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): January 13, 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 January 13, 2009, Cyclacel Pharmaceuticals, Inc., a Delaware corporation (the Company), issued a press
release announcing that the Company has begun a Phase 2 clinical trial of oral sapacitabine (CYC682) in patients with
previously treated, non-small cell lung cancer.
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.
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Number |
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Description |
99.1
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Press release, dated January 13, 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: January 13, 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 January 13, 2009 |
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Filed by Bowne Pure Compliance
Exhibit 99.1
Cyclacel begins Phase 2 study of oral sapacitabine in patients with previously treated non-small
cell lung cancer
Cyclacel begins Phase 2 study of oral sapacitabine in patients with previously treated non-small
cell lung cancer BERKELEY HEIGHTS, NJ January 13, 2009 Cyclacel Pharmaceuticals, Inc.
(NASDAQ: CYCC, NASDAQ: CYCCP) announced today that the company has begun treating patients in a
Phase 2, open label, single arm, multicenter clinical trial of sapacitabine (CYC682) in patients
with non-small cell lung cancer (NSCLC) who have had one prior chemotherapy. This study builds on
the observation of prolonged stable disease of four months or longer experienced by heavily
pretreated NSCLC patients involved in two Phase 1 studies of sapacitabine. The multicenter Phase 2
trial is led by Philip D. Bonomi, M.D., the Alice Pirie Wirtz Professor of Medical Oncology at the
Rush University Medical Center, Chicago.
Nucleoside analogs, such as gemcitabine, have significant activity in NSCLC said Dr. Bonomi. We
are interested in evaluating sapacitabine because of its unique mechanisms of action, indication of
activity in Phase 1 studies and the possibility that it may be an active drug in NSCLC that can be
administered by the oral route.
The primary objective of the study is to evaluate the rate of response and stable disease in
patients with previously treated NSCLC. Secondary objectives are to assess progression-free
survival, duration of response, duration of stable disease, one year survival, overall survival and
safety. The study will enroll approximately 60 patients and has a lead-in phase for dose escalation
with the objective of defining a recommended dose followed by a second stage in which patients will
be treated at the recommended dose. Study completion is planned to occur approximately six months
after the last patient is enrolled.
The opening of this study marks the expansion of the Phase 2 program of sapacitabine into solid
tumors, said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. We believe that
sapacitabine has the potential to emerge as a novel, orally-administered treatment for patients
with both hematologic malignancies and solid tumors. During this quarter Cyclacel will meet with
the US FDA to discuss registration pathways for sapacitabine as a treatment for acute myeloid
leukemia (AML) or myelodysplastic syndromes (MDS) in elderly patients.
About sapacitabine
Cyclacel is now evaluating sapacitabine, an orally available nucleoside analog, in three Phase 2
trials in both hematological and solid tumors. 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 has been given as a
single agent to approximately 170 patients with both hematologic malignancies and solid tumors in
four Phase 1 studies. In Phase 1 trials reported earlier sapacitabine was evaluated in 47
pretreated patients with advanced leukemias or MDS and 123 heavily-pretreated patients with various
solid tumors. In the hematological malignancy trial six patients achieved complete remission or
complete remission without platelet count recovery and a further 15 had a significant decrease in
bone marrow blasts including 7 with blast reduction to 5% or less. In the solid tumor studies, 20
patients experienced prolonged stable disease and remained on study for four months or longer, five
with NSCLC, one with small cell lung cancer, four with colorectal, two with bladder, two with
gastrointestinal stromal tumors, two with ovarian, one with breast, one with renal, one with
parotid and one with an unknown primary tumor. Sapacitabine is also being studied in a currently
ongoing Phase 2 trial 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, 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. Several additional programs are at
an earlier stage. 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 |