Phase I, Open-Label, Dose-Escalating Study of a Genetically Engineered Herpes Simplex Virus, NV1020, in Subjects with Metastatic Colorectal Carcinoma to the Liver

Kemeny, Nancy E.; Brown, Karen; Covey, Anne M.; Kim, Teresa S.; Bhargava, Amit; Brody, Lynn A.; Guilfoyle, Brenda; Haag, Natasha P.; Karrasch, Matthias; Glasschroeder, Birgit; Knoll, Anette; Getrajdman, George I.; Kowal, K. Jon; Jarnagin, William R.; Fong, Yuman

doi:10.1089/hum.2006.17.ft-262

Cited by 15 publications

(19 citation statements)

References 35 publications

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“…A phase I trial of NV1020 administered by hepatic arterial infusion (HAI) was performed in HSV-seropositive patients with colorectal liver metastases. 52 No significant toxicity was noted in patients receiving doses up to 1 Â 10 8 pfu per infusion. No replication data were reported.…”

Section: Genetic Engineering Of Oncolytic Viruses Targets Cancer Signmentioning

confidence: 93%

Gene therapy progress and prospects cancer: oncolytic viruses

Liu¹,

2008

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Section: Genetic Engineering Of Oncolytic Viruses Targets Cancer Signmentioning

confidence: 93%

Gene therapy progress and prospects cancer: oncolytic viruses

Liu¹,

2008

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“…NV1020 is also an important herpes oncolytic virus that can be specifically used for intravascular injections. A doseescalation study in 2006 showed that NV1020 could be safely and feasibly injected into the hepatic artery to treat colon liver metastases, 5 and a study in 2009 reported some efficacy with NV1020. 6 However, these HSV mutants are artificially and genetically modified viruses, and some have a weak replication capacity and are easily cleared by the host immune system.…”

Section: Introductionmentioning

confidence: 99%

A phase I dose-escalation clinical trial of intraoperative direct intratumoral injection of HF10 oncolytic virus in non-resectable patients with advanced pancreatic cancer

et al. 2010

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In 2005, we initiated a clinical trial that examined the efficacy of the oncolytic virus HF10 to treat pancreatic cancer. Pancreatic cancer continues to have a high mortality rate, despite multimodal treatments for patients, and new therapeutic methods are greatly needed. The current mainstream methods for cancer treatment include biological therapeutics such as trastuzumab (Herceptin) for breast cancer or erlotinib (Tarceva) for non-small cell lung cancer. Oncolytic virus therapy is a new and promising treatment strategy for cancer. Oncolytic viruses are novel biological therapeutics for advanced cancer that appear to have a wide spectrum of anticancer activity with minimal human toxicity. To examine the efficacy of oncolytic virus therapy for pancreatic cancer, we initiated pilot studies by injecting six patients with non-resectable pancreatic cancer with three doses of HF10. All patients were monitored for 30 days for local and systemic adverse effects and were not administered any other therapeutics during this period. There were no adverse side-effects, and we observed some therapeutic potential based on tumor marker levels, survival, pathological findings and diagnostic radiography. The tumors were classified as stable disease in three patients, partial response in one patient and progressive disease in two patients.

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“…To date, Phase I and II clinical trials have been conducted with various HSV-1 mutants, showing the safety of administering various oncolytic mutants of HSV-1 in humans. [10][11][12][13] Although HSV-1 oncolytic vectors possess many properties that make this virus well suited for oncolytic virotherapy, there are a number of disadvantages with this platform. As a human pathogen, HSV-1 must be genetically manipulated to attenuate the virus sufficiently for it to preferentially replicate in tumor cells.…”

Section: Introductionmentioning

confidence: 99%

Bovine herpesvirus type 1 as a novel oncolytic virus

2009

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Oncolytic virotherapy is a promising avenue of cancer gene therapy. Current vectors include human viruses that have been engineered to replicate in tumor cells or nonhuman viruses that are naturally oncotropic and preferentially replicate in tumor cells harboring defects in innate immune pathways such as the type 1 interferon (IFN) pathway. Bovine herpesvirus type 1 (BHV-1) is a species-specific herpesvirus closely related to the human herpes simplex virus type 1 (HSV-1). Although BHV-1 does not efficiently replicate in and affect cellular viability of normal human cells, it is capable of infecting and killing various immortalized and transformed human cell types. Surprisingly, BHV-1 infection of human cells fails to elicit IFN production at the mRNA or protein level and the ability of BHV-1 to kill immortalized and transformed human cells does not correlate with defects in IFN pathways. Furthermore, although some cross-reactivity between BHV-1 and HSV-1 exists, the majority of human antibody or serum samples tested failed to neutralize BHV-1 despite possessing HSV-1 neutralizing capacity. Thus, BHV-1 is a novel candidate oncolytic virus with a distinct mechanism of tumor targeting.

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Phase I, Open-Label, Dose-Escalating Study of a Genetically Engineered Herpes Simplex Virus, NV1020, in Subjects with Metastatic Colorectal Carcinoma to the Liver

Cited by 15 publications

References 35 publications

Gene therapy progress and prospects cancer: oncolytic viruses

Gene therapy progress and prospects cancer: oncolytic viruses

A phase I dose-escalation clinical trial of intraoperative direct intratumoral injection of HF10 oncolytic virus in non-resectable patients with advanced pancreatic cancer

Bovine herpesvirus type 1 as a novel oncolytic virus

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