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): August 4, 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
August
4, 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 August 4, 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: August 4, 2008 | By: | /s/ Richard E. Bagley |
|
Name: Richard E. Bagley |
||
|
Title:
President and Chief Operating
Officer
|
||
Exhibit
99.1
Leukemia
Journal Publishes Results from Darinaparsin Study
Study
Suggests Potentially Broader Therapeutic Spectrum for Darinaparsin than
Inorganic Arsenic
New
York,
NY, August 04, 2008 - ZIOPHARM Oncology, Inc. (NASDAQ:ZIOP) announced today
the
publication of results from a pre-clinical study
of
darinaparsin (ZIO-101) in the July 17, 2008 on line advance publication issue
of
Leukemia,
a
Nature
publication. The article, titled "A novel arsenical has antitumor activity
toward As2O3-resistant
and MRP1/ABCC1-
overexpressing cell lines," was led by Wilson Miller, M.D., Ph.D., Professor,
Medicine and Oncology, McGill University-Jewish General Hospital in Montreal,
Canada.
The
study
showed that darinaparsin is highly active in
vitro
against
certain leukemia cells that are resistant to inorganic arsenic (arsenic
trioxide—ATO) because they express a drug resistance protein (MRP1/ABCC1). This
greater antitumor activity was demonstrated through the more potent induction
of
oxidative stress and programmed cell death (apoptosis). It also correlated
with
substantially greater accumulation of arsenic in darinaparsin-treated leukemia
cells than those treated with inorganic arsenic, possibly because inorganic
arsenic is more efficiently exported by the drug resistance
proteins.
The
study
also demonstrated that darinaparsin triggers apoptosis by inducing signaling
pathways that do not completely overlap with ATO. Whereas both darinaparsin
and
ATO act via the Jun kinase (JNK) pathway, darinaparsin
did
not depend on mechanisms normally associated with ATO’s therapeutic activity,
including the degradation of the promyelocytic leukemia/retinoic acid receptor
α
(PML/RARα) oncoprotein and rearrangement of PML nuclear bodies.
“This
study suggests that darinaparsin may have a broader therapeutic spectrum than
inorganic arsenic, as it is less affected by the resistance mechanisms of
certain cancer cells,” stated Dr. Miller. “The successful application of a
treatment that offers inorganic arsenic’s efficacy in acute promyelocytic
leukemia, to other more common malignancies, would be significant. I look
forward to seeing more data from ongoing clinical and pre-clinical
studies.”
About
Darinaparsin
Darinaparsin
is a proprietary small molecule organic arsenic licensed from The University
of
Texas M. D. Anderson Cancer Center and Texas A&M University. Darinaparsin
induces cell cycle arrest and cell death by targeting several cellular pathways
essential for cell survival. Exposure to darinaparsin 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, darinaparsin interrupts the cell cycle at
the
G2/M phase of tumor cells inducing cell death through this pathway.
About
ZIOPHARM Oncology, Inc.
ZIOPHARM
Oncology, Inc. is a biopharmaceutical company engaged in the development and
commercialization of a diverse, risk-sensitive portfolio of in-licensed cancer
drugs to address unmet medical needs. The
Company 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
Contact:
Suzanne
McKenna
ZIOPHARM
Oncology, Inc.
(646)
214-0703
smckenna@ziopharm.com
or
Andrea
Rabney
Argot
Partners
(212)
600-1902
andrea@argotpartners.com