Cyclacel Reviews 2013 Achievements and Announces Key Business Objectives for
- Company to Present at the Biotech Showcase(TM) 2014 Conference at 9:30 a.m.
PST, Monday, Jan. 13, 2014 -
BERKELEY HEIGHTS, N.J., Jan. 13, 2014 (GLOBE NEWSWIRE) -- Cyclacel
Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) (Cyclacel or the Company)
today reviewed 2013 achievements and provided an outline of the Company's key
clinical development objectives for 2014, which will be highlighted at the
Company's presentation during the Biotech Showcase™ 2014 Conference at 9:30
a.m. PST, Monday, Jan. 13, 2014, at the Parc 55 Wyndham Hotel – Union Square
at 55 Cyril Magnin Street in San Francisco.
"During 2013, we continued to progress with the clinical development of
sapacitabine in acute myeloid leukemia (AML) and myelodysplastic syndromes
(MDS)," said Spiro Rombotis, President and Chief Executive Officer of
Cyclacel. "In our SEAMLESS, Phase 3, registration-directed study of
sapacitabine in elderly patients with newly diagnosed AML, our lead
indication, we have achieved 50% enrollment and expect to at least double
enrolling sites by expanding into Europe. In addition, the independent Data
Safety Monitoring Board overseeing SEAMLESS recently recommended, after a
review of 212 randomized patients, that the study should continue as planned
and identified no safety or efficacy concerns. With regard to MDS, Phase 2
data reported at ASH 2013 showed a one year survival outcome at 38% with a
near doubling of expected median survival of older patients with MDS after
treatment failure of hypomethylating agents."
"For 2014, we are focused on completing the enrollment of SEAMLESS by the end
of the year. The Company is funded to achieve this milestone. Additionally, we
plan to advance the clinical development of sapacitabine in MDS and other
cancers using existing resources, including the funding agreement with Aspire
Capital, and advance our earlier pipeline, including CYC065, our
second-generation cyclin dependent kinase (CDK) inhibitor, which is supported
by government grant funding."
2013 Milestones and Accomplishments
*Sapacitabine in SEAMLESS, our pivotal Phase 3 study for first-line
treatment in elderly patients with AML:
*Study enrolment reached 50% in 2013; expansion into Europe expected to
at least double the number of enrolling sites.
*The independent Data Safety Monitoring Board (DSMB) performed the third
periodic safety review and recommended that the study should continue as
planned after reviewing available data from 212 randomized patients. The
DSMB noted that no safety or efficacy concerns were identified. SEAMLESS
is being conducted under a Special Protocol Assessment (SPA) agreement
with the U.S. Food and Drug Administration (FDA).
*Sapacitabine in MDS
*Reported primary endpoint data from an ongoing, open-label, multicenter,
randomized Phase 2 trial of sapacitabine in older patients with MDS
after treatment failure of front-line hypomethylating agents, such as
azacitidine and/or decitabine. The 7-day dose regimen (Arm G) appears to
be a better schedule with a one-year survival rate of 38%, median
overall survival of approximately 10 months and response rate of 19%.
The 30-day mortality from all causes for all patients is 5%. Data were
presented at a poster on Dec. 8, 2013 during the 2013 American Society
of Hematology (ASH) Meeting and Exposition held in New Orleans.
*Sapacitabine in solid tumors
*Announced updated data showing that sapacitabine has activity against a
majority of ovarian cancer samples taken from patients, including
resistant tumors. The data were reported at a poster presentation during
the American Association of Cancer Research (AACR) conference "Advances
in Ovarian Cancer from concept to clinic" held in Sep. 2013.
*Reported updated data from an open label, single arm, Phase 1 escalation
trial of sapacitabine and the company's seliciclib, a CDK inhibitor, as
an all-oral, sequentially-administered regimen in heavily-pretreated
patients with advanced solid tumors. Of 38 patients with incurable solid
tumors and adequate organ function enrolled in the study, 16 were found
to be BRCA mutation carriers. Four patients with BRCA-deficient, breast,
ovarian and pancreatic cancers achieved confirmed partial responses with
promising durability, with the longest lasting more than 78 weeks.
Stable disease of 12 weeks or more was observed in eight additional
patients, including two with BRCA-deficient ovarian and breast cancers,
lasting 64 weeks and 21 weeks respectively.The data was reported at the
at the 104th Annual Meeting of the AACR and the AACR Annual Meeting
Program Committee selected this study for inclusion at a press
conference highlighting major developments reported during the Annual
*Reported that the US Patent and Trademark Office (USPTO) issued multiple
patents extending the market exclusivity of sapacitabine to at least
2030. The patents claim, among others, methods of use for sapacitabine
for the treatment of AML and MDS, including the dosing regimen used in
SEAMLESS, as well as claims to methods of treating cancer comprising
sapacitabine together with DNA methyltransferase inhibitors, including
azacitidine and decitabine, and combination treatment of sapacitabine
with HDAC (histone deacetylase) inhibitors in various cancers.
*Announced that oral seliciclib (a CDK2, -7, -9 inhibitor) is to be
evaluated in an investigator-initiated clinical study to treat
rheumatoid arthritis (RA) supported by an approximately $1.5 million
grant from the U.K.'s Medical Research Council. Enabled by the clinical
development experience in solid tumors, investigators believe that
seliciclib's mechanism of action and oral administration route may be of
benefit in treating patients with RA.
*Progressed investigational new drug (IND)-directed preclinical
development of CYC065, a novel, orally available, second generation, CDK
inhibitor, supported by a grant award of approximately $1.9 million from
the UK Government's Biomedical Catalyst.
*Received a grant award of approximately $3.7 million from the UK
Government's Biomedical Catalyst to complete IND-directed preclinical
development of CYC140, a novel, orally available, Polo-Like Kinase 1
oReceived $5.5 million from Celgene Corporation (Celgene) for the sale of
four Cyclacel romidepsin-related patents to Celgene and dismissal of all
claims in the related patent litigation.
oClosed an underwritten offering for net proceeds of approximately $19.0
million after deduction of offering expenses.
oConverted 877,869 shares of preferred stock into 1,684,471 shares of
common stock and as a result, 335,273 shares of preferred stock remain
oEntered into a common stock purchase agreement with Aspire Capital Fund,
LLC (Aspire) where Aspire has committed to purchase up to $20 million of
Cyclacel's common stock from time to time as directed by Cyclacel over the
next two years at formula prices based on the market price at the time of
2014 Key Upcoming Business Objectives
*Sapacitabine in SEAMLESS:
*Continue enrollment and expand study into Europe to at least double
*Report next interim periodic DSMB review at approximately 300 patients
*Report DSMB interim analysis for futility after 212 events
*Sapacitabine in MDS:
*Announce registration-directed, clinical development plan in 2nd line
MDS following treatment failure after hypomethylating agents
*Sapacitabine in solid tumors:
*Report updated Phase 1 sapacitabine and seliciclib combination data in
patients with solid tumors including those carrying the gBRCA mutation
*Advance early pipeline
For the live and archived webcast of the Company's presentation at the Biotech
Showcase™ 2014 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 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 2014 Cyclacel Pharmaceuticals, Inc. All Rights Reserved. The
Cyclacel logo and Cyclacel^® are trademarks of Cyclacel Pharmaceuticals, Inc.
CONTACT: Cyclacel Pharmaceuticals, Inc.
Paul McBarron, (908) 517-7330, email@example.com
Cyclacel Pharmaceuticals logo
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