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Cyclacel Pharmaceuticals, Inc. CYCLACEL PHARMACEUTICALS AND MD ANDERSON CANCER CENTER ANNOUNCE STRATEGIC ALLIANCE TO STUDY NOVEL CYCLACEL MEDICINES IN HEMATOLOGICAL MALIGNANCIES - Multi-product agreement builds on long-t

Key Takeaway: CYCLACEL PHARMACEUTICALS AND MD ANDERSON CANCER CENTER ANNOUNCE STRATEGIC ALLIANCE TO STUDY NOVEL CYCLACEL MEDICINES IN HEMATOLOGICAL - Multi-product agreement builds on long-term clinical collaboration in hematological malignancies- Berkeley Heights, NJ and Houston, TX, Octob

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CYCLACEL PHARMACEUTICALS AND MD ANDERSON CANCER CENTER ANNOUNCE STRATEGIC ALLIANCE TO STUDY NOVEL CYCLACEL MEDICINES IN HEMATOLOGICAL
- Multi-product agreement builds on
long-term clinical collaboration in hematological malignancies-
Berkeley Heights, NJ and Houston, TX, October
4, 2018 - 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 leukemia 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.
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).
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.
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.
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.
Company: Paul McBarron, (908) 517-7330, pmcbarron@cyclacel.com
Investor Relations: Russo Partners LLC, Alexander Fudukidis, (646) 942-5632, alex.fudukidis@russopartnersllc.com
MD Anderson Contact: 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.
Last updated: Oct 4, 2018