Talk:Oncolytic virus
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Review of pediatric use
edit[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)
- 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)
JX-954 and/or JX-594
editJX-954 and/or JX-594? 99.190.82.45 (talk) 02:11, 5 September 2011 (UTC)
- JX-594 is now mentioned under clinical research/Phase II. - Rod57 (talk) 02:46, 5 February 2016 (UTC)
Intro needs updating now T-VEC is approved
editalso where T-VEC is mentioned in the new section on Approved agents - detail is out of date - Rod57 (talk) 02:20, 5 February 2016 (UTC)
The automatic contents list is not showing subsections
editAre subsections suppressed somewhere - it would be useful to show them. - Rod57 (talk) 02:45, 5 February 2016 (UTC)
Section "reporting" on clinical trials
editThe 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
edit- 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
editArticle 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)
Started phase III
edit- 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
edit- 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
edit- 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
- ^ 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.
- ^ Cite error: The named reference
Reuters
was invoked but never defined (see the help page). - ^ Metastatic Melanoma Therapy, Imlygic, Now Available in EU
- ^ 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.
- ^ https://en.wiki.x.io/wiki/ECHO-7
- ^ Clinical trial number NCT02562755 for "Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone (PHOCUS)" at ClinicalTrials.gov
- ^ Clinical trial number NCT02562755 for "Hepatocellular Carcinoma Study Comparing Vaccinia Virus Based Immunotherapy Plus Sorafenib vs Sorafenib Alone (PHOCUS)" at ClinicalTrials.gov
- ^ "Intravenous Administration of REOLYSIN in Combination with Paclitaxel and Carboplatin for Patients with Platinum-Refractory Head and Neck Cancers". Retrieved 31 May 2013.
- ^ "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) - ^ "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) - ^ 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.
- ^ Reolysin Clinical Trials at NIH
- ^ 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
- ^ 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
- ^ Clinical trial number NCT02759588 for "GL-ONC1 Oncolytic Immunotherapy in Patients With Recurrent Ovarian Cancer" at ClinicalTrials.gov
- ^ Clinical trial number NCT00794131 for "Safety Study of GL-ONC1, an Oncolytic Virus, in Patients With Advanced Solid Tumors" at ClinicalTrials.gov
- ^ 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
- ^ Clinical trial number NCT01443260 for "A Study of GL-ONC1, an Oncolytic Vaccinia Virus, in Patients With Advanced Peritoneal Carcinomatosis" at ClinicalTrials.gov
- ^ Clinical trial number NCT01584284 for "Safety Study of Attenuated Vaccinia Virus (GL-ONC1)With Combination Therapy in Head & Neck Cancer" at ClinicalTrials.gov
- ^ 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.
- ^ Cite error: The named reference
Rudin2014
was invoked but never defined (see the help page). - ^ 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
- ^ Clinical trial number NCT01017601 for "Seneca Valley Virus-001 After Chemotherapy in Treating Patients With Extensive-Stage Small Cell Lung Cancer" at ClinicalTrials.gov
- ^ 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) - ^ 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.
- ^ Clinical trial number NCT00832559 for "A Study of the Intratumoural Administration of CAVATAK to Head and Neck Cancer Patients" at ClinicalTrials.gov
- ^ Clinical trial number NCT01227551 for "A Study of Intratumoral CAVATAK in Patients With Stage IIIc and Stage IV Malignant Melanoma" at ClinicalTrials.gov
- ^ 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
- ^ "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) - ^ "Seprehvir". Virttu Biologics.
- ^ "Oncolytic Virus Specialist Virttu Biologics Initiates Phase I/II SEPREHVIR™ Study in Mesothelioma". BioSpace. 11 September 2012.
- ^ "Oncos.net".
- ^ "Oncolytic viruses mediating anti-tumor immunity in human cancer patients" (Press release). Oncos Therapeutics. 19 May 2010.
- ^ 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.
- ^ "DNAtrix's Oncolytic Immunotherapy, DNX-2401, Awarded EU Orphan Medicine Designation for Treating Malignant Brain Tumors". Cision PR News Wire. 9 February 2016.
Rigvir
editIs 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)