Cyclacel Announces Fadraciclib Abstract Selected for Oral Presentation in the Late Breaking and Best Proffered Paper Session ...
September 21 2020 - 7:00AM
Cyclacel Pharmaceuticals, Inc. (Nasdaq: CYCC) (Nasdaq: CYCCP)
(Cyclacel or the Company), a biopharmaceutical company developing
innovative medicines based on cancer cell biology, announced that
an abstract highlighting clinical data with Cyclacel's CDK2/9
inhibitor fadraciclib has been selected for an oral presentation at
the 32nd EORTC-NCI-AACR (ENA) Symposium 2020 being held
virtually on October 24 – 25, 2020. The data is from
an ongoing Phase 1 study of fadraciclib as a single agent in
patients with advanced solid tumors.
Details for the presentations are as follows:
Title: Phase 1 safety, pharmacokinetic and
pharmacodynamic study of fadraciclib (CYC065), a cyclin dependent
kinase inhibitor, in patients with advanced cancers
(NCT02552953)Session Title: Late Breaking and
Best Proffered Papers Session Date and Time:
Saturday 24 October 15:05
CETPresentation
Number: ORAL-002
The program can be accessed through the
EORTC-NCI-AACR website.
About Cyclin-Dependent Kinases and
Fadraciclib
Cyclin-dependent kinases (CDKs) are critical for cell cycle
regulation and transcriptional elongation. Dysregulated CDKs have
been linked to the cancer hallmarks of uncontrolled proliferation
and increased survival. Fadraciclib (CYC065) is a potent orally and
intravenously available inhibitor of CDK2 and CDK9.
In part 1 of a Phase 1, first-in-human study of fadraciclib as a
single agent in patients with advanced solid tumors, target
engagement and durable suppression of the MCL1 biomarker were
observed after a single dose of fadraciclib. Tumor shrinkage and
stable disease were observed in five patients with cyclin E, MCL1
and/or MYC amplified cancers.
The ongoing part 2 of the study is evaluating a more intensive
dosing regimen than part 1. A heavily pretreated patient with MCL1
amplified endometrial cancer achieved a radiographically confirmed
partial response (PR) after a month and a half on fadraciclib.
Fadraciclib is also being evaluated in Phase 1 combination studies
with venetoclax in patients with relapsed or refractory CLL and
AML/MDS.
Preclinical data suggest that fadraciclib may benefit patients
with adult and pediatric hematological malignancies such as AML,
ALL, B-cell lymphomas, CLL, multiple myeloma and certain cyclin
E-addicted or MYC-amplified solid tumors, including certain forms
of breast cancer, neuroblastoma, ovarian cancer and uterine serous
carcinoma.
About Cyclacel Pharmaceuticals, Inc.
Cyclacel Pharmaceuticals is a clinical-stage biopharmaceutical
company developing innovative cancer medicines based on cell cycle,
transcriptional regulation, and DNA damage response biology. The
transcriptional regulation program is evaluating fadraciclib as a
single agent in solid tumors and in combination with venetoclax in
patients with relapsed or refractory AML/MDS and CLL. The DNA
damage response program is evaluating an oral combination of
sapacitabine and venetoclax in patients with relapsed or refractory
AML/MDS. An investigator-sponsored trial (IST) is evaluating an
oral combination of sapacitabine and olaparib in patients with BRCA
mutant breast cancer. The anti-mitotic program is evaluating
CYC140, a PLK1 inhibitor, in advanced leukemias/MDS patients.
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, Eric Ando, (646) 218-4604,
eric.ando@russopartnersllc.com |
© Copyright 2020 Cyclacel Pharmaceuticals, Inc. All Rights
Reserved. The Cyclacel logo and Cyclacel® are trademarks of
Cyclacel Pharmaceuticals, Inc.
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