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): July 23, 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
July
23, 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 July 23, 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)
|
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||
| |
|
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| Date: July 23, 2008 | By: | /s/ Richard E. Bagley |
| Name: | Richard E. Bagley | |
| Title: | President and Chief Operating Officer | |
Exhibit
99.1
ZIOPHARM
Presents Safety and Preliminary Efficacy Data from Two
Phase
I Studies of Indibulin at AACR Centennial Conference
Studies
Demonstrate Indibulin is Well Tolerated and
Shows
Early Activity in Several Tumor Types
Monterey,
CA, July 23, 2008 -
ZIOPHARM Oncology, Inc. (NASDAQ:ZIOP) announced today that it presented data
from two Phase I studies of indibulin, the Company’s novel, orally administered,
synthetic tubulin targeted agent, at the American Association for Cancer
Research (AACR) Centennial Conference on Translational Cancer Medicine 2008:
Cancer Clinical Trials and Personalized Medicine held in Monterey, California,
July 20 to 23, 2008.
A
total
of 34 patients have been treated in the two Phase I studies (Phase I and Phase
Ib), and safety, tolerability and early activity are being evaluated from
varying doses and dose schedules. Study patients presented with sarcomas and
a
variety of carcinomas, including pancreatic, thyroid, ovarian, prostate and
lung
cancers. To date, 24 patients have received at least two cycles of therapy
and
are evaluable for efficacy using RECIST criteria. Of these, prolonged stable
disease of greater than 4 months has been observed in 11 patients, with 3 of
these patients reaching eight or more months to date. In addition, early PET
scans have demonstrated 1 complete reduction in uptake, 6 with partial reduction
in uptake, and 4 with increased uptake. Tumor responses measured by PET scan
are
generally referred to as metabolic responses, and usually correlate with
treatment responses in cancer. The most common study drug-related toxicities
reported were mild to moderate fatigue, nausea, diarrhea and anorexia. Unlike
studies of other microtubule targeting agents, no neurotoxicity and minimal
bone
marrow suppression were observed.
“Early
data suggests that indibulin is clearly active in a number of cancers, and
maintains a toxicity profile that distinguishes it from other tubulin binding
agents such as the taxanes and vinca alkaloids,” said Sant P. Chawla, M.D.,
Director, Sarcoma Oncology Center, Santa Monica, and a lead investigator of
the
study. “Notably, the common and serious side effects typically associated with
this class of therapy have not been observed. We look forward to seeing
indibulin developed in tumor specific studies.”
For
more
details on these trials please see www.clinicaltrials.gov.
About
Indibulin
Indibulin
is a novel synthetic anti-mitotic agent that binds to tubulin, destabilizes
microtubule polymerization, arrests tumor cell growth at the G2/M phase and
inhibits cell mobility and metastasis. 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 orally
available, lacks neurotoxicity and has efficacy in taxane refractory preclinical
models.
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