Some plant sugar binding proteins (lectins) may promote epithelial growth and repair due to effects on cell mitosis. ATL-104 is a recombinant form of a plant that is manufactured in Pichia pastoris, a yeast. ATL-104 is formulated as a mouthwash and has been evaluated in the management of mucositis.
Hunter, A., Mahendra, P., Wilson, K., Fields, P., Cook, G., Peniket, A., … Marcus, R. (2009). Treatment of oral mucositis after peripheral blood SCT with ATL-104 mouthwash: Results from a randomized, double-blind, placebo-controlled trial. Bone Marrow Transplantation, 43, 563–569.
To assess the tolerability of three ATL-104 doses and to assess the efficacy and safety of ATL-104 on mucositis in patients requiring high-dose melphalan or BEAM (carmustine, etoposide, cytarabine, and melphalan) before peripheral blood SCT (PBSCT)
This study included two parts. In the first part, patients were randomized to receive placebo or ATL-104 in doses of 50, 100, or 150 mg orally by mouthwash as a 15 mL total volume swilled in the mouth for 15-30 seconds and then swallowed. ATL-104 is a plant lectin associated with mitogenic activity and epithelial cell growth. Following harvest of PBSCs, patients received study treatment for three days before beginning a course of chemotherapy. For patients receiving BEAM, chemotherapy lasted for six days, whereas patients receiving high-dose melphalan had one day of treatment. PBSCT was administered 1–2 days after completion of chemotherapy, and patients then received three once daily doses of ATL-104. In the second part, patients were randomized to placebo or to one of the three ATL-104 doses.
The study was conducted in an inpatient setting in the United Kingdom.
Treatment with ATL-104 substantially reduced the median duration of severe oral mucositis compared with placebo (median duration: ATL-104 for two to three days, placebo 10.5 days) (p < 0.001). The effect of ATL-104 on the incidence of severe oral mucositis was inconclusive. Adverse events (AEs) were mild to moderate in intensity with gastrointestinal (GI) AEs being most common.
ALT-104 substantially reduced the duration of severe mucositis and was well tolerated.
This study had inconclusive results regarding the incidence of severe mucositis. Further studies with a larger number of patients are needed to establish the effects of ATL-104 on the duration and severity of mucositis. Limited range of ATL-104 doses may be responsible for the lack of dose-response.
Mouthwashes are easy to administer; however, adherence is a concern when used preventatively or when the patient has oral discomfort or fatigue. The hospital setting allows for easier monitoring and assistance in promoting adherence. If further studies show a benefit to patients, cost and availability will be influencing factors toward good outcomes.