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more information and references about patents
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new information about EMA registration
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{{medref|date=August 2014}}
{{medref|date=August 2014}}
'''RIGVIR''' ('''Riga virus''') is a [[virotherapy]] medication approved by the [[Government institutions in Latvia#Ministry of Health|State Agency of Medicines of the Republic of Latvia]].<ref name=Chumakov2012>For a freely accessible English version see page 642 of {{cite journal|vauthors=Chumakov PM, Morozova VV, Babkin IV, Baikov IK, Netesov SV, Tikunova NV | title=Oncolytic enteroviruses | journal=Molecular Biology | year= 2012 | volume= 46 | issue= 5 | pages= 639–50 | pmid= | doi=10.1134/S0026893312050032 | pmc= |url=http://www.virotherapy.eu/publications/preclinical/oncolytic-enteroviruses-2012.pdf}}<br/>
'''RIGVIR''' ('''Riga virus''') is a [[virotherapy]] medication approved by the [[Government institutions in Latvia#Ministry of Health|State Agency of Medicines of the Republic of Latvia]].<ref name=Chumakov2012>For a freely accessible English version see page 642 of {{cite journal|vauthors=Chumakov PM, Morozova VV, Babkin IV, Baikov IK, Netesov SV, Tikunova NV | title=Oncolytic enteroviruses | journal=Molecular Biology | year= 2012 | volume= 46 | issue= 5 | pages= 639–50 | pmid= | doi=10.1134/S0026893312050032 | pmc= |url=http://www.virotherapy.eu/publications/preclinical/oncolytic-enteroviruses-2012.pdf}}<br/>
For the original version in Russian see {{cite journal|vauthors=Chumakov PM, Morozova VV, Babkin IV, Baĭkov IK, Netesov SV, Tikunova NV | title=[Oncolytic enteroviruses] (Russian). | journal=Molekulyarnaya Biologiya | year= 2012 | volume= 46 | issue= 5 | pages= 712–25 | pmid=23156670 | doi= | pmc= }}</ref> It was developed in the 1960s and 1970s by the team of [[Aina Muceniece]] (1924–2010) and received first patent in 2002.<ref>{{cite web|title=Inventions and Inventors of Latvia|url=http://izgudrojumi.lza.lv/izg_en.php?id=68|accessdate=8 April 2013}}</ref><ref name="patent2002">{{cite patent |country=EP |number=1537872 |status=application |title=Immunostimulator having antineoplastic action and method for producing said immunostimulator |pubdate=2005-06-08 | fdate= 2003-06-13 |pridate=2002-06-14 |inventor=Aina Muceniece}}</ref> In 2016 patent was renewed worldwide <ref name="patent2016">{{cite patent |country=EP |number=CN105518128 |status=application |title=Genetically stable oncolytic RNA virus, method of manufacturing and use thereof
For the original version in Russian see {{cite journal|vauthors=Chumakov PM, Morozova VV, Babkin IV, Baĭkov IK, Netesov SV, Tikunova NV | title=[Oncolytic enteroviruses] (Russian). | journal=Molekulyarnaya Biologiya | year= 2012 | volume= 46 | issue= 5 | pages= 712–25 | pmid=23156670 | doi= | pmc= }}</ref> It was developed in the 1960s and 1970s by the team of [[Aina Muceniece]] (1924–2010) and received first patent in 2002.<ref>{{cite web|title=Inventions and Inventors of Latvia|url=http://izgudrojumi.lza.lv/izg_en.php?id=68|accessdate=8 April 2013}}</ref><ref name="patent2002">{{cite patent |country=EP |number=1537872 |status=application |title=Immunostimulator having antineoplastic action and method for producing said immunostimulator |pubdate=2005-06-08 | fdate= 2003-06-13 |pridate=2002-06-14 |inventor=Aina Muceniece}}</ref> In 2016 patent was renewed worldwide <ref name="patent2016">{{cite patent |country=EP |number=CN105518128 |status=application |title=Genetically stable oncolytic RNA virus, method of manufacturing and use thereof |pubdate=2016-04-20 | inventor= VENSKUS DITE; KALVINS IVARS; PJANOVA DACE; PETROVSKA RAMONA; AUZINS JURGIS}}</ref> , in 2010 RIGVIR trademark has been registered in EUIPO. <ref>{{Cite web|url=https://euipo.europa.eu/eSearch/#basic/1+1+1+1/100+100+100+100/RIGVIR |title=RIGVIR trademark registration information |last=https://euipo.europa.eu |url=https://euipo.europa.eu|language=ENG| access-date=16 October 2017}}</ref>
|pubdate=2016-04-20 | inventor= VENSKUS DITE; KALVINS IVARS; PJANOVA DACE; PETROVSKA RAMONA; AUZINS JURGIS}}</ref> , in 2010 RIGVIR trademark has been registered in EUIPO. <ref>{{Cite web|url=https://euipo.europa.eu/eSearch/#basic/1+1+1+1/100+100+100+100/RIGVIR |title=RIGVIR trademark registration information |last=https://euipo.europa.eu |url=https://euipo.europa.eu|language=ENG| access-date=16 October 2017}}</ref>




