Cylene Pharmaceuticals Initiates Phase II Clinical Trial of Quarfloxin (CX-3543) in Patients With Carcinoid/Neuroendocrine Tumors
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.
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
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.
President, Medical Affairs. “Quarfloxin has demonstrated potent in vivo
efficacy against a broad range of tumors and a considerable therapeutic window
in preclinical antitumor models, and has a unique profile of concentrating in
neural crest tissues. For these reasons, we are enthusiastic about offering a
Phase 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 therapeutic
derived from the validated fluoroquinolone class of drugs. Rationally designed
to selectively inhibit ribosomal RNA (rRNA) biogenesis in cancer cells,
quarfloxin disrupts the interaction between the Nucleolin protein and a
G-quadruplex DNA structure in the ribosomal DNA (rDNA) template, a critical
interaction for rRNA biogenesis and one that is amplified in cancer cells. As
a result, quarfloxin selectively induces apoptotic cell death in cancers. Many
commercialized cancer therapeutics act indirectly on rRNA Biogenesis through
upstream modulators, but quarfloxin is the first agent to directly target this
cancer-specific aberrant cell function.
About Cylene Pharmaceuticals, Inc.
Cylene Pharmaceuticals is a biotech pharmaceutical company dedicated to
the discovery, development and commercialization of targeted small-molecule
drugs to treat life-threatening cancers. Cylene has created a diverse
portfolio of product candidates, including novel inhibitors of cancer-linked
serine/threonine kinases, as well as innovative Nucleolus Targeting Agents
(NTAs) that target the abnormal nucleolus functions of cancer cells and
selectively kill cancer cells. More information can be found at
http://www.cylenepharma.com.
Cylene cautions you that statements included in this press release that
are not a description of historical facts, including implied statements
relating to future outcomes of clinical trials, may be forward-looking
statements that are subject to risks and uncertainties. Actual results may
differ materially from those set forth in this release due to the risks and
uncertainties inherent in Cylene’s business including, without limitation,
risks related to difficulties or delays in, testing, obtaining regulatory
approval for, producing and marketing its products; unexpected adverse side
effects or inadequate therapeutic efficacy of its products that could delay or
prevent product development or commercialization, the scope and validity of
patent protection for its products; competition from other pharmaceutical or
biotechnology companies; and its ability to obtain additional financing to
support its operations. All forward-looking statements are qualified in their
entirety by this cautionary statement and Cylene undertakes no obligation to
revise or update this news release to reflect events or circumstances after
the date hereof.
SOURCE Cylene Pharmaceuticals