8 november 2018: Lees ook dit verslag van een man met uitgezaaide darmkanker die alnsog geneest d.m.v. immuuntherapie met het RIGVIR virus: 

https://kanker-actueel.nl/man-met-uitgezaaide-darmkanker-stadium-4-kras-pos-geneest-alsnog-met-combinatie-van-immuuntherapie-met-rigvir-virus-plus-folfox-en-bevacizumab-en-is-al-7-jaar-kankervrij.html

8 november 2018: Bron: European Journal of Pharmacology Volume 837, 15 October 2018, Pages 117-126

Immuuntherapie met gemoduleerde oncologische virussen is een snelgroeiend veld binnen de oncologie. Verschillende virussen zijn al vele malen in klinische trials onderzocht en een aantal daarvan zijn ook door FDA en EMU erkend als geregistreerd behandelingsvirus. Een van de eerste virussen, het Rigvir virus is een immuunstimulerend virus met bewezen therapeutische effecten bij o.a. melanomen, , lokale behandeling van huidkanker en onderhuidse uitzaaiingen van melanomen voor de preventie van uitzaaiingen en geregistreerd in o.a. Letland, Georgië, Armenië en Oezbekistaan.

Het doel van deze  overzichtsstudie is om een overzicht te geven van de ontwikkeling van het Rigvir virus en van andere virussen in het algemeen.

Uit de inleiding en abstract vertaald:

De veiligheid van het geselecteerde en aan het melanoom aangepaste ECHO-7-virus Rigvir werd getest bij meer dan 180 patiënten zonder ernstige bijwerkingen. Voordat de registratie een feit werd werden meer dan 700 kankerpatiënten behandeld met het RIGVIR virus: meer dan 540 melanoompatiënten en patiënten met late stadium maagkanker (ca. 90),  darmkanker (ca. 60 patiënten) en andere vormen van kanker met solide tumoren. Patiënten werden gedurende 3 jaar na de operatie met Rigvir behandeld en vergeleken met immunotherapie. 

De mediane 3- en 5-jaars totale overleving bleek beduidend hoger te zijn bij met het Rigvir virus behandelde patiënten. In opeenvolgende retrospectieve studies vertoonden de met Rigvir behandelde patiënten met stadium II-melanoom een 6,67-voudig verlaagd risico op ziekteprogressie in vergelijking met de patiënten die volgens de standaard richtlijnen waren behandeld, en stadium-IB en stadium-II melanoompatiënten die Rigvir-therapie hadden gekregen hadden een  4.39-6.57-voudig lager risico op overlijden. Deze resultaten worden bevestigd en uitgebreid met casestudies. 

Een andere studie:

In this study 44 Rigvir treated stage II melanoma patients were included, and 36 patients that had only been observed according to current international melanoma guidelines. Age and sex was not statistically significantly different between the groups (P > 0.05) (calculated from the data of Doniņa et al. (2012)).

The progression-free survival was analysed by Kaplan-Meier analysis (Fig. 5). The results show that the risk for disease progression (calculated as hazard ratio) was statistically significantly (P < 0.001) decreased 6.67-fold by Rigvir treatment compared to observation (Doniņa et al., 2012).

Fig. 5
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Fig. 5. Kaplan-Meier analysis plot of the effect of Rigvir on progression-free survival in stage II (A,B,C) melanoma patients following surgery. Rigvir N = 44

, Observation N = 36
. Statistical difference between groups: P < 0.001 (from Doniņa et al. (2012), with permission)

Lees ook dit studierapport van drie patienten (melanoom, longkanker en een botsarcoom) die allemaal succesvol hun kanker onder controle kregen met het RIGVIR virus: 

Long‐term treatment with the oncolytic ECHO‐7 virus Rigvir of a melanoma stage IV M1c patient, a small cell lung cancer stage IIIA patient, and a histiocytic sarcoma stage IV patient‐three case reports

Uit het studieverslag:

De hier beschreven patiënten werden 3,5, 7,0 en 6,6 jaar geleden gediagnosticeerd en hun toestand is verbeterd en stabiel gebleven gedurende respectievelijk 1,5, 6,5 en 4 jaar. Deze observaties suggereren dat virotherapie met behulp van Rigvir met succes kan worden gebruikt bij langdurige behandeling van patiënten met melanoom stadium IV M1c, kleincellig longkanker stadium IIIA en histiocytisch sarcoom stadium IV en daarom zouden kunnen worden opgenomen in prospectieve klinische onderzoeken.

image
Figure 4
Cytology of biopsy samples of the small cell lung cancer patient. Lymph node small cell cancer cells (purple) and erythrocytes (blue‐green). Light microscopy. Giemsa stain. Scale bar is 100 μm.

