Although survival for neuroblastoma (NB) in newly diagnosed high-risk children has improved, recurrent disease remains a significant problem with treatment options limited by both anti-tumor efficacy and patient tolerance. We previously demonstrated that neural stem cells (NSCs), engineered to secrete a modified rabbit carboxylesterase (rCE-NSCs) can distribute to metastatic neuroblastoma tumor foci in multiple organs, and convert the prodrug CPT-11 (Irinotecan; IRN) to the 1000 fold more potent topoisomerase-1 inhibitor, anti-cancer agent SN-38, resulting in significant therapeutic efficacy. The goal of our current biodistribution, efficacy and safety/toxicity IND-enabling studies is to identify the optimal dose and schedule of intravenously administered NSCs adenovirally transduced to secrete a modified human CE (hCE1m6), followed by human equivalent doses of IRN. This would ideally provide a tumor selective, more effective and potentially less toxic delivery of treatment for children with recurrent high-risk NB.
We have now determined the in vitro IC50 values of 4 human derived NB lines to SN-38, IRN only and IRN + hCE1m6-NSC conditioned media. IC50 values of IRN were decreased by 500 to 6000-fold when IRN was used in combination with the hCE1m6 conditioned media for all NB cell lines (KCNR, SKNAS, CHLA-136 and CHLA-255).
In subcutaneous models of human NB we demonstrated tumor-specific conversion of IRN to SN-38. We have also shown clearance of hCE1m6-NSCs through peripheral organs and circulation in non-tumor bearing Es1e/SCID mice by quantitative PCR. Repeated treatments with hCE1m6-NSCs in combination with intravenous IRN (15 mg/kg x 3 days) had a significant decrease of tumor burden (as measured by bioluminescent imaging) for CHLA-136 (1.6-fold /p = 0.003) and CHLA-255 (0.6-fold/p= 0.04) vs. IRN only group in metastatic tumor models. hCE1m6-NSCs with IRN increased long-term survival of mice bearing CHLA-136 and CHLA-255 NB tumors. These studies suggest NSC-mediated enzyme/prodrug therapy may have potential benefit for NB patients.