Chapter title |
A Phase 2, Open-Label, Randomized Study of Pexa-Vec (JX-594) Administered by Intratumoral Injection in Patients with Unresectable Primary Hepatocellular Carcinoma.
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Chapter number | 19 |
Book title |
Gene Therapy of Solid Cancers
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Published in |
Methods in molecular biology, January 2015
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DOI | 10.1007/978-1-4939-2727-2_19 |
Pubmed ID | |
Book ISBNs |
978-1-4939-2726-5, 978-1-4939-2727-2
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Authors |
Breitbach, Caroline J, Moon, Anne, Burke, James, Hwang, Tae-Ho, Kirn, David H, Caroline J. Breitbach, Anne Moon, James Burke, Tae-Ho Hwang, David H. Kirn, Breitbach, Caroline J., Kirn, David H. |
Abstract |
Primary liver cancer (hepatocellular carcinoma; HCC) in patients not eligible for surgery or transplant is currently treated by locoregional therapeutic approaches, including trans-arterial chemoembolization and radiofrequency ablation. Sorafenib (Nexavar; Bayer/Onyx) is currently the only approved systemic therapy for patients having failed locoregional interventions. Oncolytic viruses are designed to selectively replicate within, and subsequently lyse, cancer cells by a unique mechanisms-of-action that is not cross-resistant with approved therapies (Kirn et al., Nat Med 7:781-787, 2001; Parato et al., Nat Rev Cancer 5:965-976, 2005; Chiocca, Nat Rev Cancer 2:938-950, 2002; Heise and Kern, J Clin Invest 105:847-851, 2000). Given that these therapeutics are self-amplifying in tumors, the impact of dose on patient outcome is unclear. Pexa-Vec (JX-594) is an oncolytic and immunotherapeutic vaccinia virus which was shown to be well tolerated by intratumoral injection and intravenous infusions in Phase 1 trials (Park et al., Lancet Oncol 9:533-542, 2008; Breitbach et al., Nature 477:99-102, 2011). We present the design of a randomized dose-finding trial of Pexa-Vec in patients with advanced HCC in which Pexa-Vec was delivered by intratumoral injection three times every 2 weeks at one of two dose levels (1 × 10(8) plaque forming units (pfu) versus 1 × 10(9) pfu). |
X Demographics
Geographical breakdown
Country | Count | As % |
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France | 1 | 33% |
Canada | 1 | 33% |
Unknown | 1 | 33% |
Demographic breakdown
Type | Count | As % |
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Members of the public | 3 | 100% |
Mendeley readers
Geographical breakdown
Country | Count | As % |
---|---|---|
Unknown | 66 | 100% |
Demographic breakdown
Readers by professional status | Count | As % |
---|---|---|
Student > Bachelor | 9 | 14% |
Researcher | 8 | 12% |
Student > Ph. D. Student | 8 | 12% |
Student > Master | 7 | 11% |
Other | 5 | 8% |
Other | 13 | 20% |
Unknown | 16 | 24% |
Readers by discipline | Count | As % |
---|---|---|
Medicine and Dentistry | 18 | 27% |
Biochemistry, Genetics and Molecular Biology | 12 | 18% |
Agricultural and Biological Sciences | 8 | 12% |
Immunology and Microbiology | 4 | 6% |
Unspecified | 3 | 5% |
Other | 4 | 6% |
Unknown | 17 | 26% |