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 9, 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
July
9, 2007, the Company issued a press release and such press release is attached
hereto as Exhibits 99.1 and is incorporated herein by reference.
Item
9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1 Press
Release dated July 9, 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.
| Date: July 9, 2007 |
ZIOPHARM
Oncology, Inc.:
(REGISTRANT)
|
|
| |
|
|
| By: | /s/ Richard E. Bagley | |
|
RICHARD E. BAGLEY, President, Chief Operating Officer and Chief Financial Officer |
||
Exhibit
Index
|
Exhibit
No.
|
Description
|
|
|
99.1
|
Press
Release dated July 9, 2007
|
Exhibit
99.1
Positive
ZIO-201 Interim Phase II Sarcoma Data Presented at European Society for Medical
Oncology
Demonstrated
Response and Tolerability in Heavily Pretreated Sarcoma
Patients
LUGANO,
Switzerland (July 9, 2007)
-
ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP) announces that positive interim data
from
an ongoing phase II trial of ZIO-201 (isophosphoramide mustard - IPM) to treat
advanced sarcoma patients was presented at the European Society of Medical
Oncology (ESMO) meeting held July 5-8, 2007 in Lugano, Switzerland. The abstract
entitled, “Phase-I/II
Study of IPM (ZIO-201) In Advanced Sarcoma,”
was
presented by Rashmi Chugh, MD, a Principal Investigator from the University
of
Michigan, Ann Arbor, Michigan.
The
trial
has now enrolled 39 patients and this presentation reports on the first 10
evaluable patients. Of these 10 heavily pretreated patients (median 4 prior
regimens), 1 has a partial response (21 weeks and ongoing) and 4 have stable
disease. Of these 5 patients, 2 had progressed through prior ifosfamide (IFOS)
treatment. ZIO-201 was shown to be well tolerated at the phase II dose with
no
significant bone marrow suppression, alopecia (hair loss) or neurotoxicity
reported. Based on this encouraging data, enrollment has been expanded to
include additional patients.
“Ifosfamide
is one of the few effective standard therapies available for most sarcomas,”
commented Dr. Chugh. “Having a novel drug that could offer the benefits of
high-dose ifosfamide without the debilitating side effects, particularly the
bone marrow suppression and neurotoxicity, would be of great benefit in the
treatment of this disease. We are enthusiastic about these early results and
we
look forward to further elucidating the overall impact of ZIO-201 in this
setting.”
The
Company expects to report more complete data at upcoming medical meetings,
including the 14th European Cancer Conference (ECCO) taking place in Barcelona
from September 23-27, 2007.
About
ZIO-201
ZIO-201,
the active moiety of IFOS, is a bi-functional alkylator that causes irreparable
inter-strand DNA cross-linking resulting in cell death. ZIO-201 is equal to
or
more active than IFOS in diverse cancer models. Unlike IFOS, which is a
pro-drug, ZIO-201 is directly active against cancer cells. Also, unlike IFOS,
ZIO-201 is not metabolized to acrolein or chloroacetaldehyde which cause bladder
or central nervous system toxicities. ZIO-201 continues in a phase I trial
in
diverse cancers exploring maximum tolerated dose at alternate schedules. A
phase
II trial in advanced sarcoma continues to enroll patients. Trials in lymphoma
and pediatric cancers are in the advanced planning stage. An oral form of
ZIO-201 is in advanced preclinical development.
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
Investors
(646)
214-0703
smckenna@ziopharm.com
Tina
Posterli
Media
(917)
322-2565
tposterli@rxir.com