Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP)
"Cyclacel" or the "Company"), a biopharmaceutical company
developing oral therapies that target various phases of cell cycle
control for the treatment of cancer and other serious disorders,
today announced results from the Company's Phase 3 SEAMLESS study.
Cyclacel had previously announced top-line results from its Phase 3
SEAMLESS study in February 2017. The study enrolled elderly
patients with newly diagnosed acute myeloid leukemia (AML) and
compared alternating cycles of decitabine and sapacitabine versus
decitabine. Data were reported at an oral presentation on Monday,
December 11, at 6:45 PM EST at the 59th American Society of
Hematology Annual Meeting in Atlanta, Georgia.
“Although the study did not reach its primary endpoint of
superiority in survival, we are encouraged by the higher complete
remission rate on the sapacitabine-decitabine arm, especially in
the subgroup with low white blood cell count; additional analysis
of the data should be pursued,” said Hagop Kantarjian, M.D.,
Professor and Chair, Department of Leukemia, The University of
Texas MD Anderson Cancer Center, and chair of the study.
"We are pleased to report detailed results of the SEAMLESS
study, which as previously announced, did not reach its primary
endpoint,” said Spiro Rombotis, President and Chief Executive
Officer of Cyclacel. “We believe that the subgroup results have
defined a patient population for whom the decitabine-sapacitabine
regimen may represent an improvement over low intensity treatment
by decitabine alone. We plan to discuss the data, the statistical
robustness of the subgroup results and the optimal baseline
peripheral white blood cell (WBC) cutpoint with European and US
regulatory authorities and will provide updates as appropriate. We
are grateful to the patients, their families and the investigators
for their contributions to this large study. In parallel, we
are progressing our other clinical programs in transcriptional
regulation with CYC065 and DNA damage response with
sapacitabine-seliciclib in biomarker-selected patients with solid
tumors, such as those with BRCA mutations or resistance to existing
cancer therapies.”
Study Design & Intent-to-Treat Results
The randomized, open label, Phase 3 SEAMLESS study enrolled 482
patients, aged 70 years or older, with newly diagnosed AML who were
not candidates for or refused intensive therapy at 110 US and EU
sites. Patients were stratified by WBC, antecedent hematologic
disorder (AHD), and marrow blasts, and randomized 1:1 to receive
either intravenous decitabine administered in alternating cycles
with oral sapacitabine versus intravenous decitabine alone.
The trial did not meet its primary endpoint of demonstrating
statistically significant improvement in overall survival. A
higher complete remission (CR) rate, a secondary endpoint, was
observed on the decitabine-sapacitabine arm (17% versus 11%).
Other endpoints and safety were similar between the arms.
Prespecified Subgroup Analysis
Baseline WBC
In the less than 10,000 WBC subgroup (n=319) a trend towards
improved overall survival (median 8.0 versus 5.8 months, HR=0.84
[0.66, 1.06], p=0.14) favoring decitabine-sapacitabine and a
significantly higher CR rate (21.0% versus 8.6%, p=0.0017) was
achieved on decitabine-sapacitabine.
In the 10,000 or more WBC subgroup (n=163) significantly better
overall survival (median 3.8 versus 5.5 months, HR=1.57 [1.12,
2.19], p=0.007) was observed on decitabine. A trend in CR rate
(8.3% versus 15.2%, p=0.18) favoring decitabine was observed but it
did not reach statistical significance.
Prior AHD
In the subgroup with prior AHD (n=136) a significantly higher CR
rate (16.7% versus 5.7%, p=0.0398) was achieved on
decitabine-sapacitabine. There was a numerical difference in median
survival (6.4 versus 5.0 months, HR=0.85 [0.59, 1.24], p=0.41)
favoring decitabine-sapacitabine but overall survival did not reach
statistical significance.
In the subgroup without prior AHD (n=346) there was a numerical
difference in median survival (5.9 versus 6.7 months, HR=1.08
[0.86, 1.35], p=0.52) favoring decitabine and CR rate (16.6% versus
12.9%) favoring decitabine-sapacitabine but neither reached
statistical significance.
Cytogenetics
In the subgroup with other than unfavorable cytogenetics (n=288)
there was a numerical difference in median survival (8.2 versus 5.7
months, HR=0.89 [0.69, 1.15], p=0.38) and CR rate (19.9% versus
11.6%, p=0.16) favoring decitabine-sapacitabine but neither reached
statistical significance.
In the subgroup with unfavorable cytogenetics (n=194) there was
a numerical difference in median survival (3.8 months versus 5.7
months, HR=1.27 [0.94, 1.73], p=0.12) favoring decitabine but
overall survival did not reach statistical significance.
There was a numerical difference in CR rate favoring
decitabine-sapacitabine (12.0% versus 9.6%) but it did not reach
statistical significance.
In the subgroup of patients with below 50% and with 50% or
higher bone marrow blasts there were no statistically significant
differences in overall survival between the arms.
Presentation
The presentation (abstract 891), titled "Results of a Phase 3
Study of Elderly Patients with Newly Diagnosed AML Treated with
Sapacitabine and Decitabine Administered in Alternating Cycles," is
available on the Cyclacel website at www.cyclacel.com.
About Sapacitabine
Sapacitabine (CYC682), an orally-available nucleoside analogue,
is currently being studied in an ongoing, extension of a Phase 1
study evaluating a combination regimen of sapacitabine and
seliciclib, a first generation CDK inhibitor. Parts 1 and 2 of the
study evaluated approximately 90 patients with advanced cancers.
Part 3 is ongoing in patients with BRCA positive, breast, ovarian
and pancreatic cancer. Over 1,000 patients with hematological
malignancies and solid tumors have received sapacitabine.
About AML
AML is a rapidly progressing cancer of the blood characterized
by the uncontrolled proliferation of immature blast cells in the
bone marrow. The American Cancer Society estimates there will be
approximately 21,380 new cases of AML and approximately 10,590
deaths from AML in the U.S. in 2017. AML is generally a disease of
older adults and the median age is about 67 years. Newly diagnosed
elderly patients with poor prognostic risk factors typically die
within one year.
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 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.
Contacts |
|
Company: |
Paul McBarron, (908)
517-7330, pmcbarron@cyclacel.com |
Investor
Relations: |
Russo Partners LLC,
Alexander Fudukidis, (646) 942-5632,
alex.fudukidis@russopartnersllc.com |
|
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