title: IRX-2 and thymosin alpha1 (Zadaxin) increase T lymphocytes in T lymphocytopenic mice and humans.
abstract: Mouse studies showed a synergy of thymosin alpha1 (Talpha1) 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 Talpha1 enhances the effect of IRX-2 in these lymphocytopenic patients. Patients (seven) were treated with subcutaneously injected IRX-2 (200 units IL-2 equivalence), Talpha1 (1.6 mg/day) (four patients), or the combination of IRX-2 and Talpha1 (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 Talpha1 had little or no significant effect. The combination markedly increased various lymphocyte populations (>350 cells/microL). Four patients followed for 6 weeks displayed sustained increases involving both naïve and memory T cells. Responses to persistent infections were observed in three of the four patients and no significant toxicity was observed. Talpha1 and IRX-2 synergize to increase safely T cells in lymphocytopenic patients.
authors.affiliation: IRX Therapeutics Inc., 1 Bioscience Park Drive Suite 101, Farmingdale, NY 11735, USA.
authors.forename: J W
authors.initials: JW
authors.lastname: Hadden
authors.forename: E
authors.initials: E
authors.lastname: Verastegui
authors.forename: E
authors.initials: E
authors.lastname: Hadden
mesh_terms: D000818:Animals; D015496:CD4-Positive T-Lymphocytes / Q000187:drug effects / Q000276:immunology; D018414:CD8-Positive T-Lymphocytes / Q000187:drug effects / Q000276:immunology; D016207:Cytokines / Q000494:pharmacology* / Q000627:therapeutic use*; D006801:Humans; D008231:Lymphopenia / Q000188:drug therapy* / Q000276:immunology; D051379:Mice; D013601:T-Lymphocytes / Q000187:drug effects / Q000276:immunology*; D000077596:Thymalfasin; D013947:Thymosin / Q000031:analogs & derivatives* / Q000494:pharmacology / Q000627:therapeutic use
chemical_list: D016207:Cytokines; C114857:IRX 2; D013947:Thymosin; D000077596:Thymalfasin