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Review of pediatric use

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[http://www.nbglobe.com/2010/11/19/status-on-oncolytic-virus-therapies-for-pediatric-solid-tumors/ Status on oncolytic virus therapies for pediatric solid tumors - A review of a new therapy for neuroblastoma] summarises history, adult work and current pediatric trials. Can we use this source (it gives references) in the article even though it seems to be a blog ? Rod57 (talk) 20:58, 25 November 2010 (UTC)[reply]

Should be alright for uncontroversial information. They seemed to have sourced most of the info from this 2010 review. It would be better to cite that, although don't take the blogs word for it (drop me a line on my talk page if you can't access it). Also a quick NCBI search turned up this which is free and may also be useful. AIRcorn (talk) 04:45, 26 November 2010 (UTC)[reply]

JX-954 and/or JX-594

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JX-954 and/or JX-594? 99.190.82.45 (talk) 02:11, 5 September 2011 (UTC)[reply]

JX-594 is now mentioned under clinical research/Phase II. - Rod57 (talk) 02:46, 5 February 2016 (UTC)[reply]

Intro needs updating now T-VEC is approved

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also where T-VEC is mentioned in the new section on Approved agents - detail is out of date - Rod57 (talk) 02:20, 5 February 2016 (UTC)[reply]

The automatic contents list is not showing subsections

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Are subsections suppressed somewhere - it would be useful to show them. - Rod57 (talk) 02:45, 5 February 2016 (UTC)[reply]

Section "reporting" on clinical trials

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The section below seems entirely built by people going into clinicaltrials.gov and "reporting" on what is there.

This is not what we do in WP. Somebody can do this on their blog perhaps... The "lead" sentence is ridiculous in talking about the period from 2014-2018 and having a ref from 2016 (actually accepted in Nov 2015)

The more specific section below the table, is also done in the spirit of trying to provide "news" with language about some trial "ongoing" or "has started", all with no dates. One big WP:RELTIME ball of confusion. A bunch of raw spam "sources" as well. None of this is appropriate to the mission, as it is written.

Clinical research==

In 2014-2018 period a number of clinical trials were initiated for a wide range of oncolytic virus products, reflecting the ongoing clinical development of this class of therapy.[1]

