Cyclacel Pharmaceuticals, Inc. (Nasdaq: CYCC, Nasdaq: CYCCP)
("Cyclacel" or the "Company"), a biopharmaceutical company
developing innovative medicines based on cancer cell biology, and
The University of Texas MD Anderson Cancer Center today announced a
three-year strategic alliance agreement that will enable clinical
evaluation for safety and efficacy of three Cyclacel medicines in
patients with hematological malignancies, including chronic
lymphocytic leukemia (CLL), acute myeloid leukemia (AML),
myelodysplastic syndrome (MDS) and other advanced leukemias.
MD Anderson will conduct four clinical studies with a total
projected enrollment of up to 170 patients, which will investigate
CYC065, CYC140 and sapacitabine either as single agents or in
combination with approved drugs. The collaboration leverages MD
Anderson’s expertise in clinical development of drugs for
hematological malignancies and Cyclacel’s novel drug portfolio that
is based on the Company’s knowledge of cell cycle biology and
mechanisms of cancer cell resistance to medicines.
“MD Anderson is committed to identifying and evaluating
innovative therapies to benefit patients with life-threatening
hematological malignancies,” said Hagop Kantarjian M.D., chair in
the Department of Leukemia at MD Anderson. “This alliance will
allow us to study three compounds in development that appear to
have promising preclinical and clinical data supporting their
further evaluation.”
“We are excited to expand our partnership with this alliance and
advance the clinical development of CYC065 (our lead program),
CYC140 and sapacitabine,” said Spiro Rombotis, President and Chief
Executive Officer of Cyclacel. “MD Anderson is forging novel
collaborative models to accelerate development of promising
therapies. The alliance will enable us to parallel track the
development of multiple Cyclacel drugs over the next three years
with the ultimate goal of benefiting patients with unmet medical
needs.”
Under the risk-sharing agreement MD Anderson will assume the
patient costs for all studies and Cyclacel, who is the sponsor,
will provide investigational drugs and other limited support. Upon
first commercial sale in specific indications studied in the
alliance, Cyclacel will make certain payments to MD Anderson.
The first study will be a Phase 1b trial evaluating a
combination of CYC065, a cyclin-dependent kinase (CDK2/9) inhibitor
with venetoclax, an approved drug targeting the Bcl-2 protein, in
patients with relapsed or refractory CLL. The second study
will be a Phase 1, first-in-human evaluation of CYC140, a Polo-like
kinase 1 (PLK1) inhibitor, in patients with advanced leukemias or
MDS. Both studies have received institutional review board (IRB)
approval. Two further protocols evaluating combinations of CYC065
and sapacitabine either as single agents or in combination with
approved agents are in development.
About Cyclacel Pharmaceuticals, Inc.
Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical
company using its expertise in cell cycle, transcriptional
regulation and DNA damage response biology in cancer cells to
develop innovative medicines. Cyclacel's transcriptional regulation
program is evaluating CYC065, a CDK inhibitor, in patients with
advanced cancers. The DNA damage response program is evaluating a
sequential regimen of sapacitabine and seliciclib, a CDK inhibitor,
in patients with BRCA positive, advanced solid cancers. CYC140, a
Polo-like-kinase 1 (PLK-1) inhibitor, is ready to start
investigation in cancer patients. 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.
About MD Anderson
The University of Texas MD Anderson Cancer Center in Houston
ranks as one of the world's most respected centers focused on
cancer patient care, research, education and prevention. The
institution’s sole mission is to end cancer for patients and their
families around the world. MD Anderson is one of only 49
comprehensive cancer centers designated by the National Cancer
Institute (NCI). MD Anderson is ranked No.1 for cancer care in U.S.
News & World Report’s “Best Hospitals” survey. It has ranked as
one of the nation’s top two hospitals for cancer care since the
survey began in 1990, and has ranked first 14 times in the last 17
years. MD Anderson receives a cancer center support grant from the
NCI of the National Institutes of Health (P30 CA016672).
About CYC065
CYC065, a second generation CDK2/9 inhibitor, has been evaluated
in a first-in-human, Phase 1 trial in patients with advanced solid
tumors and a recommended Phase 2 dose established. The study
demonstrated that CYC065 durably suppresses Mcl-1, a member of the
Bcl-2 family of survival proteins. CYC065 is under
investigation in combination with other anticancer drugs, including
Bcl-2 inhibitors such as venetoclax, or HER2 inhibitors such as
trastuzumab. Preclinical data show that CYC065 may benefit adults
and children with hematological malignancies, including acute
myeloid leukemias (AML), acute lymphocytic leukemias (ALL), and in
particular leukemias with rearrangement of the Mixed Lineage
Leukemia gene (MLL-r), chronic lymphocytic leukemias (CLL), B-cell
lymphomas, multiple myelomas, and patients with certain solid
tumors, including breast and uterine cancers, and
neuroblastomas.
About CYC140
CYC140 is a novel, small molecule, selective polo-like-kinase 1
(PLK1) inhibitor. CYC140 is differentiated from other PLK1
inhibitors, demonstrating potent and selective target inhibition
and high activity in xenograft models of human cancers when dosed
orally at non-toxic doses. CYC140 has completed IND-enabling
studies, funded by a grant of approximately $3.7 million from the
U.K. Government's Innovate UK, and is the subject of a
translational biology program focused on acute leukemias and
esophageal cancer.
About Sapacitabine
Sapacitabine (CYC682), an orally-available nucleoside analogue,
is currently being studied in an ongoing, extension of a Phase 1
study evaluating a combination regimen of sapacitabine and
seliciclib, a first generation CDK inhibitor. Parts 1 and 2 of the
study evaluated approximately 90 patients with advanced cancers.
Part 3 is ongoing in patients with BRCA positive, breast, ovarian
and pancreatic cancer. Over 1,000 patients with hematological
malignancies and solid tumors have received sapacitabine.
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.
Cyclacel
Contacts: |
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Company: |
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Paul McBarron, (908)
517-7330, pmcbarron@cyclacel.com |
Investor
Relations: |
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Russo Partners LLC,
Alexander Fudukidis, (646) 942-5632, |
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alex.fudukidis@russopartnersllc.com |
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MD Anderson
Contact: |
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Ron Gilmore, (713)
745-1898, rlgilmore1@mdanderson.org |
© Copyright 2018 Cyclacel Pharmaceuticals, Inc. All Rights
Reserved. The Cyclacel logo and Cyclacel® are trademarks of
Cyclacel Pharmaceuticals, Inc.
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