Cerulean initiates CRLX101 Phase 2 study in extensive-stage small cell lung cancer

Cerulean Pharma Inc., a leader in developing dynamically tumor-targeted nanopharmaceuticals, today announced that the first patient has been dosed in a randomized Phase 2 study of its lead candidate, CRLX101, in patients with extensive-stage small cell lung cancer (SCLC) sensitive to first-line platinum-based chemotherapy.

With the 150-patient randomized Phase 2 study in advanced non-small cell lung cancer expected to read out soon, Cerulean is broadening the CRLX101 opportunity in lung cancer. This newly opened, randomized trial is designed to compare the efficacy of CRLX101, a nanopharmaceutical that inhibits both topoisomerase 1 and hypoxia-inducible factor-1 alpha (HIF-1α), to topotecan as second-line therapy for relapsed SCLC. Topotecan is the only approved second-line therapy for relapsed SCLC, and it offers a median survival of 33 to 35 weeks, in many cases with severe myelosuppressive toxicity. The study, with co-primary endpoints of progression-free survival (PFS) and three-month PFS rate, will assess whether CRLX101 can demonstrate enhanced efficacy with a favorable safety profile compared to the only approved second-line therapy in SCLC.

The study is being conducted at the University of Chicago School of Medicine and affiliated institutions. It is being led by principal investigators Thomas Hensing, M.D., and Ravi Salgia, M.D., Ph.D.

"Relapsed SCLC is a treatment setting that has very limited therapeutic options," said Edward Garmey, M.D., chief medical officer of Cerulean. "Our 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. We are pleased to be working with world leaders in SCLC on such an important trial."

"I am excited by the opportunity to study CRLX101 in the treatment of advanced SCLC patients," said Dr. Salgia. "This randomized study should answer the question of whether CRLX101 can meaningfully impact an area of severely unmet medical need."