Cerulean initiates CRLX101 Phase 2 trial in non-small cell lung cancer

Jul 13 2011

Cerulean Pharma Inc., a leader in designing and developing tumor-targeted nanopharmaceuticals, today 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.

"Cerulean is a leading developer of cancer-focused nanopharmaceuticals and I am thrilled to advance this tumor-targeted agent into Phase 2 development," said Edward Garmey, M.D., chief medical officer of Cerulean. "Based on exciting preclinical and clinical data, CRLX101 has the potential to be effective in both squamous and non-squamous histology patient populations, as well as in patients with a variety of tumor mutational markers including KRAS and EGFR. There may exist, therefore, the opportunity to consolidate rather than further divide the treatment landscape in lung cancer, while improving safety and quality-of-life parameters."