[[File:Virions of enteroviruses in Rigvir.jpg|thumb|Virions of enteroviruses in Rigvir]]
[[File:Virions of enteroviruses in Rigvir.jpg|thumb|Virions of enteroviruses in Rigvir]]


RIGVIR was registered for treatment of cutaneous melanoma in Latvia on 29 April 2004, a few days before Latvia [[2004 enlargement of the European Union|joined]] the European Union.<ref name="latvia2004">{{cite web |url=http://www.zva.gov.lv/zalu-registrs/?iss=1&lang=en&q=Rigvir&ON=&SN=& |title=Rigvir šķīdums injekcijām |trans-title=Rigvir solution for injection |author=<!--Staff writer(s); no by-line.--> |date=2004-04-29 |website=Medicinal product register of the Republic of Latvia |access-date=2016-11-02}}</ref> Since Rigvir was registered via a national registration procedure, it has not been tested in the standard [[clinical trial]]s required for central registration in the European Union.<ref>{{cite web |url=https://ec.europa.eu/easme/en/sme/9443/feasibility-study-registration-medicine-rigvir-european-medicine-agency |title=Feasibility study for registration of medicine RIGVIR with the European Medicine Agency |author=<!--Staff writer(s); no by-line.--> |date=2016-01-08 |website=European Commission |archive-url=https://web.archive.org/web/20161102145626/https://ec.europa.eu/easme/en/sme/9443/feasibility-study-registration-medicine-rigvir-european-medicine-agency |archive-date=2016-11-02 |dead-url=no |access-date=2016-11-02 |quote=However, further use and commercialisation in the EU is prevented as EU regulations require cancer medicines to be registered centrally through the European Medicine Agency (EMA). National registrations are not considered.}}</ref>
RIGVIR was registered for treatment of cutaneous melanoma in Latvia on 29 April 2004, a few days before Latvia [[2004 enlargement of the European Union|joined]] the European Union.<ref name="latvia2004">{{cite web |url=http://www.zva.gov.lv/zalu-registrs/?iss=1&lang=en&q=Rigvir&ON=&SN=& |title=Rigvir šķīdums injekcijām |trans-title=Rigvir solution for injection |author=<!--Staff writer(s); no by-line.--> |date=2004-04-29 |website=Medicinal product register of the Republic of Latvia |access-date=2016-11-02}}</ref> Since Rigvir was registered via a national registration procedure, it has not been tested in the standard [[clinical trial]]s required for central registration in the European Union.<ref>{{cite web |url=https://ec.europa.eu/easme/en/sme/9443/feasibility-study-registration-medicine-rigvir-european-medicine-agency |title=Feasibility study for registration of medicine RIGVIR with the European Medicine Agency |author=<!--Staff writer(s); no by-line.--> |date=2016-01-08 |website=European Commission |archive-url=https://web.archive.org/web/20161102145626/https://ec.europa.eu/easme/en/sme/9443/feasibility-study-registration-medicine-rigvir-european-medicine-agency |archive-date=2016-11-02 |dead-url=no |access-date=2016-11-02 |quote=However, further use and commercialisation in the EU is prevented as EU regulations require cancer medicines to be registered centrally through the European Medicine Agency (EMA). National registrations are not considered.}}</ref> In 2016 RIGVIR started the way to EU registration process by receiving individually developed “road map” from EMA for RIGVIR medicine registration.<ref>{{Cite web|url=http://cordis.europa.eu/result/rcn/198670_en.html |title=European Commission RIGVIR report summary |last=http://cordis.europa.eu/result/rcn/198670_en.html |url=http://cordis.europa.eu/result/rcn/198670_en.html|language=ENG| access-date=15 October 2017}}</ref> <ref>{{Cite web|url=http://www.tvnet.lv/zinas/latvija/679843-izstrada_jaunus_petijumus_lai_rigvir_varetu_registret_ari_eiropas_zalu_agentura |title=Izstrādā jaunus pētījumus, lai «Rigvir» varētu reģistrēt arī Eiropas Zāļu aģentūrā |trans-title=New research is under way to allow Rigvir to be registered in the European Medicines Agency |last=http://www.tvnet.lv |url=http://www.tvnet.lv/zinas/latvija/679843-izstrada_jaunus_petijumus_lai_rigvir_varetu_registret_ari_eiropas_zalu_agentura|language=lv-LV| access-date=5 October 2017}}</ref>


