Table 1.
Summary of toxicity, biosafety and therapeutic response
Dogs diagnosed with various types of cancer were enrolled and treated with the indicated dose of VSV-hIFNβ-NIS or VSV-cIFNβ-NIS. Heptatotoxicity, the primary dose limiting toxicity is described. Safety data indicate samples tested for IVR are negative (−). Summary of therapeutic response during the 28 day study period is indicated (PR: Partial response).
| STUDY ID | BREED, SEX & AGE | DISEASE TYPE | TX (& TX TIME) | TOXICITY | SAFETY (IVR) | OUTCOME | |
|---|---|---|---|---|---|---|---|
| 1 | UTK01 | Mix, Female (spayed) 10 yrs | Anal Adeno-carcinoma |
1.6×1010 TCID50 VSV-hIFN-NIS (At Diagnosis) |
No notable adverse events | Urine (−) Buccal (−) |
STABLE DISEASE 30 days; followed by tumor resection |
| 2 | UTK02 | Mix, Male (Cast.) 10yrs | Multiple Myeloma (IgA) |
1×1010 TCID50 VSV-cIFN-NIS (At Diagnosis) |
Mild/transient ALT elev. | Urine (−) Buccal (−) |
STABLE DISEASE |
| 3 | UTK03 | German Shepherd, Female, (spayed); 8 yrs | B-cell lymphoma (peripheral LN) |
2.4×1010 TCID50 VSV-cIFN-NIS (At Diagnosis) |
Mild/transient ALT increase | Urine (−) Buccal (−) |
STABLE DISEASE |
| 4 | UTK04 | Boxer, Male (Cast.) 8yrs | T-cell lymphoma |
2.2×1010 TCID50 VSV-hIFN-NIS (At Diagnosis) |
2X ULN ALT elevation, transient, self-limiting | Urine (−) Buccal (−) |
PARTIAL RESPONSE Rapid disease remission, relapse PR: ~21 days |
| 5 | UTK05 | Mix, Male (Cast.) 6yrs | B-cell lymphoma (peripheral LN) |
1.7×1010 TCID50 VSV-hIFN-NIS (At Diagnosis) |
Mild/transient ALT increase | Urine (−) Buccal (−) |
PROGRESSIVE DISEASE |
| 6 | UTK06 | Schnauzer Female (spayed) 10yrs | Multifocal cutaneous melanoma |
1.02×1010 TCID50 VSV-cIFN-NIS (At Diagnosis) |
Mild/transient ALP increase | Urine (−) Buccal (−) |
STABLE DISEASE |
| 7 | UTK07 | Hound Mix, Female (spayed) 12 yrs | B-cell lymphoma (peripheral LN) |
1.7×1010 TCID50 VSV-cIFN-NIS (Refractory disease) |
No notable adverse events | Urine (−) Buccal (−) |
PROGRESSIVE DISEASE (rapid progression) |
| 8 | UTK08 | Boxer, Female (spayed) 10yrs | T-cell lymphoma |
2.2×1010 TCID50 VSV-hIFN-NIS (At Diagnosis) |
10X ULN ALT elevation, transient, self-limiting | Urine (−) Buccal (−) |
PARTIAL RESPONSE Rapid disease remission, relapse PR: ~36 days |
| 9 | UTK09 | Pembroke Welsh Corgi Female (spayed) 11 yrs | B-cell lymphoma |
1.2×1010 TCID50 VSV-cIFN-NIS (Refractory disease) |
No notable adverse events | Urine (−) Buccal (−) |
PROGRESSIVE DISEASE Brief, transient response and disease progression |
| 10 | UTK10 | Metastatic OS, maxillary lesion and lung mets |
2 doses of 2.2×1010 TCID50 VSV-hIFN-NIS @ 0 and 48h (At Diagnosis) |
No notable adverse events | Urine (−) Buccal(−) |
STABLE DISEASE SD 6 months; maxillary lesion progression @ 6m |