Cerulean Pharma Inc., a leader in developing dynamically tumor-targeted nanopharmaceuticals, today announced that it has completed enrollment of a randomized Phase 2 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 tumor type.
"Completing enrollment of our Phase 2 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 1 and Phase 2a 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 2 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, tumor 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 enrollment so quickly," said John Ryan, Ph.D., M.D., 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."
Cerulean Pharma Inc.