Cyclacel Pharmaceuticals Reviews 2018 Achievements and Announces Key Business Objectives for 2019
January 07 2019 - 7:00AM
Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP;
"Cyclacel" or the "Company"), a biopharmaceutical company
developing innovative medicines based on cancer cell biology, today
provided a business update reviewing 2018 achievements and
providing an outline of the Company’s key business objectives for
2019. Cyclacel’s clinical and business strategy will be highlighted
at a presentation during the 2019 Biotech Showcase Conference on
Tuesday, January 8, 2019 from 9:30 a.m. – 10:00 a.m. PST in the
Yosemite C Suite at the Hilton San Francisco Union Square.
"In 2018, we presented our targeted oncology
strategy with the objective of delivering important data readouts
in the next twelve months,” said Spiro Rombotis, President and
Chief Executive Officer. “At the heart of our business strategy is
targeting cancer patients with overexpression of resistance
pathways, including Mcl-1, and inherited mutations in DNA damage
pathways, including BRCA. Mcl-1, in particular, received wide
attention during 2018 medical conferences. We believe CYC065 is the
first investigational drug to have consistently demonstrated
durable suppression of Mcl-1 in clinical trials at tolerable
dosing. Our collaboration with MD Anderson Cancer Center to
evaluate three Cyclacel compounds in up to 170 patients is an
important development allowing us to advance our programs in a
P&L sparing manner. With estimated capital on hand until
mid-2020 we look forward to reporting data from our ongoing
clinical studies and realizing shareholder value from our targeted
drug pipeline.”
2018 Achievements
Transcriptional Regulation Program: CYC065 CDK
inhibitor
- Initiated a Phase 1 clinical trial evaluating CYC065, a CDK2/9
inhibitor, in combination with venetoclax in patients with
relapsed/refractory CLL. The strong biological rationale of dual
Mcl-1 and Bcl-2 suppression was presented at the 2018 AACR in a
poster titled “Strategic combination of the cyclin-dependent kinase
inhibitor CYC065 with venetoclax to target anti-apoptotic proteins
in chronic lymphocytic leukemia.” The data showed an enhanced
effect of the combination of CYC065 and venetoclax in CLL tumor
samples, including demonstrating activity in 17p deleted samples
which were resistant to either agent alone.
- Reported data from the Phase 1 part 1 clinical study of CYC065
monotherapy in advanced solid tumors at an oral presentation at the
2018 AACR. Prolonged reduction of Mcl-1 expression was
observed in 11 out of 13 patients treated at the recommended Phase
2 dose following a single dose of CYC065. Cyclacel continues to
enroll patients in part 2 of the study evaluating an increased
dosing frequency of CYC065 monotherapy for 2 days per week over 2
weeks of a three-week cycle, versus the once every 21 days schedule
evaluated in part 1. Part 2 will also look to evaluate the activity
of CYC065 in Mcl-1, MYC or cyclin E amplified cancers relevant to
CYC065’s mechanism of action.
DNA Damage Response (DDR) Program
- Dosed the first patient in the Phase 1b/2
investigator-sponsored combination study of sapacitabine in
combination with olaparib, an approved PARP inhibitor, in BRCA
positive patients with breast cancer. 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 such patients.
- Continued patient enrollment in part 3 of the Phase 1 study
evaluating a revised dosing schedule of sequential sapacitabine and
seliciclib, Cyclacel’s first-generation CDK inhibitor, in BRCA
positive patients with advanced breast, ovarian and pancreatic
cancer.
SEAMLESS Phase 3 Clinical Trial
- Received consistent guidance from three European regulatory
authorities with whom the company met to discuss a potential
approval pathway for sapacitabine. The discussions followed
submission of statistical and exploratory analyses demonstrating
sapacitabine’s potential clinical benefit in a subgroup of patients
with AML in the SEAMLESS Phase 3 study. The Company believes that
the subgroup results have defined a patient population for whom the
sapacitabine regimen may represent an improvement over low
intensity treatment by decitabine alone.
CYC140 PLK1 Inhibitor
- Completed IND review and initiated patient enrollment for a
Phase I first-in-human study evaluating CYC140 in patients with
advanced leukemias. CYC140 is an orally-available, small molecule,
selective polo-like-kinase 1 (PLK1) inhibitor that has demonstrated
potent and selective target inhibition and high activity in
xenograft models of human cancers.
Corporate Developments
- Entered into a collaboration with The University of Texas MD
Anderson Cancer Center to evaluate three Cyclacel medicines in
patients with hematological malignancies. MD Anderson will evaluate
CYC065, CYC140 and sapacitabine either as single agents or in
combination with approved drugs, in up to 170 enrolled patients
across four clinical trials.
- Added Robert J. Spiegel, M.D. to the Company’s Board of
Directors. Dr. Spiegel brings over 30 years of R&D and
operational experience in the biopharmaceutical industry as well as
advisory experience to venture capital and private equity
funds.
Key Business Objectives for 2019
- Report initial data readout from the CYC065 plus venetoclax
combination Phase 1 study in leukemias
- Report initial data readout from the CYC140 Phase 1
First-in-Human study
- Report initial data readout from the IST-sponsored Phase 1b/2
trial of sapacitabine and olaparib combination in BRCA positive
patients with breast cancer
- Complete enrollment in part 3 of the Phase 1 study of
sequential sapacitabine and seliciclib in BRCA positive, breast,
ovarian and pancreatic cancer patients
- Determine regulatory pathway and submissibility of sapacitabine
in elderly AML
- Evaluate bioequivalence of oral CYC065 formulation to
intravenously administered CYC065
About Cyclacel Pharmaceuticals, Inc.
Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical
company using its expertise in cell cycle, transcriptional
regulation and DNA damage response biology in cancer cells to
develop innovative medicines. The transcriptional regulation
program is evaluating CYC065, a CDK inhibitor, in patients with
advanced solid cancers and in combination with venetoclax in
patients with advanced hematological malignancies. The DNA damage
response program is evaluating a combination of sapacitabine and
seliciclib, a CDK inhibitor, in BRCA positive patients with
advanced solid cancers and sapacitabine and olaparib, a PARP
inhibitor, in BRCA positive patients with breast cancer. CYC140, a
PLK inhibitor, is in a Phase 1 first-in-human study in patients
with advanced leukemias. 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 StatementsThis
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 2019 Cyclacel Pharmaceuticals, Inc. All Rights
Reserved. The Cyclacel logo and Cyclacel® are trademarks of
Cyclacel Pharmaceuticals, Inc.
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