Immunostimulants: clinical evaluation in non-cancer patients

Immunostimulants have large potentialities but their clinical evaluation and development are still in infancy. The appropriate time to start clinical studies is not always easy to determine: when some knowledge is available on the targets of the molecule and on assays demonstrating some immunological effects, but before a full elucidation of the precise mechanism of action. The clinical fields in which an immunomodulator can be analyzed are very large: immunodeficiencies, infectious diseases, auto-immune conditions, allergic diseases etc., provided that there is a target cell able to respond to the compound. Well-controlled, double-blind investigations are necessary, using objective clinical criteria and precise laboratory tests. Adverse effects, including bone marrow lesions or auto-immune manifestations, should be carefully looked for. The presently described strategy will probably be modified with progresses in this new discipline. A precise methodology for clinical evaluation will hopefully contribute to the development of more and more potent immunomodulators with a clearly defined activity in human diseases.