There is no good evidence that RIGVIR is an effective cancer treatment and a number of medical organisations have complained to the Latvian government about the dubious science used to promote it.<ref name=sbm/> Its promotion has been described as likely being an instance of cancer [[quackery]].<ref name=sbm/>
There is no good evidence that RIGVIR is an effective cancer treatment and a number of medical organisations have complained to the Latvian government about the dubious science used to promote it.<ref name=sbm/> Its promotion has been described as likely being an instance of cancer [[quackery]].<ref name=sbm/>

Revision as of 06:15, 18 October 2017

RIGVIR (Riga virus) is a virotherapy medication approved by the State Agency of Medicines of the Republic of Latvia.[1] It was developed in the 1960s and 1970s by the team of Aina Muceniece (1924–2010) and received first patent in 2002.[2][3] In 2016 patent was renewed worldwide [4] , in 2010 RIGVIR trademark has been registered in EUIPO. [5]


Virions of enteroviruses in Rigvir

RIGVIR was registered for treatment of cutaneous melanoma in Latvia on 29 April 2004, a few days before Latvia joined the European Union.[6] Since Rigvir was registered via a national registration procedure, it has not been tested in the standard clinical trials required for central registration in the European Union.[7] In 2016 RIGVIR started the way to EU registration process by receiving individually developed “road map” from EMA for RIGVIR medicine registration.[8] [9]

There is no good evidence that RIGVIR is an effective cancer treatment and a number of medical organisations have complained to the Latvian government about the dubious science used to promote it.[10] Its promotion has been described as likely being an instance of cancer quackery.[10]

Efficacy

Manufacturers of Rigvir have a history of receiving fines for off-label marketing this anti-cancer drug directly to general public and cancer patients.[11][12][13] Oncologists and other medical experts in Latvia have repeatedly expressed the concern for the lack of clinical trials and evidence of efficacy, as well as unethical advertising.[14] In February 2017, Association of Oncologists, Association of Chemotherapists, Association of Rare Diseases of Latvia, and the Head of Pharmacology Department of Stradini University submitted a request to the Ministry of Health of Latvia, State Agency of Medicines, and National Health Service. They requested the removal of Rigvir from the Register of Medicines of Latvia and from the list of state-compensated medicines.[10] A revision of clinical treatment guidelines for melanoma was also requested.[15] The request was based on the analysis of available research and suggests that there is no conclusive evidence for the efficacy of Rigvir as a cancer treatment.[16]

Oncologist David Gorski has written that "There are many aspects to the Rigvir story that strongly suggest that Rigvir is probably cancer quackery" citing the "mysterious creator" aspect, the misleading description of the product as "natural" and the use of testimonials to market it.[10]

Side effects

The most commonly reported side effects are subfebrile temperature, pain in the tumor, fatigue, drowsiness, and dyspepsia (diarrhea).[17][6]

