[A preliminary clinical safety evaluation of parvovirus H-1 on cancer therapy]

To make a preliminary evaluation of parvovirus H-1 for its safety in clinical use.

In this study, clinical safety of H-1 in cancer therapy was examined using the Ames test, the mammalian cell chromosome aberration test, the micronucleus calculation of mouse bone marrow cells, the allergy test and the pyrogenicity test.

Negative results were observed in all the tests. The mouse tolerance test showed that the tolerance limit was at least 5 x 10(11) plaque-forming units/kg weight, which was 2500 times higher than the supposed clinical dose. The H-1 host NB-324K cells were also tested using the anchorage-independent assay and the tumour formation in nude mice. Both of the assays gave negative results.

All these results preliminarily showed that the H-1 was safe in cancer therapy.