IRX-2 and Thymosin ?1 (Zadaxin) Increase T Lymphocytes in T Lymphocytopenic Mice and Humans
Mouse studies showed a synergy of thymosin ?1 (T?1) and a natural cytokine mixture (IRX-2) in increasing T lymphocyte number and responses. Clinical studies with IRX-2 showed increases of T lymphocytes in lymphocytopenic cancer patients but relatively little effect on irradiated, lymphocytopenic patients. The present phase 1 and 2 study shows that T?1 enhances the effect of IRX-2 in these lymphocytopenic patients. Patients (seven) were treated with subcutaneously injected IRX-2 (200 units IL-2 equivalence), T?1 (1.6 mg/day) (four patients), or the combination of IRX-2 and T?1 (seven patients) daily for 10 days. Peripheral blood lymphocytes (T, B, NK) and subsets (CD4, CD8) were measured at the start of treatment and on day 11. IRX-2 and T?1 had little or no significant effect. The combination markedly increased various lymphocyte populations (>350 cells/?L). Four patients followed for 6 weeks displayed sustained increases involving both nave and memory T cells. Responses to persistent infections were observed in three of the four patients and no significant toxicity was observed. T?1 and IRX-2 synergize to increase safely T cells in lymphocytopenic patients
irx-2 thymosin ?1 zadaxin t lymphocytes ncm thymalfasin thymus lymphocytopenia head and neck cancer radiotherapy