Agent Indication Phase Status Route Notes Ref
Ad5-yCD/mutTKSR39rep-hIL12 Prostate carcinoma I Recruiting Intraprostatic As single agent NCT02555397
Cavatak™ Bladder carcinoma I Recruiting Intravesical Optionally combined with low-dose mitomycin C NCT02316171
Melanoma I Recruiting Intratumoral Combined with ipilimumab NCT02307149
Combined with pembrolizumab NCT02565992
CG0070 Bladder carcinoma II No longer available Intravesical As single agent NCT02143804
Recruiting Intravesical As single agent NCT02365818
DNX-2401 Brain tumors I Recruiting Intratumoral Combined with IFNγ NCT02197169
G207 Brain tumors I Not yet recruiting Intratumoral Optionally combined with radiation therapy NCT02457845
GL-ONC1 Ovarian cancer II Recruiting Intraperitoneal As single agent NCT02759588
HF10 Melanoma II Recruiting Intratumoral Combined with ipilimumab NCT02272855
Solid tumors I Recruiting Intratumoral As single agent NCT02428036
Imlygic® Hepatocellular carcinoma I Not yet recruiting Intratumoral As single agent NCT02509507
Melanoma n.a. Enrolling by invitation Intratumoral As single agent NCT02173171
II Recruiting Intratumoral As single agent NCT02366195
Combined with surgery NCT02211131
III Active, not recruiting Intratumoral Combined with pembrolizumab NCT02263508
Available Intratumoral As single agent NCT02147951
NCT02297529
Soft tissue sarcoma I/II Recruiting Intratumoral Combined with radiotherapy NCT02453191
JX-594 Hepatocellular carcinoma III Recruiting Intratumoral and Intraveinously Combined with sorafenib NCT02562755
Solid Tumors II Recruiting Intratumoral and intraveinously Combined with metronomic cyclophosphamide NCT02630368
Renal Cell Carcinoma 2L I Recruiting Intratumoral and intraveinously Combined with REGN2810
Colorectal Cancer 2L/3L I Recruiting Intratumoral and intraveinously Combined with PD-L1 and CTLA4
Liver Cancer I Recruiting Intratumoral and intraveinously Combined with Nivolumab NCT03071094
Solid Tumors I Recruiting Intratumoral and intraveinously Combined with Ipilimumab NCT02977156
Solid Tumors(neoadjuvant) I Recruiting Intratumoral and intraveinously Monotherapy
Liver Cancer I Recruiting Intratumoral and intraveinously Combined with PD-L1
MG1-MA3 Solid tumors I/II Recruiting Intravenous Combined with a MAGEA3-encoding adenovirus NCT02285816
MV-NIS Gynecological tumors II Recruiting Intraperitoneal As single agent NCT02364713
Multiple myeloma II Recruiting Intravenous Combined with cyclophosphamide NCT02192775
OBP-301 Solid tumors I Not yet recruiting Intratumoral As single agent NCT02293850
Reolysin Brain tumors I Recruiting Intravenous Combined with GM-CSF s.c. NCT02444546
Multiple myeloma I Recruiting Intravenous Combined with dexamethasone plus a proteasomal inhibitor NCT02101944
NCT02514382
Toca 511 Brain tumors II/III Not yet recruiting Intratumoral Combined with 5-FC and standard chemotherapy NCT02414165
Solid tumors I/II Recruiting Intratumoral Intravenous Combined with 5-FC NCT02576665
LOAd703 Pancreatic cancer I/IIa Recruiting Intratumoral Combined with standard of care treatment (gemcitabine plus nab-paclitaxel) NCT02705196

Abbreviations: 5-FC, 5-fluorocytosine; GM-CSF, granulocyte macrophage colony-stimulating factor; IFNγ, interferon γ; MAGEA3, melanoma antigen family A3; s.c., sub cutem.*initiated between 2014, March 1 and 2015, October 31.

Approved somewhere

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  • Talimogene laherparepvec was approved by the US FDA in 2015, with the brand name Imlygic, for the treatment of melanoma in patients with inoperable tumors.[2] In Jan 2016 it was approved in Europe for some inoperable melanoma.[3]
  • Oncorine, by Shanghai Sunway Biotech, was approved in China for Head and neck cancer in 2005.[4] It is based on the adenovirus H101.
  • RIGVIR, approved for melanoma treatment in Latvia (2004), then suspended 2019, Georgia (2015) and Armenia (2016) for melanoma treatment.


RIGVIR section needs updates

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Article still lists Rigvir as approved somewhere, but its licence has been suspended in 2019 and in Latvian media there is talk of a criminal offence having been commited. Please see original ECHO-7 article for latest news: [5]KC LV (talk) 08:18, 12 July 2019 (UTC)[reply]

Started phase III

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  • JX-594, by SillaJen, is currently in phase III for Hepatocellular Carcinoma.[6] Pexastimogene Devacirepvec(Pexa Vec) is a vaccinia virus based oncolytic immunotherapy designed to stimulate the immune system following infection and replication within tumor cells. JX-594 is a thymidine kinase-deleted Vaccinia virus plus GM-CSF.[7]
  • Reolysin, by Oncolytics Biotech, is in phase III for head and neck cancer.[8] An interim data release showed that this phase III had already obtained statistically significant tumor shrinkage in patients at their 6-week scan,[9] although the trial will not be complete until the overall survival data matures. Encouraging early results in colorectal cancer.[10][11] In total there are 31 clinical studies either completed or ongoing, including many testing Reolysin alongside standard chemotherapies in a variety of solid cancers.[12]

