Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP)
("Cyclacel" or the "Company"), today announced the publication of a
peer-reviewed journal article featuring the company’s cyclin
dependent kinase 2/9 (CDK2/9) inhibitors. In an article published
in the Journal of National Cancer Institute (JNCI), preclinical
data demonstrated that both Cyclacel’s CYC065, a second-generation,
clinical stage, CDK2/9 inhibitor, and CCT68127, a pre-clinical
stage CDK2/9 inhibitor, demonstrated prominent antitumor activity
against lung cancer through anaphase catastrophe, a novel, cancer
specific mechanism of action.
The Journal of National Cancer Institute article
entitled, "Next-Generation CDK2/9 Inhibitors and Anaphase
Catastrophe in Lung Cancer," demonstrates that CYC065 and CCT68127
cause multipolar anaphase and apoptosis in lung cancer cells with
supernumerary centrosomes, known as anaphase catastrophe. This
novel mechanism of action offers an innovative approach to combat
aneuploid cancer cells which contain abnormal numbers of
chromosomes. Aneuploidy is a hallmark for cancer development and
occurs in virtually every cancer, but is particularly found in lung
cancer. Approximately 90 percent of cancer cells in solid tumors
and blood cancer are aneuploid.
The article further reported that inhibition of
CDK2 was the key mechanism of action and, as a consequence, lung
cancer cells underwent apoptosis or cell suicide by induction of a
novel mechanism called anaphase catastrophe. Similarly to a
previous report on seliciclib (Cyclacel’s first generation CDK
inhibitor), lung cancer cells with mutant KRAS were particularly
sensitive to CYC065 and CCT68127. Combination of CCT68127 with the
MEK inhibitor, trametinib, was synergistic. An efficacy study in
syngeneic cancer models of lung cancer with mutant KRAS
demonstrated tumor growth inhibitory effect and a significant
decrease of circulating tumor cells.
Citation: Kawakami M, Lisa, Mustachio M,
Rodriguez-Canales J, Mino B, Roszik J, Tong P, Wang J, J. Lee J,
Myung JH, Heymach JV, Johnson FM, Hong S, Zheng L, Hu S, Villalobos
PA, Behrens C, Wistuba I, Freemantle S, Liu X, Dmitrovsky E.
Next-Generation CDK2/9 Inhibitors and Anaphase Catastrophe in Lung
Cancer. J Natl Cancer Inst (2017) 109(6): djw297.
About CYC065
Cyclacel’s second generation CDK2/9 inhibitor,
CYC065, is being evaluated in an ongoing, first-in-human, Phase 1
trial in patients with advanced solid tumors. In addition to
determining safety and recommended dosing for Phase 2, the study
aims to investigate CYC065’s effects on the Mcl-1 biomarker, which
is implicated in the evolution of resistance in cancer. Evidence of
target engagement with prolonged Mcl-1 suppression in peripheral
blood cells was observed in patient samples from the study, as well
as decreases in kinase substrate phosphorylation and increases in
PARP cleavage, which were consistent with the Company’s preclinical
data. CYC065 is mechanistically similar but has much higher dose
potency, in vitro and in vivo, and improved metabolic stability
than seliciclib, Cyclacel's first generation CDK inhibitor.
Similar to palbociclib, the first CDK inhibitor approved by FDA in
2015, CYC065 may be most useful as a therapy for patients with both
liquid and solid tumors in combination with other anticancer
agents, including Bcl-2 antagonists, such as venetoclax, or HER2
inhibitors, such as trastuzumab.
About Cyclacel Pharmaceuticals,
Inc.
Cyclacel Pharmaceuticals is a clinical-stage
biopharmaceutical company using cell cycle, transcriptional
regulation and DNA damage response biology to develop innovative,
targeted medicines for cancer and other proliferative diseases.
Cyclacel's DNA damage response program is evaluating a sequential
regimen of sapacitabine and seliciclib, a CDK inhibitor, in
patients with BRCA positive, advanced solid cancers. The
transcriptional regulation program is evaluating CYC065, a CDK
inhibitor, in patients with advanced cancers. Cyclacel is analyzing
stratified and exploratory subgroups from a Phase 3 study of
sapacitabine in elderly patients with AML. Cyclacel's strategy is
to build a diversified biopharmaceutical business focused in
hematology and oncology based on a pipeline of novel drug
candidates. For additional information, please visit
www.cyclacel.com.
Forward-looking Statements
This news release contains certain forward-looking
statements that involve risks and uncertainties that could cause
actual results to be materially different from historical results
or from any future results expressed or implied by such
forward-looking statements. Such forward-looking statements include
statements regarding, among other things, the efficacy, safety and
intended utilization of Cyclacel's product candidates, the conduct
and results of future clinical trials, plans regarding regulatory
filings, future research and clinical trials and plans regarding
partnering activities. Factors that may cause actual results to
differ materially include the risk that product candidates that
appeared promising in early research and clinical trials do not
demonstrate safety and/or efficacy in larger-scale or later
clinical trials, trials may have difficulty enrolling, Cyclacel may
not obtain approval to market its product candidates, the risks
associated with reliance on outside financing to meet capital
requirements, and the risks associated with reliance on
collaborative partners for further clinical trials, development and
commercialization of product candidates. You are urged to consider
statements that include the words "may," "will," "would," "could,"
"should," "believes," "estimates," "projects," "potential,"
"expects," "plans," "anticipates," "intends," "continues,"
"forecast," "designed," "goal," or the negative of those words or
other comparable words to be uncertain and forward-looking. For a
further list and description of the risks and uncertainties the
Company faces, please refer to our most recent Annual Report on
Form 10-K and other periodic and other filings we file with the
Securities and Exchange Commission and are available at
www.sec.gov. Such forward-looking statements are current only as of
the date they are made, and we assume no obligation to update any
forward-looking statements, whether as a result of new information,
future events or otherwise.
© Copyright 2017 Cyclacel Pharmaceuticals, Inc. All
Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of
Cyclacel Pharmaceuticals, Inc.
Contacts
Company:
Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com
Investor Relations:
Russo Partners LLC, Alexander Fudukidis, (646) 942-5632, alex.fudukidis@russopartnersllc.com
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