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): November 9, 2006
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
November 9, 2006 and November 10, 2006, the Company issued the press releases
attached hereto as Exhibits 99.1 and 99.2, which are incorporated herein by
reference.
Item
9.01 Financial Statements and Exhibits.
(d) Exhibits.
99.1 Press
Release dated November 9, 2006.
99.2 Press
Release dated November 10, 2006.
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: November 10, 2006 | 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 November 9, 2006
|
|
|
99.2
|
Press
Release dated November 10, 2006
|
Exhibit
99.1
ZIOPHARM
Announces New ZIO-101 Mechanism Data at EORTC-NCI-AACR
--Further
Differentiates ZIO-101--
PRAGUE
-
November 9, 2006 - ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP) announced the
presentation today by Dr. Taghi Manshouri of the University of Texas M. D.
Anderson Cancer Center of new mechanism data that further differentiates
ZIO-101, a novel organic arsenic, from inorganic arsenic. The mechanism data
indicate that certain cancer cells resistant to inorganic arsenic are sensitive
to ZIO-101. The presentation was part of the 18th EORTC-NCI-AACR Symposium
on
“Molecular Targets, and Cancer Therapeutics” meeting held in Prague. ZIO-101
clinical data will be the subject of a separate presentation at this meeting
on
November 10th.
Dr.
Manshouri’s data show that the major intra-cellular target of arsenic is the
mitochondria, an organelle responsible for the energy charge of the cell.
Disruption of mitochondrial function leads to apoptosis and cell death. Based
on
this mechanism ZIO-101 induces more cancer cell killing than inorganic arsenic.
In addition, preliminary data from this study suggest that different genes
are
regulated by ZIO-101 than inorganic arsenic.
ZIO-101
has now entered phase II study in advanced multiple myeloma. The Company
anticipates initiating phase II trials in other hematological malignancies
and
solid tumors early in 2007 and is planning on filing an Investigational New
Drug
application with the U.S. Food and Drug Administration for oral administration
of ZIO-101 in the first half of 2007.
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
Tina
Posterli
Media
(917)
322-2565
tposterli@rxir.com
Exhibit
99.2
ZIOPHARM
Announces Positive ZIO-101 Clinical Data at EORTC-NCI-AACR
--Phase
II Trials Underway--
PRAGUE
-
November 10, 2006 - ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP) announced today
the
presentation by Luis Camacho, MD of the University of Texas M. D. Anderson
Cancer Center of positive phase I clinical data for ZIO-101, an organic arsenic,
from trials in both hematological cancers and solid tumors. Clinical activity
was seen over a range of doses and ZIO-101 has now entered phase II trials.
The
poster was part of the 18th EORTC-NCI-AACR Symposium on “Molecular Targets, and
Cancer Therapeutics” held in Prague.
Of
the
total 53 patients treated, 29 had diverse advanced solid tumors and 24 had
blood
and bone marrow cancers. There was clinical activity in 13 of 43 (30%) evaluable
patients reported today. Clinical and pharmacokinetic data show that ZIO-101
is
safe at doses up to 420mg/m2/d
for
five consecutive days every four weeks. The major dose limiting toxicity was
transient and reversible confusion/ataxia. ZIO-101 did not evidence QT
prolongation and other toxicities seen with inorganic arsenic
(Trisenox®).
Phase
II
trials have started in multiple myeloma. Phase II trials in other hematologic
cancers and in liver cancer are expected to initiate early in 2007. The filing
of an Investigational New Drug application with the U. S. Food and Drug
Administration for an oral form of ZIO-101 is anticipated in the first half
of
2007 with a phase I clinical trial expected to initiate soon
thereafter.
“We
see a
strong signal of clinical activity in these early phase I studies,” commented
Dr. Brian Schwartz, Chief Medical Officer at ZIOPHARM. “The fact that this
activity is evident over a range of doses in a variety of cancers, coupled
with
the growing body of pharmacokinetic data provides us with ample ammunition
to
explore this drug in phase II trials.”
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
Investor Relations
Investors
(646)
214-0703
smckenna@ziopharm.com
Tina
Posterli
Rx
Communications
Media
(917)
322-2565
tposterli@rxir.com