Cyclacel Pharmaceuticals Announces Initiation of Phase 1b/2 Clinical Trial of Sapacitabine With Olaparib in BRCA Mutant Breas...
September 10 2018 - 7:00AM
Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC, Nasdaq:CYCCP)
("Cyclacel" or the "Company"), a biopharmaceutical company
developing innovative medicines based on cancer biology, announced
the initiation of a Phase 1b/2 investigator-sponsored clinical
trial to evaluate the safety and effectiveness of sapacitabine in
combination with olaparib in patients with BRCA mutant breast
cancer. The trial will be conducted at the Dana-Farber Cancer
Institute with collaborators Cyclacel and AstraZeneca providing
sapacitabine investigational drug and the approved PARP-inhibitor
olaparib (LynparzaTM), respectively.
“Despite advancements in the treatment of BRCA positive breast
cancer, we are continually searching for ways to improve on the
standard of care for this disease which carries a poor prognosis
for the majority of individuals,” said Sara M. Tolaney, MD, MPH,
instructor of medicine, Harvard Medical School, attending physician
of medical oncology, Dana-Farber Cancer Institute and Principal
Investigator of the study. “PARP inhibitor monotherapy is the
current standard of care for breast and ovarian cancers with
homologous recombination deficient (HRD) cancers, which include
those positive for BRCA mutations. The study will help determine if
the all-oral combination of sapacitabine and olaparib could provide
additional benefit to these patients for whom limited treatment
options exist.”
“Preclinical data support additivity or synergy of sapacitabine
with PARP inhibitors. We believe that dual targeting of the DNA
damage response pathway with the addition of sapacitabine to
olaparib may enhance the efficacy of the current standard of care
for patients with BRCA positive breast cancer,” said Spiro
Rombotis, President and Chief Executive Officer of Cyclacel. “We
are excited about this collaboration and the potential to improve
outcomes for a difficult to treat patient population with a
convenient, orally administered drug combination.”
The investigator-sponsored Phase 1b/2 study will enroll
approximately 64 patients with breast cancer and BRCA1 or BRCA2
mutation. The primary endpoints are to determine maximum
tolerated dose, recommended Phase 2 dose and objective response
rate. Progression-free survival will be assessed as a secondary
endpoint. The first of two parts of the study will assess safety
and tolerability of escalating doses of the combination. The second
part will assess efficacy of the recommended Phase 2 dose in 18
patients. If a prespecified number of these patients achieve a
complete or partial response per RECIST 1.1 criteria, the study
will be expanded to a further 28 patients (www.clinicaltrials.gov,
NCT03641755).
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 medicines based on cancer
biology. 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
patients with BRCA positive, 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.
ContactsCompany:
Paul
McBarron, (908) 517-7330, pmcbarron@cyclacel.comInvestor
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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