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): October 25, 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:
| 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
October 25, 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 October 25, 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: October 25, 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 October 25, 2007.
|
Exhibit
99.1
Clinical
and Preclinical Data for Oral Indibulin (ZIO-301) Presented at AACR/NCI/EORTC
Conference
Unique
Targeting Mechanism; Translation to Early Clinical Activity without
Neurotoxicity
SAN
FRANCISCO - October 25, 2007
-
ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP) announced today the presentation of
two
posters reporting clinical and pre-clinical data for the oral
administration of indibulin (ZIO-301) at the Molecular Targets and Cancer
Therapeutics Conference, an international conference hosted by the American
Association for Cancer Research (AACR), the National Cancer Institute (NCI)
and
the European Organization for Research and Treatment of Cancer (EORTC) being
held in San Francisco, California, from October 22-26, 2007.
Data
presented in two separate posters, “Indibulin
(ZIO-301): An Orally Active Tubulin Polymerization Inhibitor with a Unique
Molecular Mechanism of Action” and
“Translation
of Indibulin (ZIO-301) Preclinical Antiangiogenic and Antimetastatic Activity
to
the Clinic,” highlight
indibulin’s unique molecular mechanism and the demonstration of
early clinical activity in the recently initiated U.S. phase I study in
various tumor types.
Preclinical
data show indibulin to have a potent, and uniquely targeted antitumor activity
as a single agent. Indibulin has a unique molecular mechanism and targets
specific subsets in cellular microtubules, altering the apical recycling
endosome while not affecting acetylated tubulin or the Golgi. In cell
lines, indibulin has potent synergistic activity in combination with several
approved cancer drugs. The strongest synergy was observed in a non-small cell
lung cancer cell line (NSCLC) with erlotinib (Tarceva®), which is an epidermal
growth factor receptor inhibitor. Indibulin also enhanced the effect of
carboplatin in the same cell line.
In
the
recently initiated U.S. phase I dose escalation study of indibulin, data is
reported on the first three patients who have been treated with 400 mg twice
daily on a continuous dosing schedule. Two of these patients have shown
activity. An elderly patient with metastatic papillary thyroid cancer evidenced
stable disease with an 11% decrease in tumor measurements and 34% decrease
in
thyroglobulin levels early in treatment. A patient with ovarian cancer and
brain metastases showed an 11% reduction of CA125 levels from baseline, also
after early treatment. The study continues to escalate the dosing
level and, indibulin treatment has not demonstrated the neurotoxicities commonly
associated with all other microtubulin inhibitors.
Commenting
on the findings, James R. Goldenring, M.D., Ph.D., Paul W. Sanger Professor
and
Vice-Chairman for Research at Vanderbilt School of Medicine, Ingram Cancer
Center, and a senior co-investigator said, “These data suggest that indibulin
has a unique molecular mechanism, targeting specific subsets in cellular
microtubules and likely in a cell-specific manner. This unique
mechanism may account for its potent oral single-agent antitumor activity and
its high synergy with a number of widely used anticancer agents. When
viewed with the lack of neurotoxicity in the phase I trials to date, these
data
would strongly support successful clinical translation in upcoming phase II
studies both as a single agent and in combination with established
chemotherapeutics.”
Dr.
Brian
Schwartz, MD, Chief Medical Officer, concluded, “These encouraging data are
important in that they further elucidate Indibulin’s unique and exciting cell
biology and support our ongoing clinical development program to further evaluate
its utility as a single agent and in combination with widely-used anticancer
agents. The clinical activity demonstrated in patients in our ongoing
phase I study is most encouraging especially as the drug is well tolerated
and
lacks the neurotoxicities commonly associated with other anticancer
agents. We look forward to completing these studies and to reporting the
data in the near future.”
About
ZIO-301
ZIO-301
(indibulin) 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 the U.S. and Europe. The Company expects to begin U.S.
phase
II trials in 2008.
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.