Started phase II

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  • JX-594, by SillaJen, is currently in phase II for Solid Tumors.[13] JX-594 is a thymidine kinase-deleted Vaccinia virus plus GM-CSF.[14]
  • GL-ONC1, a modified vaccinia virus by Genelux Corporation, is in a Phase II study of intraperitoneal administration in patients with recurrent ovarian cancer.[15] It is also in a Phase Ib study, administered intravenously for solid tumours.[16] Additional trials are ongoing utilizing alternative methods of administration including intrapleural administration for patients with malignant pleural effusion,[17] intraperitoneal injection for patients with advanced peritoneal carcinomatosis,[18] and intravenous injection in combination therapy in head and neck cancers.[19][20]
  • Seneca Valley virus (NTX-010) and (SVV-001), oncolytic picornavirus, is in phase II for small cell lung cancer and neuroblastoma.[21][4][22][23]
  • ColoAd1 was developed by Psioxus Therapeutics Ltd using the process of directed evolution. ColoAd1 has successfully completed recruitment in a Phase I clinical trials of ColoAd1.[24] The trial involved recruiting patients with metastatic solid tumours where no standard treatment options were applicable. Samples from these patients showed evidence of virus replication within tumour sites after intravenous delivery. The second phase of the ColoAd1 study is planned to commence in 2014 and will examine efficacy in patients with metastatic colorectal cancer. Unlike many other oncolytic viruses, ColoAd1 can be administered by intravenous injection rather than requiring intra-tumoral injection. A second trial is comparing the efficacy of the intravenous approach versus direct intra-tumoural injection to assess the most effective method of delivering ColoAd1 to cancer patients (see the EU Clinical Trials Register for further details). A third trial is examining the intra-peritoneal route of delivery for women with late stage ovarian cancer.
  • Cavatak[25][26] is a coxsackie virus which is in phase II clinical trials for the treatment of malignant melanoma.[27]
  • ONCOS-102 is an engineered human serotype 5/3 adenovirus coding for human GM-CSF optimized to induce systemic anti-tumor T cell response in cancer patients. It has started a phase II trial for Unresectable Malignant Pleural Mesothelioma.[28] It has completed a phase I trial and is starting another for malignant pleural mesothelioma (MPM).[29]

Started phase I

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  • SEPREHVIR (HSV-1716), by Virttu Biologics completed phase I in glioblastoma, in squamous cell carcinoma of head and neck, and in melanoma. Ongoing phase I dose escalation study of intratumoral HSV-1716 in pediatric/young adult patients with non–central nervous system solid tumours and a new phase I/IIa study in mesothelioma commenced in 2012.[30][31]
  • CGTG-102 (Ad5/3-D24-GMCSF), by Oncos Therapeutics,[32] while in phase I was already used to treat 200 advanced cancer patients in the company's Advanced Therapy Access Program.[33]
  • MV-NIS, an engineered measles virus has shown to be effective in targeted destruction of myeloma plasma cells. Radioactive Iodine imaging provides a novel technique for NIS gene expression monitoring.[34]
  • DNX-2401 is an oncolytic adenovirus with US Orphan drug status for glioma.[35]

