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): April 16, 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
April
16, 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 April 16, 2008.
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: April 16, 2008 | By: | /s/ Richard E. Bagley |
|
Richard E. Bagley |
||
| Title: President, Chief Operating Officer and Chief Financial Officer | ||
Exhibit
Index
|
Exhibit
No.
|
Description
|
|
99.1
|
Press
Release dated April 16, 2008.
|
Exhibit
99.1
ZIOPHARM
Presents Positive Data from Phase II Study of Darinaparsin in Advanced
Hematological Malignancies at AACR 2008 Annual Meeting
San
Diego, CA, April 16, 2008 -
ZIOPHARM Oncology, Inc. (NASDAQ:ZIOP) announced today that it presented positive
data from a phase II study of darinaparsin, the Company’s novel organic arsenic
compound, in advanced hematological malignancies at the American Association
for
Cancer Research (AACR) Annual Meeting, April 12-16, 2008 in San Diego,
CA.
A
total
of 40 patients with a variety of hematological malignancies, including leukemias
and lymphomas, have been enrolled in the study, with 40 patients evaluable
for
safety and 21 evaluable for efficacy. In 3 of 7 lymphoma patients evaluable
for
efficacy, 1 patient (peripheral T-cell lymphoma) achieved a complete response,
one patient (nodular sclerosis) is ongoing in cycle 3 with a PET scan interval
response, and one patient (B-cell lymphoma) is ongoing with stable disease
after
5 cycles of therapy. Of 14 leukemia patients evaluable for efficacy, 6 patients
achieved stable disease (3 MDS and 3 CML) and 1 patient withdrew consent prior
to efficacy evaluation. The study is ongoing and patient accrual continues.
In
these patients, therapy with darinaparsin was well tolerated with the most
common serious adverse events being constitutional (pyrexia), pulmonary
(dyspnea), cardiovascular (hypotension), and infection (sepsis)
related.
“Administration
of darinaparsin to patients diagnosed with advanced hematological malignancies
has been well-tolerated, and tumor response, including a complete response
in a
highly refractory T-cell lymphoma patient, is very encouraging,” commented
Michael Craig, M.D., Assistant Professor and Interim Director of Blood and
Marrow Transplantation of West Virginia University and a lead investigator
of
the study. “Because cure rates are low in advanced disease but progression can
be slow, achieving stable disease or better could have a meaningful impact
on
patient outcome. Further study of darinaparsin in hematological malignancies,
particularly in lymphomas, is highly warranted.”
For
more
details on these trials please see www.clinicaltrials.gov.
About
Darinaparsin
Darinaparsin
is a proprietary small molecule organic arsenic licensed 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 pathway
leading to apoptosis. In addition, darinaparsin interrupts the cell cycle at
the
G2/M phase of tumor cells inducing cell death through this pathway.
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