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The antitumor effect of IHL-305, a novel pegylated liposome containing irinotecan,was investigated in human xenograft models. After subcutaneous transplantationof several human cancer cell lines (colorectal, non-small cell lung, small celllung, prostate, ovarian and gastric cancer cells) to nude mice, IHL-305 or CPT-11was administered intravenously 3 times at 4-day intervals. In all xenograft modelstested, IHL-305 showed superior antitumor activity to that of CPT‑11 and a comparabletumor-growth-inhibitory effect at one-eighth or less of the dose of CPT-11, evenagainst HT-29 colorectal and NCI-H460 non-small cell lung cancer cell lines, whichshow intrinsic resistance to CPT-11. A single injection or 2 injections of IHL-305on several dosing schedules also resulted in a significant antitumor effect comparedto that of vehicle control in a dose-dependent manner and showed comparable antitumoractivity at about one-fifth the dose of the maximum tolerated dose of CPT-11.The analysis of the concentrations of irinotecan and SN-38, an active metaboliteof CPT-11, in plasma and tumors revealed that irinotecan was maintained at highconcentrations, and the prolonged presence of SN-38 in plasma and tumors in IHL-305treated mice compared with CPT-11-treated mice. Therefore, the stronger tumorinhibitory effect of IHL-305, as compared to CPT-11, was associated with the differencein the concentration of irinotecan in plasma or tumors after each agent was administeredand with the maintainance of a higher concentration of SN-38. These results indicatethat IHL-305 demonstrated superior antitumor activity against a wide range oftumors at lower doses than CPT-11.

Antitumor activity of IHL-305, a novel pegylated liposome containing irinotecan, in human xenograft models