References

  1. ^ Pol J, Buqué A, Aranda F, Bloy N, Cremer I, Eggermont A, Erbs P, Fucikova J, Galon J, Limacher JM, Preville X, Sautès-Fridman C, Spisek R, Zitvogel L, Kroemer G, Galluzzi L (February 2016). "Trial Watch-Oncolytic viruses and cancer therapy". Oncoimmunology. 5 (2): e1117740. doi:10.1080/2162402X.2015.1117740. PMC 4801444. PMID 27057469.
  2. ^ Cite error: The named reference Reuters was invoked but never defined (see the help page).
  3. ^ Metastatic Melanoma Therapy, Imlygic, Now Available in EU
  4. ^ a b Schmidt C (April 2011). "Amgen spikes interest in live virus vaccines for hard-to-treat cancers". Nature Biotechnology. 29 (4): 295–6. doi:10.1038/nbt0411-295. PMID 21478830.
  5. ^ https://en.wikipedia.org/wiki/ECHO-7
  6. ^ Clinical trial number NCT02562755 for "Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone (PHOCUS)" at ClinicalTrials.gov
  7. ^ Clinical trial number NCT02562755 for "Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone (PHOCUS)" at ClinicalTrials.gov
  8. ^ "Intravenous Administration of REOLYSIN in Combination with Paclitaxel and Carboplatin for Patients with Platinum-Refractory Head and Neck Cancers". Retrieved 31 May 2013.
  9. ^ "Positive Top Line REOLYSIN Data for First Endpoint in Randomized Phase III Study in Head and Neck Cancers". Oncolytics Biotech Inc. Archived from the original on 4 November 2013. {{cite web}}: Unknown parameter |dead-url= ignored (|url-status= suggested) (help)
  10. ^ "Oncolytics Biotech® announces positive data from translational clinical trial investigating REOLYSIN® in Patients with Metastatic Colorectal Cancer" (Press release). Biofind. 21 April 2011. Archived from the original on 25 August 2011. Retrieved 7 August 2011. {{cite press release}}: Unknown parameter |deadurl= ignored (|url-status= suggested) (help)
  11. ^ Adair RA, Roulstone V, Scott KJ, Morgan R, Nuovo GJ, Fuller M, Beirne D, West EJ, Jennings VA, Rose A, Kyula J, Fraser S, Dave R, Anthoney DA, Merrick A, Prestwich R, Aldouri A, Donnelly O, Pandha H, Coffey M, Selby P, Vile R, Toogood G, Harrington K, Melcher AA (June 2012). "Cell carriage, delivery, and selective replication of an oncolytic virus in tumor in patients". Science Translational Medicine. 4 (138): 138ra77. doi:10.1126/scitranslmed.3003578. PMC 3893925. PMID 22700953., cited in "Oncolytics Biotech® Inc. Announces Publication of Translational Clinical Trial Results in Science Translational Medicine" (Press release). Biofind. 13 June 2012. Retrieved 16 June 2012.
  12. ^ Reolysin Clinical Trials at NIH
  13. ^ Clinical trial number NCT02630368 for "A Study of Metronomic CP and JX-594 in Patients With Advanced Breast Cancer and Advanced Soft-tissue Sarcoma (METROmaJX) (METROmaJX) (TRAVERSE)" at ClinicalTrials.gov
  14. ^ Clinical trial number NCT02630368 for "A Study of Metronomic CP and JX-594 in Patients With Advanced Breast Cancer and Advanced Soft-tissue Sarcoma (METROmaJX) (METROmaJX)" at ClinicalTrials.gov
  15. ^ Clinical trial number NCT02759588 for "GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent Ovarian Cancer" at ClinicalTrials.gov
  16. ^ Clinical trial number NCT00794131 for "Safety Study of GL-ONC1, an Oncolytic Virus, in Patients With Advanced Solid Tumors" at ClinicalTrials.gov
  17. ^ Clinical trial number NCT01766739 for "Intra-pleural Administration of GL-ONC1, a Genetically Modified Vaccinia Virus, in Patients With Malignant Pleural Effusion: Primary, Metastases and Mesothelioma" at ClinicalTrials.gov
  18. ^ Clinical trial number NCT01443260 for "A Study of GL-ONC1, an Oncolytic Vaccinia Virus, in Patients With Advanced Peritoneal Carcinomatosis" at ClinicalTrials.gov
