Cyclacel Reviews 2017 Achievements and Announces Key Business Objectives for 2018
January 09 2018 - 7:00AM
Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP)
(Cyclacel or the Company) reviewed its 2017 achievements and
provided an outline of the Company's key business objectives for
2018. These will be highlighted at the Company's presentation
during the Biotech Showcase™ 2018 Conference at 2:30 p.m. PST,
Tuesday, January 9, 2018, at the Hilton San Francisco Union Square
in San Francisco.
“During 2017, we selected a recommended Phase 2 dose (RP2D), for
our CYC065 CDK inhibitor, and advanced our clinical programs in
selected patient populations relevant to the drugs’ mechanism,”
said Spiro Rombotis, President and Chief Executive Officer of
Cyclacel. “In an ongoing, Phase 1 study, CYC065 demonstrated
durable target engagement and biomarker suppression at well
tolerated doses in 11 out of 13 patients treated at the RP2D.
Initial anticancer activity was observed in five patients.
In 2018, we plan to initiate a translational clinical study
to evaluate CYC065 in combination with venetoclax in chronic
lymphocytic leukemia, or CLL; design clinical studies for CYC065
alone and with standard of care in solid tumors, including certain
pediatric cancers. Data from the Phase 3 SEAMLESS study of
sapacitabine were recently presented at the American Society of
Hematology, or ASH, Annual Meeting. The presentation included
additional data emerging from a comprehensive analysis of
prespecified subgroups, e.g. low peripheral white blood cell count,
which will form the basis of the Company’s consultations with
regulatory authorities. Following our July offering, we project
cash resources to fund currently planned programs through the end
of 2019. We look forward to reporting our progress in
2018.”
2017 Achievements
Drug Development
Transcriptional Regulation Program:
CYC065 CDK inhibitor
- In part 1 of the ongoing, first-in-human, single agent,
ascending dose, Phase 1 study, prolonged reduction of Mcl-1 was
observed in 11 out of 13 evaluable patients treated at the RP2D
following a single dose of CYC065, which was generally well
tolerated. Preliminary anticancer activity was observed in 5
patients, of which 4 were treated at the RP2D and 3 of which were
reported by investigators to have molecular features of their
cancers associated with CYC065’s mechanism of action, including
overexpression or amplification of Mcl-1, MYC and/or cyclin E.
The trial is being conducted at the Dana Farber Cancer
Institute in Boston. Part 2 of the Phase 1 translational
study will evaluate additional dosing schedules in patients with
advanced solid tumors, in particular those with amplification of
cyclin E, Mcl-1 or MYC, including subsets of high grade serous
ovarian and uterine cancers. Biospecimens will be collected
for assessment of biomarkers related to CYC065’s mechanism of
action.
- Discussions with principal investigators and/or cooperative
groups progressed with the objective of evaluating CYC065 in both
pediatric and adult patients. One such study, to be conducted
as an investigator sponsored trial, will evaluate the drug in
patients with leukemias, including AML, and in particular those
with mixed lineage leukemia rearrangements, or MLL-r. In
parallel, the Company is discussing with investigators the
potential evaluation of CYC065 in patients with neuroblastoma, a
mostly pediatric life-threatening malignancy, frequently associated
with MYC amplification.
- Preclinical data presented and published on the molecular
rationale and therapeutic potential of CYC065, a CDK2/9 inhibitor:
- In an article published in the Journal of National Cancer
Institute (JNCI), preclinical data demonstrated that both CYC065
and CCT68127, Cyclacel’s preclinical stage CDK2/9 inhibitor,
demonstrated prominent antitumor activity against lung cancer
through anaphase catastrophe, a novel, cancer specific mechanism of
action. CYC065 was found to be effective against lung cancer
cell lines including those with KRAS mutations.
- At the American Association for Cancer Research (AACR) Annual
Meeting 2017, independent investigators presented preclinical data
demonstrating therapeutic potential of CYC065 as a targeted
anti-cancer agent. The data show that CYC065 substantially
inhibited growth, triggered apoptosis, and induced anaphase
catastrophe in murine and human lung cancer cells with known high
metastatic potential. This was in marked contrast to effects
in immortalized pulmonary epithelial murine and human cells.
CYC065 markedly inhibited migration and invasion of lung
cancer cells and affected distinctive pathways involved in DNA
damage response, apoptosis, cell cycle regulation and cell
migration.
DNA Damage Response
(DDR) Program
- Enrollment has been completed in an extension of the Phase 1
study evaluating the combination regimen of sapacitabine and
seliciclib, our first generation CDK inhibitor, in an enriched
population of approximately 20 patients with BRCA positive advanced
breast cancer.
- Part 3 of this study has been opened for enrolment with the
objective of testing a revised dosing schedule in additional
patients, including BRCA positive, ovarian and pancreatic cancer
patients.
SEAMLESS Phase 3 Study
- Data from the SEAMLESS study of sapacitabine in acute myeloid
leukemia, or AML, were the subject of an oral presentation at the
59th ASH Annual Meeting in Atlanta, Georgia, on December 11,
2017.
- The presentation included additional data from a comprehensive
analysis of the SEAMLESS dataset with the objective of
characterizing the prespecified subgroups of patients, e.g. those
with low peripheral white blood cell count, who appeared to have
clinically relevant benefit from the investigational treatment
regimen.
- As previously reported, in the intent-to-treat population, the
investigational arm of the SEAMLESS study did not reach
statistically significant improvement in OS versus an active
control. However, improvement in OS was observed in a
stratified subgroup of patients with low baseline peripheral white
blood cell count. The subgroup comprised approximately
two-thirds of the study's population.
- Following analysis of the full SEAMLESS data set and database
lock, the Company is developing submission materials to support
consultations with European and US authorities with the objective
of determining potential regulatory pathways.
PLK1 Inhibitor; CYC140
- Presented at the American Academy of Cancer Research (AACR)
Annual Meeting 2017, preclinical data outlining the potential
therapeutic utility of CYC140, a novel polo-like kinase (PLK) 1
inhibitor, alone and in synergistic drug combinations, for the
treatment of esophageal cancer and acute leukemia.
Corporate Developments
- Raised net proceeds of approximately $13.7 million from an
underwritten public offering.
2018 Key Upcoming Business Objectives
- Initiate CYC065 Phase 1b in relapsed/refractory CLL in
combination with venetoclax, a Bcl-2 inhibitor
- Update CYC065 Phase 1 data in solid tumors
- Update mature data from the part 1 extension
sapacitabine/seliciclib DDR study in the BRCA +ve breast cancer
cohort
- Complete part 3 in the sapacitabine/seliciclib DDR study in
patients with BRCA +ve cancers, including ovarian and
pancreatic
- Submit CYC140 (PLK1 inhibitor) IND application
- Conduct regulatory authority meetings regarding the SEAMLESS
study of sapacitabine in AML
For the live and archived webcast of the Company's presentation
at the Biotech Showcase™ 2018 San Francisco conference, please
visit the Corporate Presentations page on the Cyclacel website at
www.cyclacel.com. The webcast will be archived for 90 days and the
audio replay for seven days.
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 |
© Copyright 2018 Cyclacel Pharmaceuticals, Inc. All
Rights Reserved. The Cyclacel logo and Cyclacel® are registered
trademarks.
Cyclacel Pharmaceuticals (NASDAQ:CYCC)
Historical Stock Chart
From Aug 2024 to Sep 2024
Cyclacel Pharmaceuticals (NASDAQ:CYCC)
Historical Stock Chart
From Sep 2023 to Sep 2024