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Cyclacel Presents Updated Survival Data From the Pilot Study and Lead-In Phase of Seamless Phase 3 Study at the 2012 ASH Annual

Cyclacel Presents Updated Survival Data From the Pilot Study and Lead-In Phase
of Seamless Phase 3 Study at the 2012 ASH Annual Meeting

Median Overall Survival is 238 days, or Approximately 8 Months, and 1-Year
Survival is 35% With an Overall Response Rate of 41% in Elderly Patients With
Newly Diagnosed AML

BERKELEY HEIGHTS, N.J., Dec. 10, 2012 (GLOBE NEWSWIRE) -- Cyclacel
Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) (Cyclacel or the Company),
a biopharmaceutical company developing oral therapies that target the various
phases of cell cycle control for the treatment of cancer and other serious
disorders, announced updated survival data from the pilot study and lead-in
phase of SEAMLESS, the Company's randomized, Phase 3, registration-directed
study of oral sapacitabine capsules in elderly patients aged 70 years or older
with newly diagnosed acute myeloid leukemia (AML) who are not candidates for,
or have refused, induction chemotherapy. The data were reported at a poster
presentation at the 54^th Annual Meeting of the American Society of Hematology
(ASH) in Atlanta, Georgia.

"The updated survival data of the sequential administration of sapacitabine
and decitabine is promising and provides support for the ongoing SEAMLESS
Phase 3 study in elderly patients with newly diagnosed AML," said Hagop
Kantarjian, M.D., Chairman & Professor, Department of Leukemia, The University
of Texas MD Anderson Cancer Center and chair of the SEAMLESS study. "Intensive
chemotherapy does not benefit most AML patients aged 70 years or older. Median
survival by intensive chemotherapy is only 4.6 months and is associated with a
4-week death rate of 26% and an 8-week death rate of 36%. We urgently need
better treatment regimens for this patient population."

Pooled Topline Results of the Pilot Phase 1/2 Study and Lead-In Stage of
SEAMLESS

Forty-six patients were treated with alternating cycles of sapacitabine and
decitabine, which is the treatment regimen in the experimental arm of
SEAMLESS. Median age is 77 years (range 70-90). Thirty-three patients (72%)
are 75 years or older. Median overall survival is 238 days, or approximately 8
months. The number of patients still alive at 3 months was 38 (83%), at 6
months 30 (65%), at 12 months 16 (35%) and at 18 months 12 (26%). Sixteen
patients (35%) survived 1 year or longer. Among 33 patients who are 75 years
or older, median overall survival is 263 days, or approximately 9 months, and
1-year survival is 36%. Nineteen patients (41%) responded with 10 complete
responses (CRs), 4 partial responses (PRs) and 5 major hematological
improvements (HIs). Median time to response is 2 cycles, i.e., one cycle of
decitabine and one cycle of sapacitabine (range 1-10). Twenty-seven patients
(59%) received 5 or more cycles of treatment. Two dose-limiting toxicities
(DLT) were observed (lung infection/sepsis, typhlitis). Thirty-day mortality
from all causes was 4%. Sixty-day mortality from all causes was 13% with one
death from typhlitis considered to be possibly related to decitabine by
investigator assessment. The sequential combination of decitabine and
sapacitabine is safe and active.

SEAMLESS Study Design

Sapacitabine (CYC682), an orally-available nucleoside analogue, is currently
being studied in SEAMLESS, an ongoing, Phase 3, registration-directed trial in
elderly patients aged 70 years or older with newly diagnosed AML who are not
candidates for or have refused induction chemotherapy. SEAMLESS is being
conducted under a Special Protocol Assessment (SPA) agreement that Cyclacel
reached with the U.S. Food and Drug Administration (FDA). Patients who
received hypomethylating agents for prior myelodysplastic syndromes or
myeloproliferative diseases are excluded from SEAMLESS. Patients in the
control arm of SEAMLESS will receive decitabine alone, while in the
experimental arm of SEAMLESS, patients will receive intravenous decitabine at
20 mg/m2 per day for five consecutive days of a 4-week cycle (odd cycles)
alternating with sapacitabine at 300 mg orally twice per day for three days
per week for two weeks of a 4-week cycle (even cycles). The primary efficacy
endpoint is overall survival. A prespecified interim analysis for futility
will be performed and reviewed by the Data Safety Monitoring Board.

