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 27,
2010
ZIOPHARM
Oncology, Inc.
(Exact
Name of Registrant as Specified in Charter)
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Delaware
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001-33038
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84-1475642
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(State
or Other Jurisdiction
of
Incorporation)
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(Commission
File Number)
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(IRS
Employer
Identification
No.)
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1180
Avenue of the Americas
19th
Floor
New
York, NY
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10036
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(Address
of Principal Executive Offices)
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(Zip
Code)
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(646) 214-0700
(Registrant’s
telephone number, including area code)
Not
applicable
(Former
Name or Former Address, if Changed Since Last Report)
Check the
appropriate box below if the Form 8-K is intended to simultaneously satisfy
the filing obligation of the registrant under any of the following
provisions:
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o
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Written
communications pursuant to Rule 425 under the Securities Act
(17 CFR 230.425).
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o
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12).
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o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR 240.14d-2(b)).
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o
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act
(17 CFR 240.13e-4(c)).
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Item
8.01 Other Events.
On
September 27, 2010, the Company issued a press release announcing that the
Japanese Patent Office has issued a patent, Patent No. 4,571,408, with claims
covering pharmaceutical compositions, including oral formulations, of various
organic arsenic compounds, including darinaparsin (ZinaparTM or
ZIO-101), and the use of these compositions and the organic arsenic compounds
for the treatment of cancer, including as part of a combination therapy. A
copy of the above referenced press release is filed as Exhibit 99.1 to this
Current Report on Form 8-K and incorporated herein by reference.
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Item
9.01
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Financial
Statements and Exhibits.
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(d)
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Exhibits
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Exhibit No.
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Description
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99.1
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Press
Release dated September 27, 2010
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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.
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ZIOPHARM
Oncology, Inc.
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By:
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/s/
Richard Bagley
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Date:
September 27, 2010
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Name:
Richard Bagley
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Title:
President, Chief Operating Officer and Chief
Financial
Officer
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INDEX OF
EXHIBITS
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Exhibit No.
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Description
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99.1
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Press
Release dated September 27, 2010
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Exhibit
99.1
ZIOPHARM
Granted Japanese Patent for Darinaparsin
New York, NY – September 27, 2010 – ZIOPHARM Oncology, Inc.
(Nasdaq: ZIOP) today announced that the Japanese Patent Office has issued a
patent, Patent No. 4,571,408, with claims covering pharmaceutical compositions,
including oral formulations, of various organic arsenic compounds, including
darinaparsin (ZinaparTM or
ZIO-101), and the use of these compositions and the organic arsenic compounds
for the treatment of cancer, including as part of a combination
therapy.
ZIOPHARM
recently announced that it has received Orphan Drug Designation from the U.S.
Food and Drug Administration (FDA) for darinaparsin in the treatment of
peripheral T-cell Lymphoma (PTCL). Darinaparsin demonstrated favorable results
in a Phase II trial in lymphoma, particularly PTCL. The Company expects to begin
enrolling patients imminently in a Phase I study of darinaparsin in combination
with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone), the
current standard of care for front-line PTCL, to confirm the tolerability of the
combination. Subject to the outcome of this study and further dialogue with the
FDA, the Company expects to move forward with a registration study of the
darinaparsin and CHOP combination for the front-line treatment of PTCL in late
2011. ZIOPHARM has also recently reinitiated a Phase I study of oral
darinaparsin in advanced solid tumors.
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 DNA cross-linker in class with bendamustine, ifosfamide, and
cyclophosphamide. ZIOPHARM is currently enrolling patients in a
randomized, double-blinded, placebo-controlled Phase III trial with
palifosfamide administered intravenously for the treatment of metastatic soft
tissue sarcoma in the front-line setting. The Company expects to initiate
additional studies in the near-term, including a Phase I IV study of
palifosfamide in combination with standard of care addressing small cell lung
cancer and a Phase I study of oral palifosfamide.
Darinaparsin
(ZinaparTM or
ZIO-101) is a novel mitochondrial-targeted agent (organic arsenic) being
developed intravenously for the treatment of peripheral T-cell lymphoma with a
pivotal study expected to begin in late 2011, following the outcome of a
supporting trial. An oral form is in a Phase I trial in solid
tumors.
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. It is currently being studied in Phase I/II in
metastatic breast cancer.
ZIOPHARM's
operations are located in Boston, MA with an executive office in New York City.
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, the risk that pre-clinical
or clinical trials will proceed on schedules that are consistent with the
Company's current expectations or at all, risks related to the Company's ability
to protect its intellectual property and its reliance on third parties to
develop its product candidates, risks related to the sufficiency of existing
capital reserves to fund continued operations for a particular amount of time
and uncertainties regarding the Company's ability to obtain additional financing
to support its operations thereafter, as well as other risks regarding the
Company that are discussed under the heading "Risk Factors" in the Company's
filings with the United States Securities and Exchange Commission.
Forward-looking statements can be identified by the use of words such as "may,"
"will," "intend," " should," "could," "can," "would," "expect," "believe,"
"estimate," " predict," "potential," "plan," "is designed to," "target" and
similar expressions. 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
Media:
David
Pitts
Argot
Partners
212-600-1902
david@argotpartners.com