July 12, 2011 - Cerulean Pharma Inc., a leader in designing and developing tumor-targeted nanopharmaceuticals, announced the dosing of the first patients with CRLX101 in a randomized, controlled non-small cell lung cancer (NSCLC) Phase 2 clinical trial.The initiation of this Phase 2 study marks a major milestone in the clinical advancement of nanopharmaceuticals,” said Oliver Fetzer, Ph.D., president and chief executive officer of Cerulean. “Cerulean is excited to develop CRLX101 as a potential new therapy for lung cancer patients who otherwise have limited treatment options.”
The primary objective of the Phase 2 study is to assess the efficacy and safety of CRLX101 in advanced NSCLC patients whose disease has progressed following one or two prior regimens of therapy. Approximately 150 patients are anticipated to be enrolled in this study at 26 clinical trial sites in Russia and Ukraine. Patients will be randomized 2:1 to receive either CRLX101 plus best supportive care or best supportive care, respectively. Patients will be evaluated for overall survival, progression-free survival, tumor response, and pharmacokinetic parameters... [PDF] Cerulean Pharma's Press Release -
