Cerulean Pharma Inc. has completed enrolment of a randomized phase II study of its lead candidate, CRLX101, in advanced non-small cell lung cancer (NSCLC). The company also announced that it has dosed the first patient in a second tumour type.

“Completing enrolment of our phase II study is a significant company milestone and speaks to our team’s ability to execute on the CRLX101 development program,” said Oliver Fetzer, Ph.D., president and chief executive officer of Cerulean. “CRLX101 is being evaluated to determine whether it can address the current treatment gap in NSCLC patients who are not likely to benefit from the approved molecularly targeted drugs. We believe that the biological activity observed in our phase I and phase II a studies is encouraging and supports the continued development of CRLX101 to evaluate whether it translates into clinical benefit for patients.”

The fully-enrolled 150-patient randomized phase II study is designed to assess the efficacy and safety of CRLX101 as a monotherapy for advanced NSCLC following one or two prior regimens of therapy. The primary endpoint of the study is overall survival, and the patients will additionally be assessed for progression-free survival, tumour response, and pharmacokinetic parameters. Final data from the study is expected by late 2012.

“The design of this trial has been well received and I am pleased to see that we were able to complete enrolment so quickly,” said John Ryan, Ph.D., MD, chair of the Medical Advisory Board of Cerulean. “I also am pleased that, on the heels of this milestone, we are exploring the breadth of the CRLX101 opportunity by initiating additional studies in high priority target indications.”

CRLX101 is an investigational anti-cancer agent that is a dual inhibitor of topoisomerase 1 and hypoxia-inducible factor-1 alpha. CRLX101 is a dynamically tumor-targeted nanopharmaceutical designed to concentrate in tumours, prolonging drug exposure at the site of action. Significant anti-tumour activity has been observed across a wide range of cancers in animal models. CRLX101 is currently in phase II clinical development.

Cerulean Pharma Inc. is a clinical-stage company specializing in the development of dynamically tumour-targeted nanopharmaceuticals.