Oncolytic viruses are a rapidly developing field of cancer treatment. Numerous viruses have been tested in clinical trials and three are approved. The first, Rigvir, is an immunomodulator with antitumor effect for the treatment of melanoma, local treatment of cutaneous and subcutaneous metastases of melanoma, for the prevention of relapses and metastases after radical surgery registered in Latvia, Georgia, Armenia and Uzbekistan . The objective of this review is to summarize the development of Rigvir.
History of RIGVIR SE
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Results:
Approximately 60 viruses were examined preclinically. Safety and efficacy clinical trials were conducted with 5 oncolytic enteroviruses. The safety of the selected and adapted melanoma virus, ECHO-7 virus Rigvir, was tested in more than 180 patients with no serious adverse events observed. Preregistration efficacy studies involved more than 700 cancer patients: more than 540 patients with melanoma, and patients with late-stage stomach cancer (approximately 90), colorectal cancer (approximately 60), and other cancers. Patients were treated with Rigvir for 3 years after surgery and compared with immunotherapy: 3- and 5-year overall survival appeared to be increased in patients treated with Rigvir. In retrospective post-market studies, patients with stage II melanoma treated with Rigvir showed a 6.67-fold lower risk of disease progression compared to those who had been observed according to guidelines, and patients with stage IB and stage II who had received Rigvir therapy had 4.39–6.57 times lower mortality. The results are confirmed and expanded by case reports. Several immunological markers have been measured.
Conclusion:
Rigvir is an oncotropic and oncolytic virus for the treatment of melanoma; The results will be confirmed and updated by modern clinical studies.