Lipodox® (generic doxorubicin hydrochloride liposome injection): in vivo efficacy and bioequivalence versus Caelyx® (doxorubicin hydrochloride liposome injection) in human mammary carcinoma (MX-1) xenograft and syngeneic fibrosarcoma (WEHI 164) mouse models

Table 3 Comparison of SGD and other parameters of SPIL and reference DXR HCl liposome injections^a

Treatment (dose)	Median tumour volume (days)	SGD	CR/total (n/n)	PR/total (n/n)	DCR (days)	TFS/TR (n/n)
Syngeneic fibrosarcoma mouse model
Placebo	14	-	0/15	-	-	0/0
SPIL DXR HCl liposome injection 9 mg/kg	>28^b	>1	3/11	8/11	21	3/0
Reference DXR HCl liposome injection 9 mg/kg	>28^b	>1	7/15	7/15	28	7/0
Human mammary carcinoma xenograft mouse model
Placebo	19.00	-	-	-	-	-
SPIL DXR HCl liposome injection 1.5 mg/kg	28.00	0.5	0/10	0/10	NA	NA
Reference DXR HCl liposome injection 1.5 mg/kg	28.00	0.5	0/10	0/10	NA	NA
SPIL DXR HCl liposome injection 3 mg/kg	35.00	0.8	1/10	0/10	38	1/0
Reference DXR HCl liposome injection 3 mg/kg	28.00	0.5	0/10	0/10	NA	NA
SPIL DXR HCl liposome injection 6 mg/kg	42.00	1.2	1/10	2/10	28	1/0
Reference DXR HCl liposome injection 6 mg/kg	>42^c	>1.2	0/10	2/10	NA	NA

Abbreviations: CR/total (n/n) animals with complete tumour regression/total no. of animals, DCR median duration of complete tumour regression in days, DXR doxorubicin, HCl hydrochloride, PR/total (n/n) animals with partial tumour regression/total no. of animals, SGD specific tumour growth delay, SPIL Sun Pharmaceutical Industries Ltd., TFS/TR no. of tumour free survivors/no. of tumour recurrences
^aSGD and other parameters were calculated from tumour volume data. The efficacy criteria for SGD parameter was >1. Tumour regression was recorded as partial (PR) if the tumour volume decreased to less than 50% of the tumour volume at the start of the treatment without dropping below measurable size, or as complete (CR) if the tumour burden had become impalpable.
^bNone of the animals reached two volume doublings from initial tumour volume at the start of treatment. Hence median time to reach two tumour volume doublings was considered as >28 days.
^cNone of the animals reached two volume doublings from initial tumour volume at the start of treatment. Hence median time to reach two tumour volume doublings was considered as >42 days.

ISSN: 1471-2407