Cyclacel Pharmaceuticals, Inc.: Press release

BERKELEY HEIGHTS, N.J. and DUNDEE, United Kingdom, 2012-11-05 13:00 CET (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 diseases, announced today the award of a grant of approximately £1.2
($1.9) million from the UK Government's Biomedical Catalyst to complete
IND-directed preclinical development of CYC065, its novel, orally available,
second generation, cyclin-dependent kinase (CDK) inhibitor. 

"For over a decade Cyclacel has been a leader in the study of cell cycle
biology and the identification of novel anticancer drugs that exploit
mechanisms of cell cycle control" said Spiro Rombotis, Cyclacel's President &
Chief Executive Officer. "The Biomedical Catalyst award recognizes the
scientific excellence of our Company's researchers. The grant will allow us to
explore CYC065's promising anticancer activity in a translational biology
program targeting specific leukemia and other cancer disease pathways with the
ultimate goal of filing for regulatory approval to begin clinical trials. If
successful, the program will provide the basis for stratified clinical
development of CYC065 or treating patients with cancers that match the genetic
mechanism targeted by the drug. CYC065 is part of Cyclacel's deep pipeline of
novel medicines designed to target and stop uncontrolled cell division, led by
sapacitabine, an orally-available nucleoside analogue currently in a pivotal
Phase 3 trial in elderly patients with acute myeloid leukemia (AML)." 

The project aims to complete IND-directed preclinical development of CYC065 and
following regulatory clearance enable first-in-humans Phase 1 clinical studies.
A key component of the project is a translational biology effort which may lead
to validating one or more patient stratification biomarkers. Such biomarkers
will be used to inform clinical development of CYC065 and direct its
administration to patient groups most likely to benefit from the drug's
mechanism. 

There is a strong preclinical rationale for the use of CYC065 as a stratified
medicine, or matching the treatment with tumor genetics and other disease
features selected on the basis of clinical biomarkers, for orphan diseases with
a high unmet medical need, including certain adult, infant and pediatric
leukemias. In particular, CYC065 has been shown to target key components of
leukemogenic and survival pathways in acute leukemias, including the MCL1
anti-apoptotic protein, and also transcription, driven by the rearranged MLL or
mixed lineage leukemia gene. 

About CYC065

CYC065 is a novel, orally available, cell cycle kinase inhibitor currently in
IND-directed preclinical development. CYC065 targets similar CDK/cyclin
complexes to those targeted by seliciclib, Cyclacel's first generation CDK
inhibitor currently in Phase 2 studies. CYC065 retains the high CDK specificity
of seliciclib, but with substantially higher anti-proliferative potency and
improved pharmaceutical properties. CYC065 is a second generation aminopurine
which selectively inhibits CDK2, CDK5 and CDK9.  Strong preclinical anti-cancer
efficacy data for CYC065 in multiple myeloma, chronic lymphocytic leukemia
(CLL) and mixed lineage leukemia (MLL) have been presented at the 2010 Annual
Meetings of the American Society of Hematology (ASH) 1 and the American
Association of Cancer Research (AACR). 2 3 At the 2010 AACR CYC065 was also
reported to be active in solid tumor models, including trastuzumab-resistant,
cyclin E overexpressing breast cancer. These findings were subsequently
published by Scaltriti, et al ("Cyclin E amplification/overexpression is a
mechanism of trastuzumab resistance in HER2+ breast cancer patients", PNAS,
2011:108:3761-3766). In addition CYC065 was shown to have preclinical efficacy
in proliferative kidney disease models (Cyclacel data on file).  Cyclacel
discovered CYC065 in collaboration with the Cancer Research UK Centre for
Cancer Therapeutics at The Institute of Cancer Research. 

About CDKs and Cyclins

The discovery of CDKs, cyclins and their mechanisms of action were the subject
of the 2001 Nobel Prize for Medicine and Physiology. Cyclin-dependent kinases
(CDKs) are a group of signaling molecules that play a direct role in the
regulation and progression of the cell cycle, a biological mechanism which in
healthy humans regulates uncontrolled cell division. In people with cancer,
cell cycle control mechanisms malfunction resulting in proliferation and
disease progression. CDK activity is dependent on association with their
regulatory subunits called cyclins. Production and destruction of cyclins are
tightly regulated in coordination with cell cycle progression. Targeting
CDK/cyclin complexes is an attractive strategy for the design of novel
anticancer drugs. 

About MLL Leukemias

MLL or mixed lineage leukemia is an aggressive cancer of the blood associated
with chromosomal rearrangements of the MLL gene. MLL is predominantly a
children's disease with poor prognosis despite treatment. Five year survival is
less than 50%.  MLL leukemia occurs in 5% of adult acute myeloid leukemia or
AML, 15-20% of pediatric AML, 10% of therapy-related AML, and 22% of acute
lymphoblastic leukemia or ALL of which 50% occurs in infants aged less than 1. 
There are no approved therapies for MLL leukemia.  The MLL gene encodes a
histone methyltransferase enzyme that is thought to regulate how genes
transcribe DNA.  MLL was first reported to span the breakpoint in 11q23
chromosomal translocations associated with human leukemias in 1991. 4 

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. Sapacitabine oral capsules is in the SEAMLESS Phase 3 trial
being conducted under an SPA with the FDA as front-line treatment of acute
myeloid leukemia (AML) in the elderly, 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 oral capsules, 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. 

About The Biomedical Catalyst

The Biomedical Catalyst, announced by UK Prime Minister David Cameron in
December 2011, is a programme of public funding designed to deliver growth to
the UK life sciences sector. Delivered jointly by the Medical Research Council
and the Technology Strategy Board, the Biomedical Catalyst provides responsive
and effective support for the best life science opportunities arising in the
UK. The programme is open to UK academics and small and medium enterprises
(SMEs) and seeks to support those opportunities which demonstrate the highest
scientific and commercial potential, irrespective of medical area. For further
information please visit:
http://www.innovateuk.org/content/competition/biomedical-catalyst.ashx 

The Technology Strategy Board is the UK government's innovation agency. Its
goal is to accelerate economic growth by stimulating and supporting
business-led innovation. Sponsored by the Department for Business, Innovation
and Skills (BIS), the Technology Strategy Board brings together business,
research and the public sector, supporting and accelerating the development of
innovative products and services to meet market needs, tackle major societal
challenges and help build the future economy. For more information please visit
www.innovateuk.org. 

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. 

1 Pozzi S et al. CYC065, a potent derivative of seliciclib, is active in
multiple myeloma in preclinical studies. 52nd Annual Meeting of American
Society of Hematology, 2010, Abstract 2999 

2 Chen R et al. A novel derivative of the CDK inhibitor roscovitine that
induces apoptosis in CLL and overcomes stromal cell-mediated protection.
Proceedings of the 101st Annual Meeting of the American Association for Cancer
Research; 2010, Abstract 4431. 

3 Frame S et al. Therapeutic potential of CDK inhibitors in MLL leukemias.
Proceedings of the 101st Annual Meeting of the American Association for Cancer
Research; 2010, Abstract 3886. 

4 Ziemin-vd Poel, et al, Proc Natl Acad Sci U S A. 1991 December 1; 88 (23):
10735–10739. 

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