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词条 GL-ONC1
释义

  1. Clinical trials

     Regional (cavity) administration  Systemic edministration 

  2. References

  3. External links

GL-ONC1 is an investigational therapeutic product consisting of the clinical grade formulation of the laboratory strain GLV-1h68, an oncolytic virus developed by Genelux Corporation.[1] GL-ONC1 is currently under evaluation in Phase I/II human clinical trials in the United States and Europe.[1]GL-ONC1 (CAS Registry Number (CAS RN): 1473430-36-2) is an attenuated vaccinia virus (Lister strain) that causes regression and elimination of a wide range of solid tumors in preclincal mouse models.[2] GLV-1h68 (GL-ONC1) was generated by insertion of three expression cassettes (encoding Renilla luciferase-Aequorea green fluorescent protein fusion, beta-galactosidase, and beta-glucuronidase) replacing the F14.5L, J2R (encoding thymidine kinase) and A56R (encoding hemagglutinin) loci of the parental viral Lister strain genome, respectively.[3] The oncolytic virus specifically infects and kills tumor cells which leads to oncolysis, which is thought to trigger an anti-tumor immune response.[4][5][6]

Clinical trials

Regional (cavity) administration

One Phase I/II Study of intraperitoneal administration of GL-ONC1 in patients with advanced peritoneal carcinomatosis has been completed.[7][8] A Phase II study of intraperitoneal administration of GL-ONC1 in patients with recurrent ovarian cancer is ongoing.[9]

In a Phase I study, intra-pleural administration of GL-ONC1 is being evaluated in patients with malignant pleural effusion, which is caused by cancer from malignant pleural mesothelioma, non-small cell lung cancer (NSCLC), or breast cancer.[10] In this trial GL-ONC1 infection of tumor cells was identified in 6 out of 8 patients with epithelioid malignant pleural mesothelioma.[11]

Systemic edministration

Systemic administration of GL-ONC1 via intravenous injection was under investigation in two different clinical trials:

In one study, GL-ONC1 was administered to patients with advanced solid organ tumors as a monotherapy.[12] In another completed study, GL-ONC1 was given in combination with radiation therapy and cisplatin (CDDP) to patients with locoregionally advanced head and neck cancer.[13]

References

1. ^{{cite web|url=https://clinicaltrials.gov/ct2/results?term=GL-ONC1&Search=Search|title=Search of: GL-ONC1 - List Results - ClinicalTrials.gov|work=clinicaltrials.gov}}
2. ^{{cite journal | vauthors = Donat U, Weibel S, Hess M, Stritzker J, Härtl B, Sturm JB, Chen NG, Gentschev I, Szalay AA | title = Preferential colonization of metastases by oncolytic vaccinia virus strain GLV-1h68 in a human PC-3 prostate cancer model in nude mice | journal = PLOS One | volume = 7 | issue = 9 | pages = e45942 | date = 2012 | pmid = 23049897 | pmc = 3457966 | doi = 10.1371/journal.pone.0045942 }}
3. ^1 {{cite journal | vauthors = Zhang Q, Yu YA, Wang E, Chen N, Danner RL, Munson PJ, Marincola FM, Szalay AA | title = Eradication of solid human breast tumors in nude mice with an intravenously injected light-emitting oncolytic vaccinia virus | journal = Cancer Research | volume = 67 | issue = 20 | pages = 10038–46 | date = October 2007 | pmid = 17942938 | doi = 10.1158/0008-5472.can-07-0146 }}
4. ^{{cite journal | vauthors = Melcher A, Parato K, Rooney CM, Bell JC | title = Thunder and lightning: immunotherapy and oncolytic viruses collide | journal = Molecular Therapy | volume = 19 | issue = 6 | pages = 1008–16 | date = June 2011 | pmid = 21505424 | pmc = 3129809 | doi = 10.1038/mt.2011.65 }}
5. ^{{cite journal | vauthors = Tong AW, Senzer N, Cerullo V, Templeton NS, Hemminki A, Nemunaitis J | title = Oncolytic viruses for induction of anti-tumor immunity | journal = Current Pharmaceutical Biotechnology | volume = 13 | issue = 9 | pages = 1750–60 | date = July 2012 | pmid = 21740355 | doi = 10.2174/138920112800958913 }}
6. ^{{cite journal | vauthors = Naik JD, Twelves CJ, Selby PJ, Vile RG, Chester JD | title = Immune recruitment and therapeutic synergy: keys to optimizing oncolytic viral therapy? | journal = Clinical Cancer Research | volume = 17 | issue = 13 | pages = 4214–24 | date = July 2011 | pmid = 21576084 | pmc = 3131422 | doi = 10.1158/1078-0432.ccr-10-2848 }}
7. ^{{ClinicalTrialsGov|NCT01443260|A Study of GL-ONC1, an Oncolytic Vaccinia Virus, in Patients With Advanced Peritoneal Carcinomatosis}}
8. ^{{cite journal | vauthors = Lauer UM, Schell M, Beil J, Berchtold S, Koppenhöfer U, Glatzle J, Königsrainer A, Möhle R, Nann D, Fend F, Pfannenberg C, Bitzer M, Malek NP | display-authors = 6 | title = Phase I study of oncolytic vaccinia virus GL-ONC1 in patients with peritoneal carcinomatosis | journal = Clinical Cancer Research | volume = | issue = | pages = | date = May 2018 | pmid = 29773661 | doi = 10.1158/1078-0432.CCR-18-0244 | url = }}
9. ^{{ClinicalTrialsGov|NCT02759588|GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent Ovarian Cancer}}
10. ^{{ClinicalTrialsGov|NCT01766739|Intra-pleural Administration of GL-ONC1, a Genetically Modified Vaccinia Virus, in Patients With Malignant Pleural Effusion: Primary, Metastases and Mesothelioma}}
11. ^{{cite journal | first1 = Lee M. | last1 = Krug | first2 = Marjorie Glass | last2 = Zauderer | first3 = Prasad S. | last3 = Adusumili | first4 = Erin | last4 = McGee | first5 = Kent | last5 = Sepkowitz | first6 = Mark | last6 = Klang | first7 = Yong A. | last7 = Yu | first8 = Paul | last8 = Scigalla | first9 = Valerie W. | last9 = Rusch | name-list-format = vanc | display-authors = 6 | journal = Journal of Clinical Oncology | volume = 33 | issue = 15_suppl | date = May 2015 | pages = 7559–7559 | title = Phase I study of intra-pleural administration of GL-ONC1, an oncolytic vaccinia virus, in patients with malignant pleural effusion | doi = 10.1200/jco.2015.33.15_suppl.7559 }}
12. ^{{ClinicalTrialsGov|NCT00794131|Safety Study of GL-ONC1, an Oncolytic Virus, in Patients With Advanced Solid Tumors}}
13. ^{{ClinicalTrialsGov|NCT01584284|Safety Study of Attenuated Vaccinia Virus (GL-ONC1) With Combination Therapy in Head & Neck Cancer}}

External links

  • Genelux website

3 : Experimental cancer treatments|Virotherapy|Oncolytic virus
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