Cyclacel's Seliciclib to be Evaluated in Investigator-Initiated Clinical Study
to Treat Rheumatoid Arthritis
Study Supported by Approximately $1.5 Million Grant From UK Medical Research
BERKELEY HEIGHTS, N.J. and DUNDEE, UK, Aug. 12, 2013 (GLOBE NEWSWIRE) --
Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) (Cyclacel or the
Company), today announced that scientists at Newcastle University have been
awarded £1 million (approximately $1.5 million) by the UK's Medical Research
Council for a clinical trial to evaluate whether seliciclib, Cyclacel's oral
cyclin dependent kinase (CDK) inhibitor currently in clinical development to
treat certain cancers, can be repurposed to treat rheumatoid arthritis (RA) in
patients who do not respond to existing treatments. Seliciclib may work for RA
by targeting proliferating fibroblasts, a different type of approach than
conventional RA therapies, and could therefore succeed where these treatments
"Repurposing of drugs is a powerful way of bridging the gap between early
stage research and development of new treatments," said Professor John Isaacs,
Director of the Institute of Cellular Medicine at Newcastle University and
lead investigator. "Compared with traditional drug discovery approaches, this
is a considerably quicker route to the clinic because it leapfrogs the early
stages of drug development. If our trial with seliciclib proves successful, it
could dramatically improve treatment outcomes for patients with rheumatoid
Over the past 20 years, improved treatment strategies and better drugs have
resulted in greatly improved outcomes for patients. Currently available drugs
for RA, called disease-modifying antirheumatic drugs (DMARDs), slow or halt
the progress of the disease by reducing joint inflammation or neutralizing
immune cells. However, many patients still do not recover and about one in ten
do not respond at all to conventional treatments.
Scientists believe that another type of cell, fibroblasts, may be responsible
and may be limiting response to conventional treatments. In RA these cells
divide uncontrollably and produce chemicals that eat into cartilage and bone
and cause inflammation.
Using Seliciclib to Target Fibroblasts
The Newcastle team, with collaborators at the Universities of Birmingham and
Glasgow, believe that seliciclib may reduce or stop abnormal fibroblast
activity. Seliciclib has been previously shown to selectively inhibit enzyme
targets which are central to the process of cell division and cell cycle
control thereby inhibiting cellular proliferation.
Seliciclib, an orally-available CDK2, -7 and -9 inhibitor, has been evaluated
to date in approximately 380 patients and is currently being explored in
combination with Cyclacel's orally-available sapacitabine in patients with
The researchers hope to show that seliciclib is safe and potentially effective
in patients with RA. The trail design, to be finalised with the funding
sponsor, will be a Phase 2 study treating patients who have had the condition
for at least a year and who are already taking treatment but not responding
well enough. If this is successful the study will continue to test seliciclib
in patients taking different treatments, at different stages of their illness.
About Rheumatoid Arthritis (RA)
RA is a condition in which the joints become inflamed and painful. It is
caused by the patient's immune system mistakenly attacking their joints. The
resulting inflammation reduces joint movement and eventually causes joint
damage and deformity. According to various estimates RA affects approximately
1.3 million adults in the US and 400,000 in the UK.
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, Cyclacel's most advanced product candidate, is
the subject of SEAMLESS, a Phase 3 trial being conducted under an SPA with the
FDA as front-line treatment for acute myeloid leukemia (AML) in the elderly,
and other studies for myelodysplastic syndromes (MDS), chronic lymphocytic
leukemia (CLL) and solid tumors including breast, lung, ovarian and pancreatic
cancer and in particular those carrying BRCA mutations. 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.
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 the Company's most recent
Annual Report on Form 10-K and other periodic and other filings Cyclacel files
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 Cyclacel assumes no obligation to update any forward-looking statements,
whether as a result of new information, future events or otherwise.
© Copyright 2013 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The
Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.
CONTACT: Cyclacel Pharmaceuticals, Inc.
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