Filed by Bowne Pure Compliance
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): February 6, 2009
CYCLACEL PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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0-50626 |
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91-1707622 |
(State or other Jurisdiction of Incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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200 Connell Drive Suite 1500 Berkeley Heights, NJ
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07922 |
(Address of Principal Executive Offices) |
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(Zip Code) |
Registrants telephone number, including area code: (908) 517-7330
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(Former name or former address if changed since last report.) |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant
under any of the following provisions:
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
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Item 8.01 Other Events.
On February 6, 2009, Cyclacel Pharmaceuticals, Inc., a Delaware corporation (the Company), issued a press
release announcing progress in a pivotal trial plan for sapacitabine, its oral nucleoside analogue, for the treatment
of hematological malignancies. The announcement follows the Companys recent meeting with the U.S. Food and Drug
Administration (FDA).
The full text of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is
incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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Number
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Description |
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99.1
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Press release, dated February 6, 2009 |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to
be signed on its behalf by the undersigned thereunto duly authorized.
CYCLACEL PHARMACEUTICALS, INC.
By: /s/ Paul McBarron
Name: Paul McBarron
Title: Executive Vice PresidentFinance and
Chief Operating Officer
Date: February 6, 2009
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EXHIBIT INDEX
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Exhibit No. |
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Description |
99.1
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Press Release, dated February 6, 2009 |
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Filed by Bowne Pure Compliance
Exhibit 99.1
CYCLACEL PHARMACEUTICALS ADVANCES ORAL SAPACITABINE
PIVOTAL TRIAL PLAN IN HEMATOLOGICAL MALIGNANCIES
BERKELEY HEIGHTS, NJ February 6, 2009 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ:
CYCCP) announced today progress with a pivotal trial plan for sapacitabine, its oral nucleoside
analogue, for the treatment of hematological malignancies. The announcement follows the companys
recent meeting with the U.S. Food and Drug Administration (FDA).
The pivotal trial plan consists of treating in an open-label, single arm study approximately 100
patients with acute myeloid leukemia (AML) or myelodysplastic syndromes (MDS) on a dosing regimen
to be selected from the currently ongoing randomized Phase 2 study of oral sapacitabine in elderly
patients. The company anticipates that it will start enrolling patients in such a pivotal study
within 2009. Efficacy and safety in a total of approximately 200 patients with leukemias or MDS
will be required to provide information for the label in a future submission of a New Drug
Application (NDA).
We are gratified by the advice offered by the FDA on our proposed plan. Results of this pivotal
study, if positive, may serve as the basis of an NDA filing and may support expanded investigation
of sapacitabine in additional indications, said Spiro Rombotis, Cyclacels President and CEO. We
will require additional meetings and dialogue with FDA before any NDA filing. Available data from
our ongoing Phase 2 studies of sapacitabine include complete remissions at all doses tested with
good tolerability, support previously-reported Phase 1 findings and suggest that this agent may
address a substantial, unmet medical need in older patients with AML and MDS. We thank our
clinical investigators, their staff and patients for helping us reach this important milestone.
Sapacitabine is currently being studied 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
with the objective of evaluating three dosing schedules. Based on encouraging efficacy and safety
data from the elderly AML patients, Cyclacel amended the protocol in 2008 to include a cohort of
MDS patients who have been previously treated with hypomethylating agents. Following the protocol
amendment the Phase 2 trial is anticipated to enroll a total of approximately 120 patients in two
separate strata, AML and MDS, with approximately 60 patients in each stratum.
Cyclacel expects to report interim data from ongoing Phase 2 studies at upcoming major scientific
meetings.
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. Data from a Phase 1
dose-escalation trial of sapacitabine were presented in December 2007 at the American Society of
Hematology annual meeting. Two treatment schedules of sapacitabine were assessed in 47 evaluable,
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 currently ongoing Phase 2 studies in patients with
advanced cutaneous T cell lymphoma and non-small cell lung cancer.
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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, cutaneous T-cell lymphoma and
lung cancer. Seliciclib (CYC202 or R-roscovitine), a CDK (cyclin dependent kinase) inhibitor, is in
Phase 2 for the treatment of lung cancer and nasopharyngeal cancer. CYC116, an Aurora kinase and
VEGFR2 inhibitor, is in Phase 1 in patients with solid tumors. Cyclacels ALIGN Pharmaceuticals
subsidiary markets directly in the U.S. Xclair® Cream for radiation dermatitis,
Numoisyn® Liquid and Numoisyn® Lozenges for xerostomia. Cyclacels 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® are trademarks of Cyclacel Pharmaceuticals, Inc. Numoisyn® and
Xclair® are trademarks of Sinclair Pharma plc.
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 Cyclacels 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.
Contacts for Cyclacel:
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Cyclacel Pharmaceuticals, Inc.
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WeissComm Partners
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College Hill, Life Sciences |
Corey Sohmer
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Aline Schimmel
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Sue Charles & Justine Lamond |
(908) 517-7330
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(312) 646-6295
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+44 (20) 7866 7857 |