In this open-label Phase II trial, quarfloxin will be administered to patients with low or intermediate grade carcinoid/neuroendocrine tumors (C/NET), including those receiving concomitant treatment with a stable dose of octreotide.
This multi-centered study will include an assessment of improvements in patients’ symptoms and biochemical markers, in addition to Recist tumor response measurements. This study is expected to enroll up to 25 patients at several cancer centers.
William Rice, president and CEO of Cylene Pharmaceuticals, said: “Quarfloxin is a small molecule that disrupts a protein:rDNA complex that forms in the abnormal nucleoli of cancer cells, thereby selectively inducing apoptotic cell death in cancers. Many commercialized cancer therapeutics act on or through the nucleolus, but quarfloxin is the first agent designed to directly target a key function within the nucleolus.
“Quarfloxin has been well tolerated in humans and has demonstrated signs of biological benefit for patients with C/NET in Phase I clinical trials. Moreover, biodistribution studies revealed that quarfloxin accumulates in the tissues in which C/NET arise.”