Sep 12 2008, 7:00 AM EST
News source: Business Wire
Cyclacel Pharmaceuticals, Inc. (NASDAQ:CYCC) (NASDAQ:CYCCP)
announced that it has advanced sapacitabine into Phase 2 development
as a second-line treatment for myelodysplastic syndromes (MDS). The
MDS study is designed as a protocol amendment expanding the ongoing
Phase 2 trial of sapacitabine in elderly patients with acute myeloid
leukemia (AML) to include a cohort of patients with MDS. MDS are a
group of hematologic cancers in which the bone marrow becomes unable
to produce a sufficient number of healthy blood cells. Patients with
MDS often progress to AML.
"We have enrolled our first MDS patient under this expanded Phase
2 protocol," said Dr Judy Chiao, M.D., Vice President, Clinical
Development and Regulatory Affairs of Cyclacel. "An unmet medical need
exists for patients with MDS who progress after hypomethylating
agents, such as azacitidine or decitabine. In a Phase 1 study in
patients with advanced leukemias or MDS sapacitabine demonstrated
encouraging activity in MDS patients. Among four MDS patients with
aggressive disease that had progressed following azacitidine or
decitabine treatment, one achieved complete remission and two achieved
a decrease in bone marrow blast count to 5% or less. If similar
activity is observed in this Phase 2 study, sapacitabine could emerge
as an important treatment for this life-threatening disease."
Cyclacel is currently enrolling patients in an open-label,
multicenter, randomized Phase 2 trial of oral sapacitabine in elderly
patients with AML who are previously untreated or in first relapse.
Based on encouraging safety and efficacy data from the elderly AML
patients, Cyclacel has amended the protocol to include a cohort of MDS
patients who have been previously treated with hypomethylating agents.
Following the protocol amendment the trial will enroll a total of
approximately 120 patients in two separate strata, AML and MDS, with
approximately 60 patients in each stratum.
"Sapacitabine has previously demonstrated activity in MDS as well
as both forms of AML: AML de novo and AML preceded by MDS," commented
Spiro Rombotis, President and Chief Executive Officer of Cyclacel.
"Expanding our ongoing AML study to include an MDS stratum is a rapid
and cost effective strategy to obtain Phase 2 data in an important
second indication. We believe that this study design enhances the
commercial prospects of sapacitabine as it expands the drug's
potential market."
As with the original Phase 2 study in elderly patients with AML,
the primary objective of the MDS stratum is to evaluate the one-year
survival rate of three dosing schedules of sapacitabine. Secondary
objectives are to assess the number of patients who have achieved a
complete remission (CR), complete remission without blood count
recovery (CRi), hematological improvement and their corresponding
durations, transfusion requirements, number of hospitalization days
and safety. The study uses a selection design with the objective of
identifying a dosing schedule which produces a better one year
survival rate for each stratum in the event that all three dosing
schedules are active.
For more information on this study, please visit
www.clinicaltrials.gov.
About sapacitabine
Sapacitabine acts through a dual mechanism, interfering with DNA
synthesis by causing single-strand DNA breaks and inducing arrest of
cell cycle progression mainly at G2/M-Phase. Both sapacitabine and
CNDAC, its major metabolite, have demonstrated potent anti-tumor
activity in preclinical studies. Sapacitabine to date has been given
as a single agent to approximately 170 patients with both hematologic
malignancies and solid tumors in four Phase 1 studies. In an earlier
reported Phase 1 trial two treatment schedules of sapacitabine were
evaluated in 47 pretreated patients with advanced leukemias or MDS.
Six patients achieved complete remission or complete remission without
platelet count recovery and a further 15 achieved non-detectable
levels of leukemic blast cells in their bone marrow. In addition to
the Phase 2 study in elderly AML and MDS patients, sapacitabine is
being studied in a currently ongoing Phase 2 study in patients with
advanced cutaneous T cell lymphoma.
About Cyclacel Pharmaceuticals, Inc.
Cyclacel is a biopharmaceutical company dedicated to the
discovery, development and commercialization of novel,
mechanism-targeted drugs to treat human cancers and other serious
disorders. Three orally-available Cyclacel drugs are in clinical
development. Sapacitabine (CYC682), a cell cycle modulating nucleoside
analog, is in Phase 2 studies for the treatment of acute myeloid
leukemia in the elderly, myelodysplastic syndromes and cutaneous
T-cell lymphoma. Seliciclib (CYC202 or R-roscovitine), a CDK (cyclin
dependent kinase) inhibitor, is in Phase 2 for the treatment of lung
cancer and nasopharyngeal cancer and in Phase 1 in combination with
Tarceva(R). CYC116, an Aurora kinase and VEGFR2 inhibitor, is in Phase
1 in patients with solid tumors. Several additional programs are at an
earlier stage. Cyclacel's ALIGN Pharmaceuticals subsidiary markets
directly in the U.S. Xclair(R) Cream for radiation dermatitis,
Numoisyn(TM) Liquid and Numoisyn(TM) Lozenges for xerostomia.
Cyclacel's strategy is to build a diversified biopharmaceutical
business focused in hematology, oncology and other therapeutic areas
based on a portfolio of commercial products and a development pipeline
of novel drug candidates.
Please visit www.cyclacel.com for additional information. Note:
The Cyclacel logo and Cyclacel(R) are trademarks of Cyclacel
Pharmaceuticals, Inc.; Numoisyn(TM) and Xclair(R) are trademarks of
Sinclair Pharma plc; Tarceva(R) is a trademark of OSI Pharmaceuticals,
Inc.
Risk Factors
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, the risk that Cyclacel will not
obtain approval to market its products, 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. These factors and others are more fully
discussed under "Risk Factors" in the Annual Report on Form 10-K for
the year ended December 31, 2007, as supplemented by the interim
quarterly reports, filed with the SEC.
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