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): June 23, 2010
ZIOPHARM
Oncology, Inc.
(Exact
Name of Registrant as Specified in Charter)
Delaware
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001-33038
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84-1475642
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(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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1180
Avenue of the Americas
19th
Floor
New
York, NY
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10036
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(Address
of Principal Executive Offices)
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(Zip
Code)
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(646) 214-0700
(Registrant’s
telephone number, including area code)
Not
applicable
(Former
Name or Former Address, if Changed Since Last Report)
Check the
appropriate box below if the Form 8-K is intended to simultaneously satisfy
the filing obligation of the registrant under any of the following
provisions:
o
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Written
communications pursuant to Rule 425 under the Securities Act
(17 CFR 230.425).
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o
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12).
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o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR 240.14d-2(b)).
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o
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act
(17 CFR 240.13e-4(c)).
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Item 5.07 Submission of Matters to a Vote of
Security Holders.
The
registrant held its annual meeting of stockholders on June 23, 2010. At the
meeting, the registrant’s stockholders took the following actions:
(i) The
stockholders elected eight directors to serve as members of the registrant’s
Board of Directors until the next annual meeting of stockholders. The
stockholders present in person or by proxy cast the following numbers of votes
in connection with the election of directors, resulting in the election of all
director nominees:
Nominee
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Votes
For
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Votes
Withheld
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Jonathan
Lewis
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19,574,387
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23,383
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Richard
E. Bagley
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19,538,023
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59,747
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Murray
Brennan
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19,424,200
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173,570
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George
B. Abercrombie
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19,432,474
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165,296
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James
A. Cannon
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19,125,887
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471,883
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Wyche
Fowler, Jr.
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19,125,772
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471,998
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Timothy
McInerney
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19,013,318
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584,452
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Michael
Weiser
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19,043,240
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554,530
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(ii) The
stockholders approved an amendment to the registrant’s 2003 Stock Option Plan to
increase the number of shares of common stock reserved for issuance thereunder
from 6,002,436 shares to 9,002,436 shares. There were 18,116,517
votes cast for the proposal; 1,462,031 votes were cast against the proposal;
19,222 votes abstained; and there were 7,591,416 broker non-votes.
(iii) The
stockholders ratified the appointment of Caturano and Company, P.C. as the
independent registered public accounting firm of the registrant for fiscal 2010.
There were 26,065,966 votes cast for the proposal; 1,072,201 votes were cast
against the proposal; 51,019 votes abstained; and there were no broker
non-votes.
Item 8.01 Other
Events.
At the
annual meeting of stockholders, Dr. Jonathan Lewis, Chief Executive Officer of
the Registrant, provided a management presentation that included a discussion of
the Registrant’s planned pivotal Phase III trial for palifosfamide in metastatic
soft tissue sarcoma. As designed, the study is a randomized, double-blinded,
placebo-controlled, pivotal Phase III trial. Patients with metastatic soft
tissue sarcoma in the front-line setting will be randomized either to
doxorubicin plus placebo or to doxorubicin in combination with palifosfamide.
Progression-free survival is designated as the primary endpoint for accelerated
approval, while overall survival is the primary endpoint for full approval.
Based on communications with the U. S. Food and Drug Administration (FDA), the
Registrant announced its intention to conduct the pivotal trial as currently
designed and without obtaining Special Protocol Assessment (SPA) for the study.
The FDA previously
indicated that the Registrant could conduct the pivotal trial as designed
without SPA and its regulatory acceptability will depend on the magnitude of the
difference between study arms as well as with the risks and benefits. The study
design contemplates the enrollment of approximately 425 patients. The Registrant
expects enrollment in the trial to commence in the third quarter of 2010 and as
early as July 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 hereunto
duly authorized.
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ZIOPHARM
Oncology, Inc.
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By:
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/s/
Richard Bagley
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Date:
June 23, 2010
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Name:
Richard Bagley
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Title:
President, Chief Operating Officer and Chief Financial
Officer
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