Cerulean’s second candidate from its clinically validated platform, CRLX301, a tubulin inhibitor, capitalizes on the strengths of its payload, docetaxel. Docetaxel, while being one of the most important cancer therapies developed, has significant side effects. Non-clinical data has demonstrated that Cerulean’s nanopharmaceutical platform has the potential to dramatically improve both the safety and effectiveness of docetaxel, while enabling therapeutic benefits in multi-drug resistant tumor models where docetaxel has previously exhibited little activity. CRLX301 has a substantial market opportunity and relatively low risk because it is the marriage of a highly successful, commercially validated payload and a clinically validated platform.
Clinical development program
In the first half of 2014, Cerulean will commence a Phase 1 clinical trial to assess the safety of CRLX301. The goal of the trial will be to determine maximum tolerated dose and dose regimen for CRLX301.