Bovenstaande is een verkorte versie van de introductie van deze grote reviewstudie: The advent of oncolytic virotherapy in oncology: The Rigvir® story

en beschrijft niet alleen de effecten van het RIGVIR virus bij melanomen maar bij veel andere verschillende vormen van kanker. Met overal studieverwijzingen enz. 

M.i. geeft deze overzichtsstudie een mooi beeld van de ontwikkeling van het RIGVIR virus maar ook van andere gemoduleerde virussen en wat immuuntherapie met een gemoduleerd virus kan betekenen in een behandeling van kanker.

Hier het abstract van de studie met referentielijst.

Rigvir is a promising immunotherapy medicine for the treatment of melanoma and prevention of metastases as a monotherapy, and potentially also in other cancers as well as in combination therapy.

European Journal of Pharmacology

Volume 837, 15 October 2018, Pages 117-126
European Journal of Pharmacology
Review

The advent of oncolytic virotherapy in oncology: The Rigvir® story

Abstract

Oncolytic viruses are a fast-developing cancer treatment field. Numerous viruses have been tested in clinical trials and three are approved. The first, Rigvir, is an immunomodulator with anti-tumour effect for treatment of melanoma, local treatment of skin and subcutaneous metastases of melanoma, for prevention of relapse and metastasis after radical surgery registered in Latvia, Georgia, Armenia and Uzbekistan. The aim of the present review is to summarize the development of Rigvir. Approximately 60 viruses were screened preclinically. Clinical safety and efficacy trials were with 5 oncolytic enteroviruses. Safety of the selected and melanoma-adapted ECHO-7 virus Rigvir was tested in over 180 patients with no severe adverse events observed. Pre-registration efficacy studies involved over 700 cancer patients: over 540 melanoma patients, and patients with late stage stomach (ca. 90), colorectal cancer (ca. 60), and other cancers. Patients were treated with Rigvir for 3 years after surgery and compared to immunotherapy: 3- and 5-year overall survival appeared to be increased in Rigvir treated patients. In post-marketing retrospective studies, Rigvir-treated stage II melanoma patients showed a 6.67-fold decreased risk for disease progression in comparison to those that had been observed according to guidelines, and stage IB and stage II melanoma patients that had received Rigvir therapy had 4.39–6.57-fold lower mortality. The results are confirmed and extended by case reports. Several immunological markers have been measured. In conclusion, Rigvir is an oncotropic and oncolytic virus for treatment of melanoma; the results will be confirmed and updated by modern clinical studies.

6. Conclusions

The present results suggest that Rigvir is the first oncolytic virotherapy that is approved for treatment of melanoma. It has been used also in several other cancers, for example, gastric and rectal cancer. Rigvir is a genetically non-modified, oncotropic and oncolytic ECHO-7 virus; the side effects are low grade and well tolerated. The first Rigvir marketing authorization was approved in 2004 and Rigvir has been reimbursed in Latvia since the middle of 2011, where over 2/3 of the reimbursed melanoma patients have been treated with Rigvir. Since most of the clinical studies were performed before 1991, the results would benefit from updated, modern safety and efficacy clinical studies. As a part of this, also appropriate biomarkers are being sought to more accurately identify the right target patient population to increase the response rate. Rigvir is a promising immunotherapy medicine for the treatment of melanoma and prevention of metastases as a monotherapy, and potentially also in other cancers as well as in combination therapy.

Conflicts of interest

AT, AR, KB, DV, and PA are employees of the International Virotherapy Center or its affiliates.

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Rigvir virus, immuuntherapie, overzichtsstudie, overall overleving, complete remissies, gemoduleerd virus


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