title: SAMITAL®: a new botanical drug for the treatment of mucositis induced by oncological therapies.
abstract: SAMITAL(®) (Indena SpA, Milan, Italy) is a new multicomponent and multiacting botanical formulation rationally designed for the relief of oral mucositis induced by chemotherapy and/or radiotherapy in oncological patients. Each of the individual botanical constituents of SAMITAL-standardized extracts of Vaccinium myrtillus, Macleaya cordata and Echinacea angustifolia have a long history of clinical use that corroborates their safety and activity in SAMITAL. A number of pilot trials in oncological patients demonstrated that SAMITAL has good clinical efficacy and tolerability as evidenced by its significant effects in terms of reduction of mucositis, pain and a general improvement in patient quality of life. Importantly, the use of this botanical formulation had the added benefit that patients were able to complete their chemotherapy/radiotherapy regimen. Phase II trials with SAMITAL as part of an overall clinical development program are currently ongoing in Italy and are planned in the USA.
authors.affiliation: R&D Department, Indena SpA, Viale Ortles 12, Milan, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Morazzoni
authors.forename: Giovanna
authors.initials: G
authors.lastname: Petrangolini
authors.forename: Ezio
authors.initials: E
authors.lastname: Bombardelli
authors.forename: Massimo
authors.initials: M
authors.lastname: Ronchi
authors.forename: Walter
authors.initials: W
authors.lastname: Cabri
authors.forename: Antonella
authors.initials: A
authors.lastname: Riva
mesh_terms: D000818:Animals; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D002986:Clinical Trials as Topic; D006258:Head and Neck Neoplasms / Q000188:drug therapy / Q000532:radiotherapy; D006801:Humans; D052016:Mucositis / Q000139:chemically induced / Q000188:drug therapy*; D010936:Plant Extracts / Q000627:therapeutic use*; D011788:Quality of Life; D011832:Radiation Injuries / Q000188:drug therapy*
chemical_list: D000970:Antineoplastic Agents; D010936:Plant Extracts; C580632:samital