Publication details

54^th Annual Meeting of the American Society of Hematology (ASH)

Abstract:   2630
            Pooled analysis of elderly patients with newly diagnosed AML
Title:      treated with sapacitabine and decitabine administered in
            alternating cycles
Date/Time: Sunday, December 9, 2012, 6:00 PM – 8:00 PM Eastern Time
           Hall B1-B2, Level 1, Building B (Georgia World Congress Center)
Session:   615. Acute Myeloid Leukemia – Therapy, excluding Transplantation:
            Poster II

The abstract is available online through the annual meeting section of the
American Society of Hematology's website at
http://www.hematology.org/Meetings/Annual-Meeting/.

About Acute Myeloid Leukemia (AML)

AML is a cancer of the blood cells that progresses rapidly and if not treated,
could be fatal in a few months. AML is generally a disease of older people and
is uncommon before the age of 40. The average age of a patient with AML is
about 67 years. There are more than 12,300 new cases of AML, of which about
half are elderly aged 70 years or older. Nearly 9,000 deaths are caused by
this cancer each year in the United States. A review of The University of
Texas MD Anderson Cancer Center's historical experience with front-line
intensive induction chemotherapy for AML patients aged 70 years or older
demonstrated that while 45% achieved a complete remission, median overall
survival was only 4.6 months and was associated with a 4-week death rate of
26% and a 8-week death rate of 36% (Kantarjian, H, et al, Blood,
doi:10.1182/blood-2010-03-276485).

About Sapacitabine

Sapacitabine (CYC682), an orally-available nucleoside analogue, is currently
being studied in an ongoing, Phase 3, registration-directed trial in elderly
patients aged 70 years or older with newly diagnosed AML who are not
candidates for or have refused induction chemotherapy. Sapacitabine is also
the subject of Phase 2 trials in patients with hematological malignancies,
including AML, myelodysplastic syndromes (MDS), cutaneous T-cell lymphoma
(CTCL), chronic lymphocytic leukemia and small lymphocytic lymphoma, and
non-small cell lung cancer (NSCLC), and a Phase 1 trial in combination with
seliciclib in patients with advanced solid tumors. Sapacitabine acts through a
novel DNA single-strand breaking mechanism, leading to production of DNA
double strand breaks (DSBs) and/or checkpoint activation. Unrepaired DSBs
cause cell death. Repair of sapacitabine-induced DSBs is dependent on the
homologous recombination DNA repair (HRR) pathway. Both sapacitabine and
CNDAC, its major metabolite, have demonstrated potent anti-tumor activity in
preclinical studies.

Over 500 patients have received sapacitabine in Phase 2 studies in AML, MDS,
CTCL and NSCLC and Phase 1 studies in hematological malignancies and solid
tumors. Results from a randomized Phase 2, single-agent study of
sapacitabine, including promising 1-year survival in elderly patients with AML
aged 70 years or older, were published in The Lancet Oncology in November
2012. At the 2011 ASH Annual Meeting, Cyclacel reported data from a pilot
Phase 1/2 study including promising response rate, overall survival and low
4-week and 8-week mortality in elderly patients with AML aged 70 years or
older receiving sapacitabine alternating with decitabine. The FDA and the
European Medicines Agency have designated sapacitabine as an orphan drug for
the treatment of both AML and MDS. Sapacitabine is part of Cyclacel's
pipeline of small molecule drugs designed to target and stop uncontrolled cell
division.

About Cyclacel Pharmaceuticals, Inc.

Cyclacel is a biopharmaceutical company developing oral therapies that target
the various phases of cell cycle control for the treatment of cancer and other
serious diseases. The Company's most advanced oral product candidate,
sapacitabine, is the subject of SEAMLESS, a Phase 3 trial being conducted
under an SPA with the FDA as front-line treatment of acute myeloid leukemia
(AML) in the elderly and Phase 2 studies for AML, myelodysplastic syndromes
(MDS), chronic lymphocytic leukemia (CLL) and solid tumors including breast,
lung, ovarian and pancreatic cancer.Cyclacel's pipeline includes seliciclib,
a CDK inhibitor, in Phase 2 for lung and nasopharyngeal cancer and in Phase 1
in combination with sapacitabine; and CYC065, a second generation CDK
inhibitor, in IND-directed development. Cyclacel's strategy is to build a
diversified biopharmaceutical business focused in hematology and oncology
based on a development pipeline of novel drug candidates. Please visit
www.cyclacel.com for additional information.

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 2012 Cyclacel Pharmaceuticals, Inc.All Rights Reserved.The
Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.

CONTACT: Investors/Media:
         Corey Sohmer
         (908) 517-7330
         csohmer@cyclacel.com