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): March 20, 2008
ZIOPHARM
Oncology, Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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0-32353
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84-1475642
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(State
or other jurisdiction of incorporation)
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(Commission
File Number)
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(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:
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o
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Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
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o
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR
240.14d-2(b))
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o
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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
March
20, 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.
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(d)
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Exhibits.
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99.1
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Press
Release dated March 20, 2008.
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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.:
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(Registrant)
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Date:
March 20, 2008
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By: |
/s/
Richard E. Bagley
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Richard
E. Bagley,
President,
Chief Operating Officer and Chief Financial
Officer
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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 March 20,
2008.
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Exhibit
99.1
ZIOPHARM
Presents Promising Early Data from Phase Ib Study of Indibulin at 6th
International Symposium on Targeted Anticancer Therapies
Results
Shows Indibulin Is Well Tolerated and Active
Among
Eight Evaluable Patients
Bethesda,
MD, March 20, 2008-
ZIOPHARM Oncology, Inc. (NASDAQ:ZIOP) announced today that it presented
promising early data from a Phase Ib study of indibulin, the Company’s novel,
orally administered, synthetic tubulin targeted agent, at the 6th
International Symposium on Targeted Anticancer Therapies held in Bethesda,
Maryland, March 20 to 22.
A
total
of 14 patients with a variety of cancers, including sarcomas and carcinomas,
have been treated to date in the study. Following a total of 30 cycles of
treatment, indibulin has been shown to be very well tolerated, with no
drug-related Grade 2 or higher toxicities reported. Of note, no
neurotoxicities, a common and serious side effect typically associated
with
microtubule targeting agents, have been observed.
In
addition to confirming indibulin’s safety profile, this study evaluates early
treatment responses by PET scans. Among 8 evaluable patients, these PET
scans
demonstrated a substantial anti-tumor effect by indibulin. Week 7 PET
scans identified 1 complete reduction in uptake, 4 with partial reduction
in
uptake, and 3 with increased uptake. Tumor responses measured by PET
scan are generally referred to as metabolic responses, and usually correlate
with treatment responses in cancer.
“Safely
and effectively targeting microtubules in cancer cells has long been a
goal of
researchers as it leads to a variety of anti-cancer activity, including
antiangiogenesis and antimetastasis,” commented Sant P. Chawla, MD, Director,
Sarcoma Oncology Center and a lead investigator of the study. “Yet to
date, these agents have all demonstrated serious side effects. Oral
indibulin, by contrast, has been very well tolerated, with none of the
neurotoxicity or bone marrow suppression seen with taxanes and vinca
alkaloids. Indibulin has also demonstrated promising early activity by PET
scan, including a complete response in Ewing’s Sarcoma and a partial response in
a neuroendocrine cancer. Taken together, these results are highly
compelling, making ongoing study a priority.”
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.
ZIOPHARM
Presents Promising Early Data from
Phase Ib Study of Indibulin at 6th International Symposium on Targeted
Anticancer Therapies
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