Hadden J W, Verastegui E, Hadden E
IRX Therapeutics Inc., 1 Bioscience Park Drive Suite 101, Farmingdale, NY 11735, USA.
Ann N Y Acad Sci. 2007 Sep;1112:245-55. doi: 10.1196/annals.1415.032. Epub 2007 Jun 28.
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.
小鼠研究表明，胸腺肽α1（Tα1）与一种天然细胞因子混合物（IRX-2）在增加T淋巴细胞数量和反应方面具有协同作用。IRX-2的临床研究显示，淋巴细胞减少的癌症患者的T淋巴细胞数量增加，但对接受放疗的淋巴细胞减少患者的影响相对较小。目前的1期和2期研究表明，Tα1可增强IRX-2对这些淋巴细胞减少患者的疗效。7名患者每天皮下注射IRX-2（200单位IL-2等效剂量）、Tα1（1.6毫克/天）（4名患者）或IRX-2与Tα1的组合（7名患者），持续10天。在治疗开始时和第11天测量外周血淋巴细胞（T、B、NK）及其亚群（CD4、CD8）。IRX-2和Tα1几乎没有或没有显著影响。联合治疗显著增加了各种淋巴细胞群体（>350个细胞/微升）。4名随访6周的患者显示幼稚和记忆T细胞均持续增加。4名患者中有3名观察到对持续性感染的反应，未观察到明显毒性。Tα1和IRX-2协同作用可安全增加淋巴细胞减少患者的T细胞。
