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): September 25, 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
September 25, 2007, ZIOPHARM Oncology, Inc. issued the press releases attached
hereto as Exhibit 99.1 and Exhibit 99.2, which are incorporated herein by
reference.
Item
9.01 Financial Statements and Exhibits.
(d) Exhibits.
| 99.1 |
Press
Release dated September 25, 2007.
|
| 99.2 | Press Release dated September 25, 2007. |
2
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: September 26, 2007 | By: | /s/ Richard E. Bagley |
|
Richard E. Bagley, |
||
|
President,
Chief Operating Officer
and
Chief Financial
Officer
|
||
3
Exhibit
Index
|
Exhibit
No.
|
Description
|
|
99.1
|
Press
Release dated September 25, 2007.
|
|
99.2
|
Press
Release dated September 25, 2007.
|
4
Exhibit
99.1
Data
From Ongoing Hematological Trials With Darinaparsin
Presented
at European College of Clinical Oncology Annual Meeting
BARCELONA,
Spain, Sep 25, 2007 (BUSINESS WIRE) -- ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP),
announced today the presentation of data from ongoing clinical trials of
darinaparsin (ZIO-101) to treat advanced hematological malignancies. The
data
were presented yesterday at the 14th Annual European Cancer Conference (ECCO)
meeting being held in Barcelona, Spain. The ongoing studies, primarily in
patients with advanced leukemia, are evaluating the safety and activity of
intravenously administered darinaparsin.
Of
14
evaluable patients with advanced disease, 12 had acute myelogenous leukemia
(AML) and two had myelodysplasia (MDS). As a measure of clinical activity,
five
of the 12 AML patients, or 42%, had a decrease in peripheral blood myeloblasts
while both of the MDS patients experienced stable disease. Importantly, therapy
with darinaparsin was well tolerated, particularly with regard to cardiac
toxicity, and adverse events were mild to moderate in severity.
The
Company's Chief Medical Officer, Dr. Brian Schwartz, commented, "The
anti-leukemic activity and safety profile with darinaparsin in these advanced
AML patients is very encouraging. This suggests that both the intravenous
and
oral administration of darinaparsin could be a promising treatment for
hematologic cancers as a single agent or in combination with approved leukemia
therapies. We look forward to completing the ongoing phase II study which
has
recently added sites in the United States and has been extended to India
as well
to include earlier stage patients."
About
Darinaparsin (ZIO-101)
Darinaparsin
is a proprietary small molecule organic arsenic that 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 as well. Intravenously
administered darinaparsin is in multiple phase II trials in advanced myeloma,
other hematological malignancies, and liver cancer. An oral form of darinaparsin
is in phase I study to treat solid tumors.
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
SOURCE:
ZIOPHARM Oncology, Inc.
ZIOPHARM
Oncology, Inc.
Suzanne
McKenna, 646-214-0703
Investors
smckenna@ziopharm.com
or
Tina
Posterli, 917-322-2565
Media
tposterli@rxir.com
#
#
#
Exhibit
99.2
Positive
ZIO-201 Interim Phase II Sarcoma Data Presented at European College of
Clinical
Oncology Annual (ECCO) Meeting
BARCELONA,
Spain (September 25, 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
refractory sarcoma patients were presented by Rashmi Chugh, MD, Principal
Investigator from the University of Michigan at the 14th
Annual
European Cancer Conference (ECCO) meeting being held in Barcelona, Spain.
The
trial has now enrolled 51 patients with soft tissue sarcoma or osteosarcoma
and
the reported interim dataset included the first 31 evaluable patients.
These
patients were refractory to treatment, having undergone a median of four
prior
regimens. Key findings for these 31 evaluable patients at the time of analysis
include:
| · |
In
14 of the 31 patients (45%), there is a clinically beneficial response
including one partial response (PR), four minor responses (MR),
and nine
with stable disease (SD).
|
| · |
In
patients with leiomyosarcoma, five of seven patients (71%), have
stable
disease or better; refractory leiomyosarcoma is very difficult
to treat
with any available therapies.
|
| · |
Of
the 31 patients, 80% had previously been treated with ifosfamide
(IFOS)
while 20% were IFOS naïve; of the IFOS naïve, six of seven (86%) have
stable disease or better.
|
| · |
ZIO-201
is well tolerated with adverse events primarily mild to moderate
and
gastrointestinal or renal related, while no significant bone marrow
suppression, alopecia (hair loss), or neurotoxicity were reported.
|
Sarcoma
is a less well known and understood form of cancer with very few treatment
alternatives following surgery. There is no Food and Drug Administration
(FDA)
approved agent to treat advanced/unresectable sarcoma.
Principal
investigator, Rashmi Chugh, M.D, stated, “These
positive interim results are encouraging with ZIO-201 clearly demonstrating
clinical activity without the bone marrow suppression and neurotoxicities
associated with IFOS treatment. These findings also suggest that ZIO-201
is a
promising candidate to combine with other treatments to enhance activity
without
overlapping toxicities.”
Robert
G.
Maki, MD, PhD., co-leader of the Adult Sarcoma Disease Management Team
at
Memorial Sloan Kettering Cancer Center and not directly participating in
this
study, commented, “These interim data from a difficult-to-treat population
demonstrate ZIO-201 to be a very promising drug candidate. We look forward
to
the maturation of data for the phase II trial with the expectation of an
ensuing
pivotal trial, as ZIO-201 could be of significant clinical benefit in the
treatment of this disease.”
Positive
ZIO-201 Interim Phase II Sarcoma Data Presented at European College
of Clinical
Oncology Annual (ECCO) Meeting
The
Company expects to report final data at upcoming medical meetings, including
the
Connective Tissue Oncology Society Annual Meeting in November 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 ifosfamide (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
II
trial in advanced sarcoma. Trials in ovarian 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