New US Patents Issued Covering Sapacitabine Use With Hypomethylating Agents
and Sapacitabine Dosing Regimens
Extend Exclusivity for Dosing Regimens Intended for Commercialization
BERKELEY HEIGHTS, N.J., Nov. 5, 2013 (GLOBE NEWSWIRE) -- Cyclacel
Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) (Cyclacel or the Company),
today announced that the US Patent and Trademark Office (USPTO) issued two
patents extending the exclusivity of sapacitabine, the Company's lead clinical
candidate. The first patent claims, among others, methods of treating cancer
comprising sapacitabine together with DNA methyltransferase inhibitors,
including azacitidine and decitabine.The second patent claims methods of use
for sapacitabine for the treatment of acute myeloid leukemia (AML) and
myelodysplastic syndromes (MDS), including the dosing regimen used in
SEAMLESS, the Company's ongoing, pivotal, registration-directed, Phase 3 study
in front-line elderly AML.
"The two new US patents are important enhancements to the sapacitabine
intellectual property estate extending existing patent protection, including
composition of matter, dosing regimen and combination treatment," said Spiro
Rombotis, President and Chief Executive Officer of Cyclacel. "We are executing
on our patent lifecycle strategy for the treatment of AML and MDS with the
goal of extending sapacitabine's exclusivity through 2030 and potentially
building long-term commercial value for our stockholders. We look forward to
providing additional updates for sapacitabine, including progress in SEAMLESS,
our pivotal Phase 3 trial in front-line elderly AML, the primary outcome in
our Phase 2 study of sapacitabine in MDS after front-line treatment failure,
and our other programs."
In particular, the USPTO issued US Patent No. US 8,530,445 ('445) which
includes claims to combinations of sapacitabine and DNA methyltransferase
inhibitors, pharmaceutical compositions comprising sapacitabine and DNA
methyltransferase inhibitors, and methods of using sapacitabine and DNA
methyltransferase inhibitors in the simultaneous, sequential or separate
treatment of proliferative disorders including cancer. Specifically claimed
DNA methyltransferase inhibitors include azacitidine and decitabine. The '445
patent provides exclusivity until 2029, excluding any patent term adjustments
which may extend its coverage. An equivalent European patent, EP 2307002, was
granted earlier in 2013 with the corresponding national European patents
expiring in 2029.
The USPTO also issued US Patent No. 8,536,188 ('188) which includes claims to
methods of treatment of AML or MDS using sapacitabine dosing regimens. The
sapacitabine regimen used in Cyclacel's SEAMLESS pivotal Phase 3 study of
sapacitabine alternating with decitabine versus decitabine as a frontline
treatment of elderly patients with AML who are unfit or have refused intensive
chemotherapy is specifically claimed.The '188 patent provides exclusivity
until 2028, excluding any patent term adjustments which may extend its
Sapacitabine (CYC682), an orally-available nucleoside analogue, is 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. Sapacitabine is in
Phase 2 trials in patients with hematological malignancies, including AML,
myelodysplastic syndromes (MDS), cutaneous T-cell lymphoma (CTCL), chronic
lymphocytic leukemia, small lymphocytic lymphoma, and also non-small cell lung
cancer (NSCLC), and a Phase 1 trial 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 (HR)
DNA repair pathway. Both sapacitabine and CNDAC, its major metabolite, have
demonstrated potent anti-tumor activity in preclinical studies.
Over 800 patients have received sapacitabine in clinical studies in patients
with AML, MDS, CTCL, NSCLC, hematological malignancies and solid tumors. At
the 2012 American Society of Hematology (ASH) Annual Meeting, data from the
pilot study and lead-in phase of SEAMLESS showed 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.
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.
Data, presented 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 and/or decitabine, showed
sapacitabine nearly doubled expected median survival of elderly patients with
MDS after front-line therapy failure.
At the 2013 American Association of Cancer Research (AACR) Annual Meeting
data, from a Phase 1 study of sapacitabine in combination with Cyclacel's
seliciclib, which showed antitumor activity in cancer patients found to be
carriers of gBRCA mutations was highlighted by the Annual Meeting Program
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. 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 gBRCA 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 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.
CONTACT: Cyclacel Pharmaceuticals, Inc.
Investors/Media: Paul McBarron,
(908) 517-7330, firstname.lastname@example.org
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