History

Rigvir antigen in tumor cells
  • In 1960 unknown phenomenon was discovered: when human enteric viruses (enteroviruses of group ECHO), which were isolated from the gastrointestinal tract of young children and grafted into hamster buccal bags showed oncotropic and oncolytic properties.[18]
  • In 1965, cancer virotherapy laboratory was founded in the Institute of Microbiology (Latvian Academy of Sciences) to explore this phenomenon. 60 different types of enteric viruses were tested, 5 of them were identified as the most effective viruses capable of destroying cancer cells. One of them, ECHO-7, was named Rigvir (Riga virus). It was found that Rigvir is safe for adults and not able to replicate in the human body.[19]
  • In 1968 scientists received permission from the Ministry of Health of the Latvian SSR to study and use Rigvir on patients, with the participation of 415 patients. It has been proven that Rigvir was safe for cancer patients and can not cause epidemics. Successful adaptation of the virus in the tissues of cutaneous melanoma (not sensitive to chemotherapy and radiotherapy) was produced, and the therapeutic effect was ascertained.[19] [verification needed]
  • On October 20, 2002 a patent was granted for Rigvir[3]
  • On April 29, 2004 Rigvir was approved for cutaneous melanoma by the State Agency of Medicines of the Republic of Latvia.[6]
  • Since 2011 Rigvir is included in the list of state compensated drugs to the diagnosis of malignant melanoma of the skin (the exception – ocular melanoma) for residents of Latvia.[citation needed]
  • In February 2015 registered in Georgia.[20]
  • In 2015 Rigvir was included in Latvian clinical guidelines for skin cancer and melanoma, published by National Health Service of Latvia. Page 11 specifies that, according to the criteria of European Society for Medical Oncology outlined in pages 7–8, evidence level for Rigvir even in the case of skin melanoma (which is the only indication Rigvir is registered for) is III/C, meaning: "insufficient evidence of efficacy, or benefits do not exceed disadvantages (negative outcomes, cost of treatment and other risks); optional use". Clinical guidelines were developed under the management of professor Dace Baltiņa (page 2), who later became the medical director of Global Virotherapy Cancer Clinic, the main treatment center in Latvia providing Rigvir and part of Rigvir holding.
  • In 2016 RIGVIR was approved in Armenia.[21]
  • In July 2016, the European Commission's Horizon 2020 program awarded a grant to Latima for the commercialisation of Rigvir in EU markets.[22][23]
  • On August 29, 2016 National Health Inspectorate of Latvia published a decision to apply a fine to SIA Latima, manufacturer of Rigvir, according to the Law on the Prohibition of Unfair Commercial Practices. After investigating the advertisements of prescription medicine Rigvir on the Internet and a magazine, Health Inspectorate decided that SIA Latima, the marketing authorization holder of Rigvir, has engaged in misleading commercial practice without due professional care, as the advertisements violate the requirements of Cabinet of Ministers regulation No.378, which specify that advertising prescription medicine to the general public is forbidden and that the information contained in advertisement has to match the information provided in the product characteristics. While Rigvir was only registered for treatment of cutaneous melanoma, it is being advertised for various cancers without any evidence of efficacy by International Virotherapy Centre in Latvia, the main institution providing treatment with Rigvir, as well as its accredited partners, e.g., exclusive partner in Mexico, alternative cancer clinic Hope 4 Cancer Institute, which offers untested and unproven therapies, such as coffee enemas and juice detoxes. Since Latvia is a member of European Union, according to Article 88 (DIRECTIVE 2001/83/EC on the Community code relating to medicinal products for human use), Member States shall prohibit the advertising to general public of medicinal products which are available on medical prescription only (page 26).

