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): January 26, 2010
(Exact
Name of Registrant as Specified in Charter)
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Delaware
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0-32353
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84-1475672
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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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Written
communications pursuant to Rule 425 under the Securities Act
(17 CFR 230.425).
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12).
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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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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
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Other
Events
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On
January 26, 2010, the Company issued a press release announcing that
it has received a Notice of Allowance from the U.S. Patent and Trademark Office
for claims related to the Company’s proprietary palifosfamide
composition (ZIO-201 or ZymafosTM).
A copy of
the above referenced press release is filed as Exhibit 99.1 to this
Current Report of Form 8-K.
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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 of the Company dated January 26,
2010
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2
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:
January 26, 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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3
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 of the Company dated January 26,
2010
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4
Exhibit
99.1
ZIOPHARM
RECEIVES IMPORTANT PALIFOSFAMIDE U.S. PATENT ALLOWANCE
--
Additional Patent Issuances for Darinaparsin and Indibulin --
New York, NY – January 26,
2010 - ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that it has
received a Notice of Allowance from the U.S. Patent and Trademark Office
for Application Serial No. 11/257,766 entitled “Salts of
Isophosphoramide mustard and analogs thereof as anti-tumor agents” with claims
directed to compounds, pharmaceutical compositions, and lyophilisates. These
claims cover the Company’s proprietary palifosfamide composition (ZIO-201 or
ZymafosTM). The
Company has recently reported positive randomized Phase II sarcoma interim data
for intravenous palifosfamide at the Annual Meeting of the Connective Tissue
Oncology Society (CTOS) on November 6, 2009 and expects, following U.S. Food and
Drug Administration (FDA) review, to initiate a registration trial the first
half of 2010.
ZIOPHARM
has also recently been granted United States Patent No. 7,619,000 covering the
oral administration of various organic arsenic compounds, including
darinaparsin, for the treatment of cancer. Darinaparsin (ZIO-101 or ZinaparTM) is a novel
mitochondrial-targeted agent having been studied intravenously in Phase II for
the treatment of lymphoma while the oral form continues in Phase I study for
both hematological malignancies and solid tumors. The Company also expects to
initiate a registration trial for darinaparsin in peripheral T-cell lymphoma
following FDA review.
Additionally,
ZIOPHARM has been granted Patent No. 2,326,833 by the Canadian Intellectual
Property office covering certain N-substituted indole-3-glyoxylamides, including
indibulin, for use as an antitumor agent. Indibulin (ZIO-301 or ZybulinTM) is the
Company’s novel oral microtubule inhibitor being developed for the treatment of
breast cancer sub-types and is expected to enter Phase I study in the first
quarter of this year in collaboration with the Memorial
Sloan-Kettering team and using a novel biologically- and mathematically-driven
schedule of administration developed preclinically by Dr. Larry
Norton.
“With
this notice of allowance for palifosfamide, we now have established a U.S.
patent position for all three of our product candidates,” said Jonathan Lewis,
MD, PhD, Chief Executive Officer of ZIOPHARM. “With the additional
issuances for darinaparsin and indidibulin, we continue to add to our patent
estates, and will continue doing so for all three programs.”
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) references a novel composition (tris formulation) that comprises the
functional active metabolite of ifosfamide, a standard of care for treating
sarcoma, lymphoma, testicular, and other cancers. Palifosfamide delivers
only the cancer fighting component of ifosfamide. It is expected to overcome the
resistance seen with ifosfamide and cyclophosphamide, two of the most commonly
used DNA-alkylating drugs used to treat cancers.
Darinaparsin
(ZinaparTM or
ZIO-101) is a novel
anti-mitochondrial (organic arsenic) being developed for the treatment of
various hematologic and solid cancers. Preclinical and clinical studies to date
have demonstrated that darinaparsin is considerably less toxic than inorganic
arsenic, particularly with regard to cardiac toxicity.
Indibulin
(ZybulinTM or
ZIO-301) is a
novel, oral tubulin binding agent that targets both mitosis and cancer cell
migration. In addition, indibulin is expected to have several potential
benefits, including oral dosing, application in multi-drug resistant tumors, no
neuropathy and minimal overall toxicity.
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, 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. The Company assumes no
obligation to update these forward-looking statements, except as required by
law.
# # #
Contacts:
Susan
Noonan
S.A.
Noonan Communications, LLC
(212)
966-3650
susan@sanoonan.com
Eric
Goldman - Media
Rx
Communications Group
917-322-2563
egoldman@rxir.com
Tyler
Cook
ZIOPHARM
Oncology, Inc.
617-259-1982
tcook@ziopharm.com