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 23, 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:
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 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 October 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.
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ZIOPHARM
Oncology,
Inc.:
(Registrant)
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| Date: October 23, 2008 | By: | /s/ Richard E. Bagley |
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Name: Richard E. Bagley |
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| Title: President and Chief Operating Officer | ||
Exhibit
99.1
ZIOPHARM
Presents Darinaparsin Molecular Mechanism of Action and Preliminary Oral
Administration Phase I Clinical Data at the EORTC-NCI-AACR Symposium
Darinaparsin
has unique molecular mechanism and is active orally
Geneva,
Switzerland - October 23, 2008 - ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP),
announced today that it presented darinaparsin (ZIO-101) mechanism of action
data as well as preliminary data from Phase I studies with oral administration
at the 20th
EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics in
Geneva,
Switzerland.
Data
from
preclinical studies on the molecular mechanism of action of darinaparsin
were
presented demonstrating that darinaparsin is highly active in a series of
cell
lines including those resistant to inorganic arsenic, or arsenic trioxide
(ATO).
In contrast to ATO, darinaparsin is not a substrate for the multi-drug
resistance protein complex MRP1/ABCC1 and is therefore not exported as
efficiently from cells resulting in a greater intracellular accumulation.
This
accumulation correlates with more potent induction of pathways involved in
oxidative stress and programmed cell death in cells treated with darinaparsin
than in those treated with ATO. Comparative data presented on the effect
of
these two compounds on various signal transduction pathways leading to apoptosis
indicate that darinaparsin does trigger apoptosis through pathways that do
not
completely overlap with ATO and explain the more potent cytotoxic activity
of
darinaparsin. Specifically, darinaparsin is JNK dependent, but not MAP3K
dependent. In addition, darinaparsin induces cell death despite overexpression
of MRP1/ABCC1.
In
Phase
I studies, a total of 32 patients with advanced cancers have been treated
with
various orally administered dose and treatment schedules. Safety, activity
and
bioavailability have been evaluated. To date, all patients are evaluable
for
safety and 17 for clinical activity with five patients still being treated.
Of
the 17 patients evaluable for activity, 10 patients (59%) have stable disease
for at least two months of treatment. Oral darinaparsin was well tolerated
with
manageable side effects of nausea and vomiting. Further enrollment and dose
escalation is ongoing. The serum level obtained by oral administration compared
to intravenous administration (IV) showed a very favorable bioavailability
and
very similar pharmacokinetics. The oral studies will be presented when complete
at a scientific meeting in 2009.
“These
preliminary safety, activity and bioavailability results with orally
administered darinaparsin are particularly encouraging in light of the favorable
responses already obtained in a Phase II study of the IV formulation in
lymphomas,” commented Jonathan Lewis, MD, PhD, and Chief Executive and Medical
Officer of ZIOPHARM. “These results strongly support the future study of the
oral formulation. In addition, these preclinical data help elucidate the
mechanism of action of this molecule.”
ZIOPHARM
Presents Darinaparsin Molecular Mechanism of Action and Preliminary Oral
Administration Phase I Clinical Data at the EORTC-NCI-AACR
Symposium
About
ZIOPHARM Oncology, Inc.:
ZIOPHARM
Oncology is
a
biopharmaceutical company engaged in the development and commercialization
of a
diverse portfolio of cancer drugs. The Company is currently focused on three
clinical programs.
Palifosfamide
(ZIO-201) is a novel molecule that is the functional active metabolite of
ifosfamide, a standard of care for treating sarcoma, testicular and other
cancers. Palifosfamide delivers only the cancer fighting component of
ifosfamide. It is expected to overcome the resistance of ifosfamide and
cyclophosphamide in certain cancers. It does not have the toxic metabolites
of
ifosfamide that cause the debilitating side effects of “fuzzy brain”
(encephalopathy) and severe bladder inflammation. Intravenous (IV) palifosfamide
is currently in a Phase II randomized trial to treat soft tissue sarcoma.
An
oral form of palifosfamide has been developed preclinically and is expected
to
enter clinical study in 2009.
Indibulin
(ZIO-301) is
a
novel, oral tubulin binding agent that targets both mitosis and cancer cell
migration. Indibulin is expected to have several potential benefits, including
oral dosing, application in multi-drug resistant tumors, no neuropathy and
minimal overall toxicity.
Indibulin
has shown early activity in Phase I study as a single agent in many types
of
solid tumors. Indibulin is also currently in the Phase I portion of Phase
I/II
trials in combination with Tarceva® and Xeloda®. Preclinical study continues
with both dose density and metronomic administration.
Darinaparsin
(ZIO-101) is
a
novel organic arsenic being developed for the treatment of various hematologic
and solid cancers. Preclinical and Phase I and II results to date demonstrate
that darinaparsin is much less toxic than other forms of arsenic. Intravenous
darinaparsin continues to be studied in a Phase II hematology trial with
favorably treatment activity in certain lymphomas and in Phase I study with
oral
administration. Darinaparsin has been well tolerated in all trials to
date.
ZIOPHARM’s
operations are located in Boston, MA with an executive office in New
York.
Further
information about ZIOPHARM may be found at www.ziopharm.com.
ZIOP-G
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.
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Contacts:
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Tyler
Cook
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Melody
Carey
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ZIOPHARM
Oncology, Inc.
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Rx
Communications Group, LLC
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(617)
259-1982
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(917)
322-2571
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tcook@ziopharm.com
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mcarey@rxir.com
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