Cerulean Pharma Inc., a leader in designing and developing tumour-targeted nano-pharmaceuticals, announced the dosing of the first patients with CRLX101 in a randomized, controlled Non-Small Cell Lung Cancer (NSCLC) phase II clinical trial.

“The initiation of this phase II study marks a major milestone in the clinical advancement of nanopharmaceuticals,” said Oliver Fetzer, PhD, 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” he added.

The primary objective of the phase II 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, tumour response, and pharmacokinetic parameters.

“Cerulean is a leading developer of cancer-focused nano-pharmaceuticals and I am thrilled to advance this tumour-targeted agent into phase II development,” said Edward Garmey, MD, 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 tumour 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.”

CRLX101 is a tumour-targeted nano-pharmaceutical containing camptothecin, an inhibitor of both topoisomerase 1 and hypoxia-inducible factor-1 alpha (HIF-1). CRLX101 is designed to concentrate in tumour tissue and tumour cells, prolonging drug exposure at the site of action. CRLX101 has demonstrated significant anti-tumour activity across a wide range of cancers in animal models and has been well tolerated in a recent 36 patient phase II a solid tumour clinical trial. It is currently in phase II clinical development.