Cyclacel Announces Notice of Grant of New European Patent Covering Sapacitabine Pharmaceutical Formulations
21 February 2018 - 11:00PM
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 receipt of a notice from the
European Patent Office of the intention to grant a patent
(EP1962814) including claims to novel pharmaceutical formulations
of sapacitabine. The European patent will provide exclusivity until
December 2026 excluding any extensions. Equivalent patents have
been granted in the United States (US 8,497,291 expiring in January
2030) and other countries.
"This European notice of grant enhances the
intellectual property estate related to sapacitabine. The relevant
patent family is an important layer of our strategy of building on
sapacitabine's exclusivity. It supplements existing
composition of matter, dosing regimen and combination treatment
patent protection in major global markets extending into 2030,"
said Spiro Rombotis, President and Chief Executive Officer of
Cyclacel. "We look forward to providing updates on our progress
with sapacitabine, in terms of regulatory discussions regarding the
data from our SEAMLESS study in acute myeloid leukemia and updates
from our ongoing Phase 1 extension study evaluating the sequential
regimen of sapacitabine and seliciclib in patients with BRCA
positive, breast, ovarian and pancreatic cancers."
About sapacitabine
Sapacitabine (CYC682), an orally-available
nucleoside analogue, is currently being studied in an ongoing,
Phase 1 study evaluating a sequential regimen of sapacitabine and
seliciclib, a first generation CDK inhibitor. Parts 1 and 2 of the
study evaluated an enriched population of approximately 76 patients
with advanced cancers and were reported at ASCO 2016. The
ongoing extension of part 1 enrolled 20 patients with BRCA positive
advanced breast cancers and is in the follow-up stage. Part 3 of
the study has been opened for enrolment with the objective of
testing a revised dosing schedule in additional patients, including
BRCA positive patients with advanced ovarian and pancreatic
cancers.
Sapacitabine is also the subject of the Phase 3
SEAMLESS study of elderly patients with acute myeloid leukemia, or
AML. Data from this completed study were reported on December 11,
2017 in an oral presentation at the 59th ASH Annual
Meeting. Sapacitabine has been evaluated in both
hematological cancers and solid tumors. Over 1,000 patients have
received sapacitabine in Phase 1, 2 and 3 studies.
About Cyclacel Pharmaceuticals,
Inc.
Cyclacel Pharmaceuticals is a clinical-stage
biopharmaceutical company using cell cycle, transcriptional
regulation and DNA damage response biology to develop innovative,
targeted medicines for cancer and other proliferative diseases.
Cyclacel's transcriptional regulation program is evaluating CYC065,
a CDK inhibitor, in patients with advanced cancers. The DNA damage
response program is evaluating a sequential regimen of sapacitabine
and seliciclib, a CDK inhibitor, in BRCA positive patients with
advanced solid cancers. Cyclacel's strategy is to build a
diversified biopharmaceutical business focused in hematology and
oncology based on a pipeline of novel drug candidates. For
additional information, please visit www.cyclacel.com.
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.
Contacts
Company:
Paul
McBarron, (908) 517-7330, pmcbarron@cyclacel.com
Investor
Relations:
Russo Partners LLC, Alexander Fudukidis, (646) 942-5632,
alex.fudukidis@russopartnersllc.com
© Copyright 2018 Cyclacel Pharmaceuticals, Inc. All
Rights Reserved. The Cyclacel logo and Cyclacel® are trademarks of
Cyclacel Pharmaceuticals, Inc.
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