Researchers to Present New Phase 2 Data on Sapacitabine as a Treatment for
Patients With MDS at ASH Annual Meeting
- Including Primary Endpoint of One Year Survival to Select a Dosing Schedule
for Phase 3 Study -
BERKELEY HEIGHTS, N.J., Nov. 7, 2013 (GLOBE NEWSWIRE) -- Cyclacel
Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) (Cyclacel or the Company),
today announced that researchers will present new data from an ongoing,
multicenter, Phase 2 randomized trial of oral sapacitabine capsules, the
Company's lead product candidate, in older patients with intermediate-2 or
high-risk myelodysplastic syndromes (MDS) after treatment failure of
front-line hypomethylating agents, such as azacitidine and/or decitabine, at
the 55th Annual Meeting of the American Society of Hematology (ASH). The data
include the primary endpoint of one year survival which will enableselection
of a dosing schedule for aPhase 3study.
An abstract summarizing the data is published on the ASH website
(https://ash.confex.com/ash/2013/webprogram/Paper63484.html). The ASH annual
meeting will be held December 7-10, 2013 in New Orleans, LA. Further
information related to the data is embargoed until the time of presentation in
accordance with the meeting's embargo policy.
The sapacitabine abstract information is as follows:
Session Name: 633. Myelodysplastic Syndromes: Poster II
Abstract 2752: "A Randomized Phase II Study Of Sapacitabine In MDS Refractory
To Hypomethylating Agents" Garcia-Manero, et al.
Date: Sunday, December 8, 2013
Presentation Time: 6:30 PM - 8:30 PM
Location: Ernest N. Morial Convention Center, Hall E
About Myelodysplastic Syndromes (MDS)
MDS is a family of clonal myeloid neoplasms, or malignancies of the blood,
caused by the failure of blood cells in the bone marrow to develop into mature
cells. Patients with MDS typically suffer from bone marrow failure and
cytopenias, or reduced counts of platelets, red and white blood cells. The
exact incidence and prevalence of MDS are unknown because it can go
undiagnosed and a national survey canvassing both hospitals and office
practitioners has not been completed. Some estimates place MDS incidence at
15,000 to 20,000 new cases each year in the US alone with some authors
estimating incidence as high as 30,000 to 46,000. Literature evidence suggests
that there is a rising incidence of MDS as the age of the population increases
with the majority of patients aged above 60 years.
Median survival for patients with intermediate-2 or high-risk disease, as
defined by the International Prognostic Scoring System (IPSS), is 4.3 to 5.6
months. Patients with high IPSS scores also have a high probability of
experiencing transformation of their MDS into AML, an aggressive form of blood
cancer with typically poor survival.
Sapacitabine (CYC682), an orally-available nucleoside analogue, is being
studied in SEAMLESS, an ongoing, Phase 3, registration-directed trial in
elderly patients aged 70 years or older with newly diagnosed AML who are not
candidates for or have refused induction chemotherapy. Sapacitabine is in
Phase 2 trials in patients with hematological malignancies, including AML,
myelodysplastic syndromes (MDS), cutaneous T-cell lymphoma (CTCL), chronic
lymphocytic leukemia, small lymphocytic lymphoma, and also non-small cell lung
cancer (NSCLC), and a Phase 1 trial with seliciclib in patients with advanced
solid tumors. Sapacitabine acts through a novel DNA single-strand breaking
mechanism, leading to production of DNA double strand breaks (DSBs) and/or
checkpoint activation. Unrepaired DSBs cause cell death. Repair of
sapacitabine-induced DSBs is dependent on the homologous recombination (HR)
DNA repair pathway. Both sapacitabine and CNDAC, its major metabolite, have
demonstrated potent anti-tumor activity in preclinical studies.
Over 800 patients have received sapacitabine in clinical studies in patients
with AML, MDS, CTCL, NSCLC, hematological malignancies and solid tumors. At
the 2012 American Society of Hematology (ASH) Annual Meeting, data from the
pilot study and lead-in phase of SEAMLESS showed promising response rate,
overall survival and low 30-day and 60-day mortality in elderly patients with
AML aged 70 years or older receiving sapacitabine alternating with decitabine.
Results from a randomized Phase 2, single-agent study of sapacitabine,
including promising 1-year survival in elderly patients with AML aged 70 years
or older, were published in The Lancet Oncology in November 2012.
Data, presented at The Eighth Annual Hematologic Malignancies 2012 Conference,
from an ongoing, multicenter, Phase 2 randomized trial of single-agent oral
sapacitabine capsules in older patients with intermediate-2 or high-risk
myelodysplastic syndromes (MDS) after treatment failure of front-line
hypomethylating agents, such as azacitidine and/or decitabine, showed
sapacitabine nearly doubled expected median survival of elderly patients with
MDS after front-line therapy failure.
At the 2013 American Association of Cancer Research (AACR) Annual Meeting
data, from a Phase 1 study of sapacitabine in combination with Cyclacel's
seliciclib, which showed antitumor activity in cancer patients found to be
carriers of gBRCA mutations was highlighted by the Annual Meeting Program
The FDA and the European Medicines Agency have designated sapacitabine as an
orphan drug for the treatment of both AML and MDS. Sapacitabine is part of
Cyclacel's pipeline of small molecule drugs designed to target and stop
uncontrolled cell division.
About Cyclacel Pharmaceuticals, Inc.
Cyclacel is a biopharmaceutical company developing oral therapies that target
the various phases of cell cycle control for the treatment of cancer and other
serious diseases. Sapacitabine, Cyclacel's most advanced product candidate, is
the subject of SEAMLESS, a Phase 3 trial being conducted under an SPA with the
FDA as front-line treatment for acute myeloid leukemia (AML) in the elderly,
and other studies for myelodysplastic syndromes (MDS), chronic lymphocytic
leukemia (CLL) and solid tumors including breast, lung, ovarian and pancreatic
cancer, and in particular those carrying gBRCA mutations. Cyclacel's strategy
is to build a diversified biopharmaceutical business focused in hematology and
oncology based on a development pipeline of novel drug candidates. Please
visit www.cyclacel.com for additional information.
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.
© Copyright 2013 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The
Cyclacel logo and Cyclacel® are trademarks of Cyclacel Pharmaceuticals, Inc.
CONTACT: Cyclacel Pharmaceuticals, Inc.
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