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Cylene Pharmaceuticals Initiates Phase II Clinical Trial of Quarfloxin (CX-3543) in Patients With Carcinoid/Neuroendocrine Tumors
Date:12/15/2008

SAN DIEGO, Dec. 15 /PRNewswire/ -- Cylene Pharmaceuticals today announced the initiation of a Phase II clinical trial of quarfloxin (CX-3543) in patients with carcinoid/neuroendocrine tumors (C/NET), which are malignant cancers arising from neural crest cells.

"Quarfloxin (CX-3543) 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," said Dr. William Rice, President and Chief Executive Officer of Cylene Pharmaceuticals. "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."

In this open-label Phase II trial, quarfloxin will be administered to patients with low or intermediate grade 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. The first patient was enrolled and treated at Front Range Cancer Specialists in Fort Collins, CO under the care of Robert Marschke Jr., M.D. This study is expected to enroll up to 25 patients at several leading cancer centers.

"The initiation of this Phase II trial with quarfloxin is a major milestone for Cylene, but more importantly, we hope that quarfloxin will be an effective treatment for cancer patients with limited therapeutic alternatives," added Dr. Daniel Von Hoff, Cylene's Co-Founder and Vice President, Medical Affairs. "Quarfloxin has demonstrated potent in vivo efficacy agai
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