2017
DOI: 10.2147/jhc.s122507
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Open-label phase II clinical trial in 75 patients with advanced hepatocellular carcinoma receiving daily dose of tableted liver cancer vaccine, hepcortespenlisimut-L

Abstract: BackgroundAn increasing number of studies is now devoted to immunotherapy of cancer. We evaluated the clinical benefit of hepcortespenlisimut-L (Hepko-V5 [formerly known as V5])—an oral therapeutic vaccine designated by the United States Food and Drug Administration (FDA) as an orphan drug for treatment of hepatocellular carcinoma (HCC). V5 was initially developed by us in 2002 to treat hepatitis B or C viral infections and liver cirrhosis.MethodsThe outcome of open-label Phase II trial of daily dose of V5 pil… Show more

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Cited by 8 publications
(7 citation statements)
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“…Besides the profound influence on the immune response, which is usually expected from cancer vaccines, we see very clear clinical benefits in terms of improved liver function and decrease in AFP levels, which we have shown to be correlated with tumor shrinkage. We have successfully used V5 since 2010 in hundreds of patients with HCC and we are confident that the outcome from this Phase III trial will be consistent with the results of the Phase II retrospective study published in 2017 [7] . In conclusion, our experience in dealing with V5 and patients with HCC receiving this simple to use immunotherapy is supported by the present observation.…”
Section: Discussionsupporting
confidence: 63%
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“…Besides the profound influence on the immune response, which is usually expected from cancer vaccines, we see very clear clinical benefits in terms of improved liver function and decrease in AFP levels, which we have shown to be correlated with tumor shrinkage. We have successfully used V5 since 2010 in hundreds of patients with HCC and we are confident that the outcome from this Phase III trial will be consistent with the results of the Phase II retrospective study published in 2017 [7] . In conclusion, our experience in dealing with V5 and patients with HCC receiving this simple to use immunotherapy is supported by the present observation.…”
Section: Discussionsupporting
confidence: 63%
“…This Phase III placebo-controlled, 1:1 randomized trial was initiated with the goal of recruiting a total of 120 patients with advanced HCC. The preliminary data from the initial batch of 30 enrolled patients are provided to evaluate whether observed results confirm the data from an earlier published Phase II open-label trial [7] . All patients were in advanced stage of HCC and unfit for standard therapy, i.e., surgical intervention, due to tumor size, its location, or multiplicity.…”
Section: Patients and Treatment Regimenmentioning
confidence: 74%
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“… 62 Also, hepcortespenlisimut-L, a drug used as a liver cancer vaccine, has proven to be safe, effective, and fast-acting against hepatocellular carcinoma following oral administration. 63 …”
Section: Oral Vaccination Preclinical Applicationsmentioning
confidence: 99%