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Bourinbaiar et al. Hepatoma Res 2020;6:2 Hepatoma Research
DOI: 10.20517/2394-5079.2019.25

Original Article Open Access

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

Aldar S. Bourinbaiar , Jigjidsuren Chinburen , Purev Batchuluun , Chogsom Munkhzaya , Dandii
2
1
2
2
Oyungerel , Dorjiin Dandii , Galyna A. Kutsyna , Hulan Tsogkhuu , Marina G. Tarakanovskaya , Alan A.
5
5
4
3
3
Reid , Vika Borisova , Allen I. Bain , Vichai Jirathitikal 1
6
1
6
1 Immunitor Inc., Vancouver, BC, V6K 2G8, Canada.
2 National Cancer Center, Ulaanbaatar 14000, Mongolia.
3 National Center for Public Health, Ulaanbaatar 13000, Mongolia.
4 National Cancer Institute, National Institutes of Health, Bethesda, MD 20892, USA.
5 Ekomed LLC, Ulaanbaatar 13381, Mongolia.
6 Immunitor China Ltd., Chaoyang, Beijing 100027, China.
Correspondence to: Dr. Aldar Bourinbaiar, Immunitor Inc., 365-2912 West Broadway, BC, V6K 2G6, Canada.
E-mail: aldar@immunitor.com
How to cite this article: Bourinbaiar AS, Chinburen J, Batchuluun P, Munkhzaya C, Oyungerel D, Dandii D, Kutsyna GA, Tsogkhuu H,
Tarakanovskaya MG, Reid AA, Borisova V, Bain AI, Jirathitikal V. Interim results from ongoing Phase III placebo-controlled, randomized
trial of hepcortespenlisimut-L for advanced hepatocellular carcinoma indication. Hepatoma Res 2020;6:2.
http://dx.doi.org/10.20517/2394-5079.2019.25
Received: 30 Oct 2019 First Decision: 18 Nov 2019 Revised: 23 Dec 2019 Accepted: 23 Dec 2019 Published: 7 Jan 2020

Science Editor: Guang-Wen Cao Copy Editor: Jing-Wen Zhang Production Editor: Tian Zhang

Abstract
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) indication.

Methods: The interim data from ongoing Phase III placebo-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 levels.
Additionally, 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-α and cell activation markers CD69 and Ki67 on
CD4- and CD8-positive lymphocytes isolated from peripheral blood of healthy volunteers.

Results: 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 group. Additionally, alpha-fetoprotein (AFP) levels among V5 recipients decreased, while in the

© The Author(s) 2019. Open Access This article is licensed under a Creative Commons Attribution 4.0
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