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Cyclacel Announces Grants of New U.S. & European Patents Covering Sapacitabine Used in Combination With HDAC Inhibitors



Cyclacel Announces Grants of New U.S. & European Patents Covering Sapacitabine
Used in Combination With HDAC Inhibitors

Granted Patents Provide Exclusivity for Potential Uses of Sapacitabine in
Hematological Malignancies and Solid Tumors

BERKELEY HEIGHTS, N.J., Feb. 12, 2013 (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, today announced the issuance of U.S. Patent No. US 8,349,792 ('792)
and European Patent No 2,101,790 ('790). Both patents include claims to
combination treatment of sapacitabine, the Company's lead product candidate,
with HDAC (histone deacetylase) inhibitors. The patents provide exclusivity
until June 2029 and December 2027 respectively.

"The grants of the '792 and '790 patents are important enhancements of
sapacitabine's intellectual property estate. They supplement sapacitabine's
existing composition of matter, dosing regimen and combination treatment
patent protection and support US and EU market exclusivity toward the end of
the next decade," said Spiro Rombotis, President and Chief Executive Officer
of Cyclacel. "We are pursuing a broad intellectual property strategy providing
us with a strong foundation to achieve our clinical and commercial objectives
for sapacitabine and our other assets. As we continue to enroll SEAMLESS, our
pivotal Phase 3 trial of sapacitabine as front-line treatment in elderly
patients with acute myeloid leukemia (AML), we look forward to providing
additional updates for sapacitabine this year, including Phase 2 data in
myelodysplastic syndromes (MDS), AML preceded by MDS, and solid tumors."

The two patents include claims to combinations of sapacitabine and HDAC
inhibitors, pharmaceutical compositions comprising sapacitabine and HDAC
inhibitors, and methods of treatment using such compositions of proliferative
disorders including leukemias, lymphomas, and lung cancer. HDAC inhibitors
specifically claimed include belinostat (PXD101), dacinostat (LAQ824),
entinostat (MS-275), mocetinostat (MGCD0103), pracinostat (SB939), romidepsin
(depsipeptide), sodium butyrate, sodium valproate, tacedinaline (CI-994,
PD-123654, GOE-5549, acetyldinaline), trichostatin A, vorinostat (SAHA or
suberoylanilide hydramic acid), and valproic acid. Cyclacel published
preclinical model data in 2010 demonstrating that sapacitabine works
synergistically with histone deacetylase (HDAC) inhibitors to induce
significant reductions in tumor cell growth in vitro and in vivo.

The claims and specifications of the '792 and '790 patents are unrelated to
the claims and specifications of the four Cyclacel-owned patents that are the
subject of Cyclacel's intellectual property litigation with Celgene
Corporation (Celgene) regarding Celgene's drug romidepsin (depsipeptide,
Istodax®).

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. Data, discussed at two separate sessions at The Eighth Annual
Hematologic Malignancies 2012 Conference, from an ongoing, multicenter, phase
2 randomized trial of single-agent oral sapacitabine capsules in older
patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS)
after treatment failure of front-line hypomethylating agents, such as
azacitidine (Vidaza®) and/or decitabine (Dacogen®), showed sapacitabine nearly
doubles expected survival of elderly patients with MDS after front-line
therapy failure. 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 2012 ASH Annual Meeting, Cyclacel reported data from the pilot
study and lead-in phase of SEAMLESS including promising response rate, overall
survival and low 30-day and 60-day 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 2013 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The
Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.
Istodax® and Vidaza® are registered trademarks of Celgene Corporation.
Dacogen® is a registered trademark used by Eisai Inc. under license from Astex
Pharmaceuticals, Inc.

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