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Interim results from ongoing PhaseⅢ placebo-controlled,randomized trial of hepcortespenlisimut-L for advanced hepatocellular carcinoma indication

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Hepatoma Research 2020年第1期6卷 11-18页

作者： Aldar S.Bourinbaiar Jigjidsuren Chinburen Purev Batchuluun Chogsom Munkhzaya DandiiOyungerel Dorjiin Dandii galyna a.kutsyna Hulan Tsogkhuu Marina G.Tarakanovskaya Alan A.Reid Vika Borisova Allen I.Bain Vichai Jirathitikal Immunitor Inc. VancouverBCV6K 2G8Canada National Cancer Center Ulaanbaatar 14000Mongolia National Center for Public Health Ulaanbaatar 13000Mongolia National Cancer Institute National Institutes of HealthBethesdaMD 20892USA Ekomed LLC Ulaanbaatar 13381Mongolia Immunitor China Ltd. ChaoyangBeijing 100027China

Aim:We aimed to further investigate the role of hepcortespenlisimut-L(Hepko-V5 or V5),a new oral immunotherapy developed by us,for hepatocellular carcinoma(HCC)***:The interim data from ongoing PhaseⅢplacebo-controlled,randomized trial were evaluated on the initial group of patients in advanced stage of HCC with emphasis on liver function and tumor marker alpha-fetoprotein ***,an in vitro study was undertaken to elucidate the mechanism of action of V5 by measuring with flow cytometry the expression of cytokines such as IL-2,INF-γ,and TNF-αand cell activation markers CD69 and Ki67 on CD4-and CD8-positive lymphocytes isolated from peripheral blood of healthy ***:As early as one month after treatment initiation,there was a clear improvement in alanine transaminase,aspartate transaminase,alkaline phosphatase,and bilirubin levels among HCC patients who received daily dose of V5,but not in the placebo ***,alpha-fetoprotein(AFP)levels among V5 recipients decreased,while in the ;placebo group they *** results are in line with in vitro observations indicating immune activation,as evidenced by many-fold enhancement of CD69,Ki67,and INF-γexpression and at the same time marked anti-inflammatory effect resulting in 10-fold decrease in TNF-αoutput and lack of influence on IL-2 ***:Hepcortespenlisimut-L,a tableted oral formulation derived from heat-inactivated pooled blood of patients with HCC and viral hepatitis shows beneficial clinical effect,as demonstrated by improvement in liver function and reduction of tumor marker AFP *** correlate with in vitro observations showing potent activation of the immune response and pronounced oral tolerance effect.

关键词： Hepatocellular carcinoma alpha-fetoprotein alanine transaminase aspartate transaminase IL-2 INF-γ TNF-α CD69 Ki67 CD4 CD8 T lymphocytes

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One-month immunotherapy trial in treatment-failed TB patients

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Open Journal of Immunology 2011年第2期1卷 50-55页

作者： Olga V. Arjanova Dmitry A. Butov Natalia D. Prihoda Svetlana I. Zaitzeva Larisa V. Yurchenko Nina I. Sokolenko Anna L. Stepanenko Tatyana S. Butova Elena A. Grinishina Olga A. Maksimenko Vichai Jirathitikal Aldar S. Bourinbaiar Valery M. Frolov galyna A. kutsyna 不详

reatment failed TB patients have very limited chances of survival. Open label trial of daily oral pill of V-5 Immunitor (V5) was conducted in 48 treatment-failed TB patients on palliative support consisting of isoniazid (H) and rifampicin (R). The subjects had the following forms of TB;cavitary: disseminated: MDR-TB: DR-TB: TB/HIV at 35:13:7:4:1 ratio. After 1 month 62.5% of V5-treated patients experienced negative sputum smear conversion (P 2 respectively (P < 0.0001). Two patients (4.2%) died from illicit drug- and alcohol-abuse related causes. No adverse effects or reactivation of disease due to immune intervention were seen at any time. V5 is safe and in combination with a simple two-drug regimen was highly effective as an immune adjunct to produce favorable outcome among treatment-failed and/ or drug-resistant TB patients.

关键词： Biomarker HIV Inflammation MDR-TB Mycobacterium Survival Treatment Failure Vaccine

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