Cylene Pharmaceuticals has initiated
a single-agent Phase II clinical trial of its lead Ribosomal RNA Biogenesis
Inhibitor, quarfloxin (CX-3543), in patients with chronic lymphocytic
leukemia (CLL), a cancer of the white blood cells and bone marrow.
Quarfloxin (CX-3543) is a small molecule that selectively targets a DNA
protein complex that is amplified in cancer cells, leading to inhibition of
ribosomal RNA biogenesis and induction of apoptotic cell death. In vitro
tests have shown CLL cells taken from patients to be very sensitive to the
apoptotic effects of Quarfloxin. In this open-label trial, CX-3543 will be
administered to patients with CLL whose leukemia has progressed on prior
treatment with a purine analog and a monoclonal antibody. This study is
expected to enroll up to 25 patients at several leading cancer centers,
including the Tower Oncology Group in Los Angeles, California, South Texas
Accelerated Research Therapeutics (START) in San Antonio, Texas, and the
Mayo Clinic Arizona in Scottsdale, Arizona.
"We are very pleased with the progress of our proprietary Ribosomal RNA
Biogenesis Inhibition program. The initiation of the Company's first Phase
II trial with our lead molecule is an important milestone for Cylene," said
Dr. William Rice, President and Chief Executive Officer of Cylene
Pharmaceuticals.
"Because quarfloxin has demonstrated potent in vivo efficacy against a
broad range of tumors and a considerable therapeutic window in animal
xenograft models, we also plan on initiating additional Phase II studies in
other cancer indications," added Dr. Daniel Von Hoff, Cylene's Co-Founder
and Vice President, Medical Affairs. "Moreover, quarfloxin appears to have
promise in combination with other compounds, and it has been well-tolerated
in patients with no substantial toxicities."
About Quarfloxin (CX-3543), a Ribosomal RNA Biogenesis Inhibitor (RBI)
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 pharmaceutical company dedicated to the
discovery, development and commercialization of targeted small-molecule
drugs to treat life-threatening cancers. Using its proprietary Ribosomal
RNA Biogenesis Inhibition Technology (RABIT(TM)) to design molecules that
combat drug-resistant forms of cancer, Cylene has created multiple product
candidates in different stages of development. Cylene's most advanced
cancer agent, Quarfloxin (CX-3543), is a Ribosomal RNA Biogenesis Inhibitor
(RBI) in Phase II clinical development in chronic lymphocytic leukemia and
late-stage Phase I development in solid tumors. More information can be
found at cylenepharma.
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.
Cylene Pharmaceuticals
cylenepharma