Full Press Release Details
CYCLACEL BEGINS PIVOTAL PHASE 3
"SEAMLESS" TRIAL OF SAPACITABINE AS
FRONT-LINE TREATMENT FOR
AML UNDER A SPECIAL PROTOCOL ASSESSMENT
- Cyclacel to host conference
call at 4:30 pm ET on Tuesday, January 18, 2011 to discuss study design
Berkeley Heights, NJ,
January 11, 2011 - Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC,
NASDAQ: CYCCP; "Cyclacel" or the "Company"), today
announced that it has opened enrollment of the SEAMLESS pivotal Phase 3 trial
for the Company's sapacitabine oral capsules as a front-line treatment of
elderly patients aged 70 years or older with newly diagnosed acute myeloid
leukemia (AML) who are not candidates for intensive induction
chemotherapy. The study is being conducted under a Special Protocol Assessment
(SPA) agreement that Cyclacel reached with the U.S. Food and Drug
Administration (FDA). SEAMLESS builds on promising 1-year survival observed in
elderly patients aged 70 years or older with newly diagnosed AML or AML in
first relapse enrolled in a Phase 2 study of single agent sapacitabine.
"The opening of the SEAMLESS
study for patient enrollment marks an important milestone for Cyclacel as this
is the first pivotal Phase 3 trial ever conducted by the Company," said
Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "If it
reaches the market, sapacitabine will become an important treatment option for
many elderly patients who are suffering from this life-threatening disease. We
also look forward to interim data from the Phase 2 study of sapacitabine in
Non-Small Cell Lung Cancer (NSCLC). Sapacitabine may be one of few cancer drugs
with activity against both hematological malignancies and solid tumors."
The SEAMLESS study is chaired by
Hagop M. Kantarjian, M.D., Chairman and Professor, Department of Leukemia, The
University of Texas MD Anderson Cancer Center, Houston, Texas. SEAMLESS is a
multicenter, randomized, Phase 3 study comparing three treatment arms. In Arm A
sapacitabine is administered in alternating cycles with decitabine, in Arm B
sapacitabine is administered alone and in Arm C decitabine is administered
alone. The primary efficacy endpoint is overall survival. The study is designed
to demonstrate an improvement in overall survival of either of two pairwise
comparisons: (1) Arm A versus Arm C or (2) Arm B versus Arm C.
Approximately 150 patients per arm or a total of 450 patients from
approximately 50 centers will be enrolled. SEAMLESS will be monitored by a Data
Safety Monitoring Board (DSMB). A prespecified interim analysis for futility
will be performed and reviewed by the DSMB.
"We chose decitabine as an
active control arm as it is one of the treatment options recommended by the
National Comprehensive Cancer Network's Clinical Practice Guidelines. We
are pleased to learn that this active control arm is acceptable to AML
investigators." said Judy Chiao, M.D., Vice President of Clinical
Development and Regulatory Affairs of Cyclacel. "AML in the elderly is a
life-threatening disease with high unmet medical need. Patients with AML aged
70 years or older have a poor prognosis, as the majority of these patients
are not candidates for intensive induction chemotherapy because of poor
tolerability to such therapy and a high risk of relapse because of the lack of
effective consolidation and maintenance therapy. If the SEAMLESS study is
successful, sapacitabine may significantly improve the outcome of this
devastating disease in elderly patients."
The treatment regimen of
sapacitabine administered in alternating cycles with decitabine has been found
to be safe and efficacious in an on-going pilot study conducted at The
University of Texas MD Anderson Cancer Center. In addition, SEAMLESS
has a lead-in stage to further confirm the safety and efficacy of the
alternating treatment regimen in the multicenter setting.
200 Connell Drive, Suite 1500, Berkeley
Heights, NJ 07922 USA T: +1 (908) 517 7330 F: +1 (866) 271
Dundee Technopole, James Lindsay
Place, Dundee, DD1 5JJ, UK Tel +44 1382 206 062 Fax +44 1382 206 067
The FDA has designated sapacitabine
as an orphan drug for the treatment of both AML and myelodysplastic syndromes
Conference call and Webcast
Cyclacel management will review the
SEAMLESS trial design on a conference call scheduled for January 18, 2011
at 4:30 p.m. Eastern. Conference call and webcast details are as follows:
US/Canada call: (877) 493-9121/
international call: (973) 582-2750
(800) 642-1687 / international archive: (706) 645-9291
live and archived conference call is 36660893.
Webcast: For the live and archived
webcast, 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 7 days.
About Acute Myeloid Leukemia
AML is a cancer of the blood cells
that progresses rapidly and if not treated, could be fatal in a few months. AML
is generally a disease of older people and is uncommon before the age of 40.
The average age of a patient with AML is about 67 years. There are more
than 12,300 new cases of AML, of which about half are elderly, and nearly 9,000
deaths caused by this cancer each year in the United States. A recently
published review of The University of Texas MD Anderson Cancer Center's
historical experience with front-line intensive induction chemotherapy for
elderly AML patients aged 70 years or older demonstrated that while 45% of
patients achieved a complete remission, median overall survival was only
4.6 months and 36% of patients died within the first 8 weeks of
treatment, underscoring the unmet need in this patient setting (Kantarjian, H,
et al, Blood, DOI 10.1182/blood-2010-03-276485).
About Special Protocol Assessment
A Special Protocol Assessment is a
binding written agreement with the FDA that the sponsor's proposed trial
protocol design, clinical endpoints and statistical analyses are acceptable to
support regulatory approval. Final marketing approval depends on efficacy
results, adverse event profile and an evaluation of the benefit/risk of a
treatment as demonstrated in the trial. For further information regarding the
SPA process, please visit the FDA website, www.fda.gov.