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 5, 2008
ZIOPHARM
Oncology, Inc.
(Exact
Name of Registrant as Specified in its Charter)
|
Delaware
|
0-32353
|
84-1475642
|
|
(State
or Other Jurisdiction of Incorporation)
|
(Commission
File Number)
|
(IRS
Employer Identification No.)
|
1180
Avenue of the Americas, 19th Floor
New
York, NY 10036
(Address
of Principal Executive Offices) (Zip Code)
(646)
214-0700
(Registrant’s
telephone number, including area code)
(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 5, 2008, ZIOPHARM Oncology, Inc. issued the press release attached
hereto as Exhibit 99.1, which is incorporated herein by
reference.
Item
9.01. Financial Statements and Exhibits.
| (d) |
Exhibits.
|
| 99.1 |
Press
Release dated September 5, 2008.
|
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.
ZIOPHARM
Oncology, Inc.:
(Registrant)
Date:
September 8, 2008
By:
/s/
Richard E. Bagley
Name:
Richard
E. Bagley
Title:
President
and Chief Operating Officer
Exhibit
99.1
ZIOPHARM
COMMENCES RANDOMIZED PHASE II STUDY OF PALIFOSFAMIDE IN SOFT TISSUE
SARCOMA
NEW
YORK
- September 05, 2008 - ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP), announced today
that the first patient has been dosed in its international Phase II randomized
controlled trial of palifosfamide (ZIO-201) in patients with soft-tissue sarcoma
(STS): This is a Phase
II
multi-center, parallel group, randomized study of palIfosfamide
plus doxorubicin versus doxorubiCin
in
subjects with unresectAble
or
metastatic Soft-tissue
SarcOma
(PICASSO).
Approximately 100 evaluable subjects are expected to be enrolled in this
multi-center trial, which is being conducted at sites in the U.S. and Europe
by
several key opinion leaders in sarcoma.
This
Phase II trial will evaluate the clinical benefit of palifosfamide administered
with doxorubicin compared with single-agent doxorubicin in subjects diagnosed
with unresectable or metastatic STS in the front- or second-line treatment
setting. The primary endpoint is assessment of the difference in
progression-free survival between subjects in the two arms of the trial.
Sant
P.
Chawla, M.D., Director, Sarcoma Oncology Center, Santa Monica, and one of the
lead investigators of the study noted, “I am delighted to announce the dosing of
the first patient in this key combination trial for palifosfamide in front-
and
second-line patients following very promising results in previous trials in
sarcoma in the refractory setting. By conducting a randomized controlled Phase
II trial where the primary endpoint is progression-free survival, ZIOPHARM
has
optimized its chances of yielding positive results by aiding in the design
and
thereby mitigating risk for a Phase III pivotal trial to follow.”
In
May
2008, ZIOPHARM received Orphan Drug Designation from the U.S. Food and Drug
Administration (FDA) for palifosfamide in the treatment of STS. For more details
about this trial, please see www.clinicaltrials.gov.
About
ZIOPHARM Oncology, Inc.
ZIOPHARM
Oncology is
a
biopharmaceutical company engaged in the development and commercialization
of a
diverse portfolio of cancer drugs. The Company is currently focused on the
development of three clinical programs for multiple indications. Palifosfamide
(ZIO-201) is a novel molecule that is the functional active metabolite of
ifosfamide, a standard of care for treating sarcoma, testicular cancer and
other
cancers. Palifosfamide delivers only the cancer fighting component of
ifosfamide. It overcomes the resistance of ifosfamide and cyclophosphamide
in
certain cancers. It does not have the toxic metabolites that cause the
debilitating side effects of “fuzzy brain” (encephalopathy) and severe bladder
inflammation. Indibulin (ZIO-301) is
a
novel, oral tubulin binding agent that targets both mitosis and cancer
cell
migration.
Indibulin has several potential benefits, including oral dosing, application
in
multi-drug resistant tumors, no neuropathy and minimal overall
toxicity.
Indibulin
has shown early activity in many types of solid tumors. Darinaparsin
(ZIO-101) is
a
novel organic arsenic being developed for the treatment of various hematologic
and solid cancers. Studies demonstrate that darinaparsin is less toxic and
more
active in treating cancer than FDA-approved inorganic arsenic. ZIOPHARM’s
operations are located in Boston MA with an executive office in New
York.
Further
information about ZIOPHARM may be found at www.ziopharm.com.
ZIOP-G
Forward-Looking
Safe Harbor Statement:
This
press release contains forward-looking statements for ZIOPHARM Oncology, Inc.
that involve risks and uncertainties that could cause the Company's actual
results to differ materially from the anticipated results and expectations
expressed in these forward-looking statements. These statements are based on
current expectations, forecasts and assumptions that are subject to risks and
uncertainties, which could cause actual outcomes and results to differ
materially from these statements. Among other things, there can be no assurance
that any of the Company's development efforts relating to its product candidates
will be successful, or such product candidates will be successfully
commercialized. Other risks that affect forward-looking information contained
in
this press release include the possibility of being unable to obtain regulatory
approval of the Company's product candidates, the risk that the results of
clinical trials may not support the Company's claims, and risks related to
the
Company's ability to protect its intellectual property and its reliance on
third
parties to develop its product candidates. The Company assumes no obligation
to
update these forward-looking statements, except as required by law.
#
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Contacts:
Suzanne
McKenna
ZIOPHARM
Oncology, Inc.
(646)
214-0703
smckenna@ziopharm.com