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): September 13, 2010
CYCLACEL PHARMACEUTICALS, INC.
(Exact name of registrant as specified in its charter)
| Delaware | 0-50626 | 91-1707622 | ||
| (State or other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
| 200 Connell Drive, Suite 1500 Berkeley Heights, NJ |
07922 | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s telephone number, including area code: (908) 517-7330
| (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))
Item 8.01 Other Events
On September 13, 2010, Cyclacel Pharmaceuticals, Inc. (the “Company”) issued a press release announcing that it has reached agreement with the U.S. Food and Drug Administration regarding a Special Protocol Assessment on the design of a pivotal Phase 3 trial for the Company’s sapacitabine oral capsules as a front-line treatment in elderly patients aged 70 years or older with newly diagnosed acute myeloid leukemia who are not candidates for intensive induction chemotherapy. A copy of the press release is attached as Exhibit 99.1.
| Item 9.01 |
Financial Statements and Exhibits
|
| (d) |
The following exhibit is furnished with this Report:
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Exhibit No.
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Description | |
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99.1
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Press Release dated September 13, 2010 |
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 President—Finance, Chief Financial Officer and Chief Operating Officer |
Date: September 13, 2010