Animal Studies
CRLX101 (formerly IT-101) was studied in mouse xenografts using different cancer models and showed good tolerability and anti-cancer effectiveness in a variety of tumors. A pharmacokinetic and biodistribution study in rats and tumor-bearing mice demonstrated that ntravenous administration of IT-101 gave prolonged plasma half-life and enhanced distribution to tumor tissue when compared to camptothecin alone. The data also show that active camptothecin is released from the conjugate within the tumor for an extended period of time. These effects likely play a significant role in the enhanced antitumor activity of IT-101 when compared to CPT alone or irinotecan. In addition, multiorgan pharmacokinetics and accumulation in tumor tissue of IT-101 was investigated by using PET. The calculated tumor vascular permeability indicates that the majority of nanoparticles stay intact in circulation and do not disassemble into individual polymer strands. A key assumption to modeling the tumor dynamics is that there is a "sink" for the nanoparticles within the tumor. Histological measurements using confocal microscopy show that IT-101 localizes within tumor cells and provides the sink in the tumor for the nanoparticles.
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