Cerulean Announces Completion of Enrollment of a Phase 1b/2 Study of CRLX101 in Combination with Avastin® in Relapsed Renal Cell Carcinoma

Cerulean Pharma Inc.

, a leader in Dynamic Tumor Targeting™, today announced completion of enrollment of 22 patients in a Phase 1b/2 clinical proof of principle trial of its lead nanoparticle-drug conjugate, CRLX101, in combination with Avastin® in relapsed renal cell carcinoma (RCC). This study is an investigator-sponsored trial (IST) being conducted by the University of Pennsylvania and Thomas Jefferson University Hospital with support from Cerulean. The Principal Investigator is Dr. Stephen Keefe of the University of Pennsylvania Abramson Cancer Center. “We have observed in interim data a response rate that is significantly higher than what has been seen historically with standard-of-care treatments and this response rate seems to be translating into clinical benefit for those patients,” said Dr. Keefe. “This trial continues to generate promising results, and I look forward to submitting final data for presentation at an upcoming medical meeting.” Data previously presented from the first 11 patients from this study showed a 27% response rate (three RECIST responses) in a setting where standard of care historically provides only a 2-4% response rate. A 7.6 months median progression-free (PFS) survival was observed, which is double the roughly 3.5 months PFS achieved by standard-of-care in this setting. Based on these data, Cerulean launched a company-sponsored randomized Phase 2 trial of CRLX101 in combination with Avastin in 3rd and 4th line RCC in August 2014, which is currently ongoing.