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 17, 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
November 17, 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 November 17, 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.
|
ZIOPHARM
Oncology, Inc.:
(Registrant)
|
||
| |
|
|
| Date: November 17, 2008 | By: | /s/ Richard E. Bagley |
|
Name: Richard E. Bagley |
||
|
Title:
President
and Chief Operating Officer
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||
Exhibit
99.1
ZIOPHARM
ONCOLOGY PRESENTS POSITIVE DATA FROM STUDIES OF PALIFOSFAMIDE
Palifosfamide
active as single agent and in combination
LONDON,
UK - NOVEMBER 17, 2008
-
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that it presented
positive data from a Phase I study of palifosfamide (ZymafosTM)
in
combination with doxorubicin at the 14th
Annual
Connective Tissue Oncology Society (CTOS) meeting held in London, UK, November
13 to 15. Also presented was an update of the data from the Phase II trial
of
palifosfamide used as a single agent in advanced sarcoma.
The
Phase
I trial of palifosfamide in combination with doxorubicin was fully enrolled
with
13 metastatic patients, of whom 8 were still receiving therapy. The combination
was well tolerated with no dose-limiting toxicities reported during a total
of
51 cycles of treatment. Of 12 evaluable patients, 3 had partial responses.
Of
the 8 patients with soft tissue sarcoma (STS), 2 had partial responses and
the
remaining 6 patients were progression free with a median duration of follow-up
of 15 weeks and were still on therapy.
The
update from the Phase II trial investigating palifosfamide as a single agent
against advanced STS revealed 3-month progression free rates of 45% overall
and
55% in ifosfamide-naïve patients. The 6-month progression free rate was 23% at 6
months. These data show that palifosfamide is highly active in STS.
In
both
studies, none of the 19 patients who have been treated with the novel
palifosfamide-T (TRIS/mannitol drug product) experienced renal toxicity nor
bladder toxicity or encephalopathy commonly associated with ifosfamide
treatment.
As
a
result of the data generated in these studies, the Company has initiated a
Phase
II randomized controlled trial comparing palifosfamide plus doxorubicin vs.
doxorubicin in the front- and second-line treatment setting of STS.
“The
study results for palifosfamide are highly encouraging,” commented Sant P.
Chawla, MD, Director, Sarcoma Oncology Center and a lead investigator for the
studies. “The data indicate palifosfamide is active both as a single agent and
in combination and bode very well for the randomized Phase II
trial.”
To
view
the presentation please visit: http://www.ziopharm.com/docs/ZIOPHARM_CTOS_NOV_2008.pdf
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
(ZymafosTM
or
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
(ZybulinTM
or
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
(ZinaparTM
or
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 favorable 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.
Contacts:
Tyler
Cook
ZIOPHARM
Oncology, Inc.
(617)
259-1982
tcook@ziopharm.com
or
Melody
Carey
Rx
Communications Group
(917)
322-2571
mcarey@rxir.com