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 10, 2007
ZIOPHARM
Oncology, Inc.
(Exact
name of registrant as specified in its charter)
|
Delaware
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0-32353
|
84-1475642
|
|
(State
or other jurisdiction of incorporation)
|
(Commission
File Number)
|
(IRS
Employer Identification No.)
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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))
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Item
8.01. Other Events.
On
September 10, 2007, 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 10, 2007.
1
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.
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ZIOPHARM
Oncology,
Inc.:
(Registrant)
|
||
| |
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| Date: September 11, 2007 | By: | /s/ Jonathan Lewis |
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JONATHAN LEWIS, |
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| Chief Executive Officer | ||
2
Exhibit
Index
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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 10, 2007.
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3
ZIOPHARM
Treats Patients in U.S. Phase I Trials of Oral Darinaparsin and Indibulin
Company
Receives First Notice of Allowance for Oral Darinaparsin
Patent
NEW
YORK (September 10, 2007)
-
ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP) announced today that the company has
begun dosing patients in a U.S. phase I trial of its oral formulation of
darinaparsin (ZIO-101) to treat solid tumors. The Company has also initiated
patient treatment in a U.S. phase I trial of the oral formulation of indibulin
(ZIO-301) in solid tumors. The Company’s strategy is to pursue oral formulations
for all of their compounds as oral formulations may offer considerable
advantages over infusion formulations including patient convenience, cost
savings, and commercial benefit.
Separately,
the Company announced that Australia has determined that certain patent claims
for darinaparsin (ZIO-101), the Company’s proprietary organic arsenic, are in
condition for allowance. These claims will cover treatment of cancer using
organic arsenic, including darinaparsin, as single agents and in combination
with other agents or therapies. Most importantly the claims will cover all
oral
formulations of organic arsenic.
The
Company also announced the expansion of the intellectual property portfolio
covering indibulin (ZIO-301) and its use in the treatment of cancer by the
allowance of claims in India, Turkey and Iceland and the recent issuance of
patents in Israel and Slovakia.
Jonathan
Lewis, M.D., Ph.D., Chief Executive Officer of ZIOPHARM, commented, “We were
especially pleased to initiate patient dosing in our two U.S. phase I trials
of
the oral formulations of darinaparsin and indibulin as we believe each compound
may hold significant clinical and commercial potential as both single agents
and
in combination with other oncology therapies. ”
“The
new
patents and allowances for both darinaparsin and indibulin add significantly
to
our growing intellectual property portfolio,” concluded Dr. Lewis.
About
Darinaparsin (ZIO-101)
Darinaparsin
is a proprietary, small-molecule organic arsenic licensed exclusively to
ZIOPHARM 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 pathways
leading to apoptosis. In addition, darinaparsin arrests the cell cycle at the
G2/M phase of tumor cells, causing cell death by this pathway also.
ZIOPHARM
is enrolling patients in two ongoing phase II studies evaluating the preliminary
efficacy and safety profile of different treatment schedules of darinaparsin
(ZIO-101) in patients with advanced/progressive myeloma (patients to date have
had a median of seven prior therapies). ZIOPHARM is also enrolling patients
in
phase II trials of darinaparsin for the treatment of primary liver cancer and
diverse hematological cancers. Phase I trial with an oral form of darinaparsin
has been initiated. For more details on these trials please see www.clinicaltrials.gov.
About
Indibulin (ZIO-301)
Indibulin
(ZIO-301) is a novel synthetic anti-mitotic agent that binds to tubulin,
destabilizes microtubule polymerization, and arrests tumor cell growth at the
G2/M phase. Microtubules are well-established targets for anti-cancer drug
development and tubulin-binding drugs such as taxanes and vinca
alkaloids are currently widely used to treat cancer. Indibulin is in a Phase
I
dose-ranging and safety study in Europe and the United States. The Company
expects to begin Phase II trials in the U.S. soon.
About
ZIOPHARM Oncology
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
Statements
This
news
release contains forward-looking statements based on current expectations,
forecasts and assumptions that are subject to risks and uncertainties that
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
that such product candidates will be successfully commercialized. Other risks
that affect forward-looking information contained in this news 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. For further risk factors see the
Company's 10-KSB filed with the SEC.
ZIOP-G
CONTACTS:
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Investors:
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Media:
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ZIOPHARM
Oncology, Inc.
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Rx
Communications
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Suzanne
McKenna, Investor Relations
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Tina
Posterli
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646-214-0703
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917-322-2565
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smckenna@ziopharm.com
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tposterli@rxir.com
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