receiving high-dose chemoradiotherapy regimens experience severe mucositis, and new therapies are needed. In this study, we evaluated the safety and tolerability of a milk-derived growth factor extract (PV701 mouthwash) intended to prevent oral mucositis (OM) after carmustine, etoposide, cytosine arabinoside, and melphalan (BEAM) chemotherapy. PV701 mouthwash (15 mL × 13.5 mg/mL) was administered 6 times a day for 12 days, from day -6 to day + 5, to patients with lymphoma, who were given BEAM on day -6 to day -2, with autologous stem cells infused on day 0. Dose de-escalation of PV701 was planned if dose-limiting toxicitie..