Cerulean Pharma has dosed the first patient in a Phase 2 study of its investigational CRLX101 drug, designed for the treatment of extensive-stage small cell lung cancer (SCLC) patients sensitive to first-line platinum-based chemotherapy.
CRLX101, a tumor-targeted nanopharmaceutical, is a dual inhibitor of topoisomerase 1 and hypoxia-inducible factor-1a and releases camptothecin over an extended period of time.
The randomized study, which is being conducted at the University of Chicago School of Medicine and affiliated institutions, has enrolled 150-patient to compare the efficacy of CRLX101 with topotecan, a second-line therapy for relapsed SCLC.
The trial has co-primary endpoints of progression-free survival (PFS) and three-month PFS rate, claims the company.
During the company’s preclinical and Phase 1/2a clinical trial, CRLX101 has demonstrated significant anti-tumor activity.
Cerulean Pharma chief medical officer Edward Garmey said the company’s clinical experience with CRLX101 shows a benign safety profile.
"The standard of care in SCLC is not well tolerated, so if we can demonstrate an efficacy benefit versus standard of care, CRLX101 would have the added benefit of improved quality of life for these very sick patients," Garmey added.