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 9, 2007
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:
[
]
Written communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
[
]
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
[
]
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange
Act
(17 CFR 240.14d-2(b))
[
]
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
January 9, 2007, the Company issued a press release, which is attached hereto
as
Exhibit 99.1 and is incorporated herein by reference.
Item
9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1 Press
Release dated January 9, 2007.
SIGNATURE
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: January 9, 2007 | By: | /s/ Richard E. Bagley |
|
Richard E. Bagley,
President,
Chief
Operating Officer and Chief Financial
Officer
|
||
Exhibit
Index
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Exhibit
No.
|
Description
|
|
|
99.1
|
Press
Release dated January 9, 2007
|
Exhibit
99.1
ZIOPHARM
Initiates ZIO-101 Phase II Study in Hematological Cancers
NEW
YORK, NY - January 9, 2007
-
ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP) announced today that ZIO-101, a novel,
proprietary organic arsenic, has been administered to the first patient in
a
phase II trial in blood and bone marrow cancers. Designed to confirm the
anti-cancer activity of ZIO-101 seen in the phase I hematological trial,
patients will receive intravenous ZIO-101 once daily for five consecutive days
every four weeks for up to six cycles. The Company anticipates enrolling up
to
40 patients at five U.S. clinical sites.
This
study complements an ongoing phase II trial to treat advanced multiple myeloma
in which the drug is administered using this same schedule as well as a second
trial with a schedule that is twice weekly for three consecutive weeks.
"Preclinical
and phase I trial results were very encouraging and demonstrated that ZIO-101
has anti-leukemia activity and may be an effective treatment in diverse blood
and bone marrow cancers,” said Robert Peter Gale, M.D., Ph.D., Senior Vice
President, Research at ZIOPHARM. “We anticipate this trial will further validate
the activity signals indicated from the phase I trials, and we look forward
to
advancing the clinical development of this novel, anti-cancer
drug.”
The
Company plans to initiate phase II trials with ZIO-101 in solid cancers in
Q1
2007 and expects to file an Investigational New Drug (IND) application for
a
phase I study with an oral formulation of ZIO-101. These programs are part
of
ZIOPHARM’s strategy to develop the full potential of this novel, small molecule,
anti-cancer drug
About
ZIO-101
ZIO-101
is a proprietary small molecule organic arsenic licensed from The University
of
Texas M. D. Anderson Cancer Center and Texas A&M University. ZIO-101 induces
cell cycle arrest and cell death by targeting several cellular pathways
essential for cell survival. Exposure to ZIO-101 has a direct as well as
indirect effect on mitochondrial functions, resulting in depletion of energy
supply to the cell and induction of apoptosis (programmed cell death). Increase
in intra-cellular Reactive Oxygen Species enhances this effect on mitochondrial
functions and consequently the activation of the signal transduction pathway
leading to apoptosis. In addition, ZIO-101 interrupts the cell cycle at the
G2/M
phase of tumor cells inducing cell death through this pathway as
well.
About
ZIOPHARM Oncology, Inc.
ZIOPHARM
Oncology, Inc. applies
new insights from molecular and cancer biology to understand the efficacy and
safety limitations of approved and developmental cancer therapies and identifies
proprietary and related molecules for better patient treatment.
For more information, visit www.ziopharm.com.
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.
ZIOP-G
Contacts:
Investors
Suzanne
McKenna
ZIOPHARM
Investor Relations
(646)
214-0703
smckenna@ziopharm.com
Media
Tina
Posterli
Rx
Communications
(917)
322-2565
tposterli@rxir.com