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

Monday, December 15, 2008 General News
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SAN DIEGO, Dec. 15 Cylene Pharmaceuticals today announcedthe initiation of a Phase II clinical trial of quarfloxin (CX-3543) inpatients with carcinoid/neuroendocrine tumors (C/NET), which are malignantcancers arising from neural crest cells.

"Quarfloxin (CX-3543) is a small molecule that disrupts a protein:rDNAcomplex that forms in the abnormal nucleoli of cancer cells, therebyselectively inducing apoptotic cell death in cancers," said Dr. William Rice,President and Chief Executive Officer of Cylene Pharmaceuticals. "Manycommercialized cancer therapeutics act on or through the nucleolus, butquarfloxin is the first agent designed to directly target a key functionwithin the nucleolus. Quarfloxin has been well tolerated in humans and hasdemonstrated signs of biological benefit for patients with C/NET in Phase Iclinical trials. Moreover, biodistribution studies revealed that quarfloxinaccumulates in the tissues in which C/NET arise."

In this open-label Phase II trial, quarfloxin will be administered topatients with low or intermediate grade C/NET, including those receivingconcomitant treatment with a stable dose of octreotide. This multi-centeredstudy will include an assessment of improvements in patients' symptoms andbiochemical markers, in addition to RECIST tumor response measurements. Thefirst patient was enrolled and treated at Front Range Cancer Specialists inFort Collins, CO under the care of Robert Marschke Jr., M.D. This study isexpected to enroll up to 25 patients at several leading cancer centers.

"The initiation of this Phase II trial with quarfloxin is a majormilestone for Cylene, but more importantly, we hope that quarfloxin will be aneffective treatment for cancer patients with limited therapeuticalternatives," added Dr. Daniel Von Hoff, Cylene's Co-Founder and VicePresident, Medical Affairs. "Quarfloxin has demonstrated potent in vivoefficacy against a broad range of tumors and a considerable therapeutic windowin preclinical antitumor models, and has a unique profile of concentrating inneural crest tissues. For these reasons, we are enthusiastic about offering aPhase II clinical trial for patients with carcinoid/neuroendocrine tumors."

About Quarfloxin (CX-3543), a Nucleolus Targeting Agent (NTA)

Quarfloxin is a ground-breaking small-molecule targeted cancer therapeuticderived from the validated fluoroquinolone class of drugs. Rationally designedto selectively inhibit ribosomal RNA (rRNA) biogenesis in cancer cells,quarfloxin disrupts the interaction between the Nucleolin protein and aG-quadruplex DNA structure in the ribosomal DNA (rDNA) template, a criticalinteraction for rRNA biogenesis and one that is amplified in cancer cells. Asa result, quarfloxin selectively induces apoptotic cell death in cancers. Manycommercialized cancer therapeutics act indirectly on rRNA Biogenesis throughupstream modulators, but quarfloxin is the first agent to directly target thiscancer-specific aberrant cell function.

About Cylene Pharmaceuticals, Inc.

Cylene Pharmaceuticals is a biotech pharmaceutical company dedicated tothe discovery, development and commercialization of targeted small-moleculedrugs to treat life-threatening cancers. Cylene has created a diverseportfolio of product candidates, including novel inhibitors of cancer-linkedserine/threonine kinases, as well as innovative Nucleolus Targeting Agents(NTAs) that target the abnormal nucleolus functions of cancer cells andselectively kill cancer cells. More information can be found athttp://www.cylenepharma.com.

Cylene cautions you that statements included in this press release thatare not a description of historical facts, including implied statementsrelating to future outcomes of clinical trials, may be forward-lookingstatements that are subject to risks and uncertainties. Actual results maydiffer materially from those set forth in this release due to the risks anduncertainties inherent in Cylene's business including, without limitation,risks related to difficulties or delays in, testing, obtaining regulatoryapproval for, producing and marketing its products; unexpected adverse sideeffects or inadequate therapeutic efficacy of its products that could delay orprevent product development or commercialization, the scope and validity ofpatent protection for its products; competition from other pharmaceutical orbiotechnology companies; and its ability to obtain additional financing tosupport its operations. All forward-looking statements are qualified in theirentirety by this cautionary statement and Cylene undertakes no obligation torevise or update this news release to reflect events or circumstances afterthe date hereof.

SOURCE Cylene Pharmaceuticals


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