  19. ^ Clinical trial number NCT01584284 for "Safety Study of Attenuated Vaccinia Virus (GL-ONC1)With Combination Therapy in Head & Neck Cancer" at ClinicalTrials.gov
  20. ^ Mell LK, Brumund KT, Daniels GA, Advani SJ, Zakeri K, Wright ME, Onyeama SJ, Weisman RA, Sanghvi PR, Martin PJ, Szalay AA (October 2017). "Phase I Trial of Intravenous Oncolytic Vaccinia Virus (GL-ONC1) with Cisplatin and Radiotherapy in Patients with Locoregionally Advanced Head and Neck Carcinoma". Clinical Cancer Research. 23 (19): 5696–5702. doi:10.1158/1078-0432.CCR-16-3232. PMID 28679776.
  21. ^ Cite error: The named reference Rudin2014 was invoked but never defined (see the help page).
  22. ^ Clinical trial number NCT01048892 for "Seneca Valley Virus-001 and Cyclophosphamide in Treating Young Patients With Relapsed or Refractory Neuroblastoma, Rhabdomyosarcoma, or Rare Tumors With Neuroendocrine Features" at ClinicalTrials.gov, October 2012
  23. ^ Clinical trial number NCT01017601 for "Seneca Valley Virus-001 After Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer" at ClinicalTrials.gov
  24. ^ Bilsland AE, Spiliopoulou P, Evans TR (2016). "Virotherapy: cancer gene therapy at last?". F1000Research. 5. doi:10.12688/f1000research.8211.1. PMC 5007754. PMID 27635234.{{cite journal}}: CS1 maint: unflagged free DOI (link)
  25. ^ Shafren D, Davies B, Chan E, Yuan M, Green E, Stewart J, Au G (June 2011). "Oncolytic activity of Coxsackievirus A21 (CAVATAK™) in human pancreatic cancer" (PDF). poster.
  26. ^ Clinical trial number NCT00832559 for "A Study of the Intratumoural Administration of CAVATAK to Head and Neck Cancer Patients" at ClinicalTrials.gov
  27. ^ Clinical trial number NCT01227551 for "A Study of Intratumoral CAVATAK in Patients With Stage IIIc and Stage IV Malignant Melanoma" at ClinicalTrials.gov
  28. ^ Clinical trial number NCT02879669 for "A Randomised Phase II Open-label Study With a Phase Ib Safety lead-in Cohort of ONCOS-102, an Immune-priming GM-CSF Coding Oncolytic Adenovirus, and Pemetrexed/Cisplatin in Patients With Unresectable Malignant Pleural Mesothelioma " at ClinicalTrials.gov
  29. ^ "Targovax recruits the first patient in a trial with the oncolytic virus ONCOS-102 in malignant pleural mesothelioma". GlobeNewswire. Archived from the original on 2 July 2016. {{cite web}}: Unknown parameter |dead-url= ignored (|url-status= suggested) (help)
  30. ^ "Seprehvir". Virttu Biologics.
  31. ^ "Oncolytic Virus Specialist Virttu Biologics Initiates Phase I/II SEPREHVIR™ Study in Mesothelioma". BioSpace. 11 September 2012.
  32. ^ "Oncos.net".
  33. ^ "Oncolytic viruses mediating anti-tumor immunity in human cancer patients" (Press release). Oncos Therapeutics. 19 May 2010.
  34. ^ Russell SJ, Federspiel MJ, Peng KW, Tong C, Dingli D, Morice WG, Lowe V, O'Connor MK, Kyle RA, Leung N, Buadi FK, Rajkumar SV, Gertz MA, Lacy MQ, Dispenzieri A (July 2014). "Remission of disseminated cancer after systemic oncolytic virotherapy". Mayo Clinic Proceedings. 89 (7): 926–33. doi:10.1016/j.mayocp.2014.04.003. PMC 4225126. PMID 24835528.
  35. ^ "DNAtrix's Oncolytic Immunotherapy, DNX-2401, Awarded EU Orphan Medicine Designation for Treating Malignant Brain Tumors". Cision PR News Wire. 9 February 2016.

-- Jytdog (talk) 20:41, 15 June 2018 (UTC)[reply]

Rigvir

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Is the assessment here unbiased? The negative material appears based on a blog and news sources but a 2018 review in the European Journal of Pharmacology appears cautiously positive.[1] Espresso Addict (talk) 03:46, 16 April 2019 (UTC)[reply]

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