4. Resultados y discusión
4.4. Estudio legal
4.1.8 Requerimientos para el funcionamiento de la industria de las bebidas de quinua
We have opened a clinical trial with vvdd-hCD40L-tdTomato for dogs with incurable solid tumours. For SFV, more tumour cell lines, especially glioma cells, will be tested for oncolytic capacity of the virus and also the efficacy could be evaluated in tumour biopsies. If the virus proves effective, we intend to open a clinical trial for dogs with glioma as well.
Due to the similarity between canine and human spontaneous tumours (Ranieri et al., 2013, Vail and Thamm, 2011, Vail and MacEwen, 2000), the information yielded from the clinical trials in dogs is anticipated to also benefit human oncology and to reveal key safety and efficacy aspects not evident in rodents.
7 CONCLUSIONS
Based on these studies, the following conclusions can be drawn:
1. Oncolytic vvdd infected and killed canine osteosarcoma (Abrams and D17) and prostatic carcinoma (ACE-1) cell lines, infected canine tumour biopsies and slowed tumour growth in nude mouse prostatic carcinoma (ACE-1) xenograft. Thus, oncolytic vaccine virus expressing hCD40L has anti-tumoural efficacy against tested canine cell lines in vitro and in vivo.
2. Oncolytic vvdd infected and killed feline squamous cell line SCCF1 cells, but the killing efficacy was lost when the cells grew in an intact monolayer. Infectious virions were still produced, but they were morphologically abnormal probable due to their inability to form core units from viral DNA and to form mature virions. Specific features of the cell line may be responsible for the abnormal morphology.
3. Intravenous administration of a high dose of oncolytic Western Reserve vaccinia virus vvdd-tdTomato-hCD40L was safe in healthy dogs despite the potential seizure in one dog. Infectious virus was only found in the blood samples taken immediately after virus infusion and not in saliva, urine or faeces.
4. Attenuated SFV infected and killed tested canine osteosarcoma cell lines (Abrams and D17), and intravenous administration of the virus caused no adverse events in healthy dogs and infectious virus was not found in blood, urine or faeces. Based on our results, attenuated SFV and its derivatives are potential candidates for further studies in canine cancer cell lines, tumour biopsies and finally tumour-bearing dogs.
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