See also

References

  1. ^ For a freely accessible English version see page 642 of Chumakov PM, Morozova VV, Babkin IV, Baikov IK, Netesov SV, Tikunova NV (2012). "Oncolytic enteroviruses" (PDF). Molecular Biology. 46 (5): 639–50. doi:10.1134/S0026893312050032.
    For the original version in Russian see Chumakov PM, Morozova VV, Babkin IV, Baĭkov IK, Netesov SV, Tikunova NV (2012). "[Oncolytic enteroviruses] (Russian)". Molekulyarnaya Biologiya. 46 (5): 712–25. PMID 23156670.
  2. ^ "Inventions and Inventors of Latvia". Retrieved 8 April 2013.
  3. ^ a b EP application 1537872, Aina Muceniece, "Immunostimulator having antineoplastic action and method for producing said immunostimulator", published 2005-06-08 
  4. ^ EP application CN105518128, VENSKUS DITE; KALVINS IVARS; PJANOVA DACE; PETROVSKA RAMONA; AUZINS JURGIS, "Genetically stable oncolytic RNA virus, method of manufacturing and use thereof", published 2016-04-20 
  5. ^ https://euipo.europa.eu. "RIGVIR trademark registration information" (in ENG). Retrieved 16 October 2017. {{cite web}}: External link in |last= (help)CS1 maint: unrecognized language (link)
  6. ^ a b c "Rigvir šķīdums injekcijām" [Rigvir solution for injection]. Medicinal product register of the Republic of Latvia. 2004-04-29. Retrieved 2016-11-02.
  7. ^ "Feasibility study for registration of medicine RIGVIR with the European Medicine Agency". European Commission. 2016-01-08. Archived from the original on 2016-11-02. Retrieved 2016-11-02. However, further use and commercialisation in the EU is prevented as EU regulations require cancer medicines to be registered centrally through the European Medicine Agency (EMA). National registrations are not considered. {{cite web}}: Unknown parameter |dead-url= ignored (|url-status= suggested) (help)
  8. ^ http://cordis.europa.eu/result/rcn/198670_en.html. "European Commission RIGVIR report summary" (in ENG). Retrieved 15 October 2017. {{cite web}}: External link in |last= (help)CS1 maint: numeric names: authors list (link) CS1 maint: unrecognized language (link)
  9. ^ http://www.tvnet.lv. "Izstrādā jaunus pētījumus, lai «Rigvir» varētu reģistrēt arī Eiropas Zāļu aģentūrā" [New research is under way to allow Rigvir to be registered in the European Medicines Agency] (in Latvian). Retrieved 5 October 2017. {{cite web}}: External link in |last= (help)
  10. ^ a b c d Gorski D (18 September 2017). "Rigvir: Another unproven and dubious cancer therapy to be avoided". Science-Based Medicine.
  11. ^ http://www.vi.gov.lv/lv/sakums/aktuali/this-just-in/pienemts-lemums-par-naudas-soda-piemerosanu-zalu-rigvir-par-negodigu-komercpraksi
  12. ^ http://skepticisms.lv. "Rigvir: When Science Takes A Back Seat". skepticisms.lv (in Latvian). Retrieved 2017-08-08. {{cite web}}: External link in |last= (help)
  13. ^ "Veselības inspekcija par neatļautu 'Rigvir' reklamēšanu piemērojusi naudas sodu SIA 'Latima'". Delfi.lv. {{cite news}}: Cite has empty unknown parameter: |dead-url= (help)
  14. ^ Ritums, Eduards (October 2016). "When science takes a back seat". {{cite web}}: Cite has empty unknown parameter: |dead-url= (help)
  15. ^ Stirāne, Dace. "Latvia to review state compensation for Rigvir anti-cancer drug". Public broadcasting of Latvia. {{cite news}}: Cite has empty unknown parameter: |dead-url= (help)
  16. ^ Nagle, Gunita. "Onkologi prasa izņemt "Rigvir" no Zāļu reģistra". irlv.lv. {{cite web}}: Cite has empty unknown parameter: |dead-url= (help)
  17. ^ "RIGVIR Side Effects". RIGVIR. Archived from the original on 2016-11-13. {{cite web}}: Unknown parameter |dead-url= ignored (|url-status= suggested) (help)
  18. ^ Muceniece A.J. 1978. Analysis of sensitivity of human melanomas to enteroviruses adaptred to these tumors.In: Virusy v terapii opukholei (Viruses in Antitumor Therapy), Riga: Zinatne, pp. 175–189.
  19. ^ a b Muceniece A.J., Bumbieris J.V. 1982. Transplantation antigens and their changes in carcinogenesis and viral infection. In: Virusnyi onkoliz i iskusstvennaya geterogenizatsiya opukholei (Viral Oncolysis and Artificial Heterogenization of Tumors). Riga, pp. 217–234.
  20. ^ Karsaulidze, Eka (2015). "Georgia's Aversi Now Selling Riga Virus Cancer Treatment". Georgia Today. Archived from the original on 2016-03-12. Retrieved 2016-11-03. Rigvir was officially registered by the Ministry of Labor, Health and Social Affairs of Georgia on February 15, 2015. {{cite web}}: Unknown parameter |dead-url= ignored (|url-status= suggested) (help)
  21. ^ "Latvian Rigvir anti-cancer medicine registered in Armenia".
  22. ^ Petrán, Leide (12 July 2016). "Rigvir saņem Eiropas Komisijas grantu medikamenta komercializācijai ES tirgū" [Rigvir receives European Commission grant for the commercialization of the medicine in the EU market]. Dienas Bizness (in Latvian). Retrieved 2017-01-09.
  23. ^ "EC awards grant to commercialise Latima's cancer virotherapy medicine". Pharmaceutical Technology. 22 July 2016. Retrieved 2017-01-09.
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