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Table 1 Summary of IL-12 gene therapy studies in veterinary medicine

From: IL-12 based gene therapy in veterinary medicine

  No. and type of animals included in the study Study design Type of treated tumors Type of gene delivery Route of gene delivery Type of therapeutic IL-12 gene Treatment outcome Ref
1 16 cats (GFP ± mIL-12) + 13 cats (fIL-12) phase I dose escalation study on naturally occurring tumors soft tissue sarcomas viral delivery (adenovirus controlled by heat-inducible promotor) i.tu. murine feline systemic toxicity at high adenoviral doses high expression of IL-12 in all tumors IFN-γ intratumoral expression detected only with high doses side effects correlated with IFN-γ expression [33]
2 7 horses phase I/II study on naturally occurring tumors metastatic melanoma direct plasmid injection i.tu. human 41% mean reduction of tumor size after single plasmid injection (11/12 treated tumors) CR after 3 plasmid injections in 1/12 tumors only short response (regrowth 11/12 tumors) histological change of treated tumors no side effects [46]
3 8 horses phase II/III placebo-controlled study on naturally occurring tumors metastatic melanoma direct plasmid injection i.tu. equine regression in tumor size, with mean volume of treated tumors decreasing to approximately 80% of baseline value side effect: local peritumoral oedema of smaller treated lesions [48]
4 7 horses pharmacokinetics study metastatic melanoma direct plasmid injection i.tu. equine plasmid enters peripheral blood 10 minutes after intratumoral DNA application and is present up to 36 hours post injection, with peak concentration at 30 minutes intratumoral expression of IFN-γ was detectable in all melanoma samples with high interindividual variability [47]
5 6 dogs dose escalating study on experimentally induced tumors transmissible venereal tumors EGT i.tu. human statistically significant growth delay of treated tumors CR in all of the treated tumors systemic release of IL-12 and/or IFN-γ antitumor effect on distant untreated tumors [66]
6 8 dogs phase I/II study on naturally occurring tumors mast cell tumors EGT i.tu. human 50% median reduction of tumor volumes (ranging from 15 – 83%) systemic release of IL-12 and/or IFN-γ change in histological structure of treated tumors [56]
7 7 dogs phase I feasibility and safety study N/A EGT i.m. human systemic release of IL-12 (1/6 dogs) induction of IFN-γ response (3/6 dogs) no detectable side effects [76]
8 6 dogs phase I/II study on naturally occurring tumors different types of tumors EGT i.m. human systemic release of IL-12 and/or IFN/γ in 4/6 animals prolongation of patients' life [65]
9 N/A description of ECGT protocol/case report head and neck tumors ECGT (IL12 + BLM) i.tu. N/A report on eradication of two tumors (the same two patients are also presented in the study under no. 10) [72]
10 6 dogs phase I/II study on naturally occurring tumors different types of highly malignant tumors ECGT (IL-12 + BLM) i.tu. feline CR 3/6 dogsPR 3/6 dogs [57]
  1. Ref: reference; GFP: green fluorescent protein; mIL-12: murine IL-12; fIL-12: feline IL-12; EGT: electrogene therapy; ECGT: electrochemogene therapy;i.tu. intratumoral; i.m.: intramuscular; BLM: bleomicyn; CR: complete response; PR: partial response.