- company to
initiate phase II Study in hematologic malignancies --
BERKELEY HEIGHTS, NJ, December 10, 2007 – Cyclacel Pharmaceuticals, Inc.
(NASDAQ: CYCC, NASDAQ: CYCCP) reported today updated results from a Phase I
clinical trial of sapacitabine (CYC682), a novel orally available nucleoside
analog, at the 49th Annual Meeting of the American Society of Hematology,
December 8 - 11, 2007 in Atlanta, Georgia. Data from this study demonstrated
that sapacitabine had a favourable safety profile and promising anti-leukemic
activity in patients with relapsed and refractory acute myelogenous leukemia
(AML) and myelodysplastic syndromes (MDS) when administered by two different
dosing schedules. Abstract No. 884
“The updated results of this study are impressive in terms of the observed
anti-leukemic activity and good tolerability of sapacitabine,” commented Dr.
Kantarjian, the study’s principal investigator. “I believe these promising
data warrant further clinical development of sapacitabine for the treatment of
AML and MDS.”
The primary objective of the study is to determine the maximum tolerated dose
(MTD) of sapacitabine administered twice daily for seven consecutive days
every 21 days or three consecutive days per week for two weeks every 21 days.
The MTD was reached at 375 mg on the seven-day schedule and 475 mg on the
3-day schedule. Dose-limiting toxicity was gastrointestinal which included
abdominal pain, diarrhoea, small bowel obstruction and neutropenic colitis.
One patient treated at the MTD of 375 mg on the seven-day schedule died of
complications from neutropenic colitis. Among 46 patients with AML (n=42) or
MDS (n=4) in this dose escalating study, the best responses were complete
remissions (CR) or complete remissions without platelet recovery (CRp) in six
patients. In addition, 15 patients had a significant decrease in bone marrow
blasts including seven with blast reduction to 5% or less.
The study is ongoing at The University of Texas M. D. Anderson Cancer Center
and is led by Dr. Hagop Kantarjian, Professor of Medicine and Chairman of the
Leukemia Department and Dr. William Plunkett, Professor and Chief, Section of
Molecular and Cellular Oncology, Department of Experimental Therapeutics.
Based on the encouraging anti-leukemic activity observed in this study,
Cyclacel plans to open a multicenter randomized Phase II clinical trial later
this month of oral sapacitabine in elderly patients with acute myeloid
leukemia who are previously untreated or in first relapse. The primary
objective of this study is to evaluate the one-year survival rate of three
dosing schedules. The study will use a selection design to identify a dosing
schedule that produces a better one-year survival rate in the event that all
three dosing schedules are active.
To receive a copy of Cyclacel’s ASH Abstract, please reply to this email or
email Cyclacel@collegehill.com
- ENDS -
About Sapacitabine
Sapacitabine appears to act through a dual mechanism. It interferes with DNA
synthesis by causing single-strand DNA breaks and also induces arrest of cell
cycle progression mainly at G2/M-Phase. Both sapacitabine and CNDAC, its major
metabolite or a substance into which the drugs converts after ingestion by
patients, have demonstrated potent anti-tumor activity in preclinical studies.
In addition, in a mouse model of liver metastasis, sapacitabine was shown to
be superior in terms of delaying the onset and growth of liver metastasis to
either gemcitabine (Gemzar®; Lilly) or 5-FU, two widely used nucleoside
analogs. Gemcitabine is indicated for the palliative treatment of breast,
lung, ovarian and pancreatic cancer, but it has not been reported to be active
in leukemias or MDS.
The reported study follows three Phase I trials in solid tumors or lymphomas
involving over 120 patients which evaluated safety and pharmacokinetics of a
variety of dosing schedules for future Phase II studies and combination
studies with other anti-cancer agents. A Phase II study of sapacitabine in
patients with advanced cutaneous T cell lymphoma is currently ongoing.
Sapacitabine is part of a deep pipeline of small molecule drugs designed to
target and stop uncontrolled cell division. Cyclacel’s other development
programs include seliciclib, a CDK (cyclin dependent kinase) inhibitor in two
randomized Phase II clinical trials for non-small cell lung cancer and
nasopharyngeal cancer, and CYC116, an Aurora kinase and VEGFR2 inhibitor in
Phase I development in patients with solid tumors.
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. Cyclacel’s ALIGN Pharmaceuticals
subsidiary markets directly in the U.S. Xclair® Cream for radiation
dermatitis, Numoisyn® Liquid and Numoisyn® Lozenges for xerostomia. Three
Cyclacel drugs are in clinical development. Sapacitabine (CYC682), an
orally-available, cell cycle modulating nucleoside analog, is in Phase II for
the treatment of cutaneous T-cell lymphoma (CTCL) and in Phase I in patients
with hematologic malignancies. Seliciclib (CYC202), an orally-available CDK (cyclin
dependent kinase) inhibitor, is in two randomized Phase II studies for the
treatment of lung cancer and nasopharyngeal cancer. CYC116, an
orally-available, Aurora kinase and VEGFR2 inhibitor, is in Phase I
development in patients with solid tumors. Several additional programs are at
an earlier stage. Cyclacel’s strategy is to build a diversified
biopharmaceutical business focused in oncology, hematology and other
therapeutic areas based on a portfolio of commercial products and a
development pipeline of novel drug candidates.
Please visit
http://www.cyclacel.com/cyc/investors/news/pressreleases for
additional information
Note: The Cyclacel logo and Cyclacel® are trademarks of Cyclacel
Pharmaceuticals, Inc. Numoisyn® and Xclair® are trademarks of Sinclair Pharma
plc.
Forward-Looking Statements & 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, 2006, as supplemented by the interim
quarterly reports, filed with the SEC.
Contacts for Cyclacel:
European Media and Investor Relations
College Hill Life Sciences
Ph: +44 (0)20 7866 7857
Cyclacel@collegehill.com
