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 20, 2011
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
January 20, 2011, ZIOPHARM Oncology, Inc. (the “Company”) issued a press release
announcing that The Committee for Orphan Medicinal Products within the European
Medicines Agency adopted a positive opinion for the designation of darinaparsin'
(Zinapar™ or ZIO-101) as an orphan medicinal product for the treatment of
peripheral T-cell lymphoma. 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 January 20, 2011
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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:
January 26, 2011
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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 January 20, 2011
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Exhibit
99.1
ZIOPHARM
Receives Positive Opinion for Orphan Drug Designation for Darinaparsin from
European Medicines Agency
NEW YORK, NY (January 20,
2011) – ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), announced today that The
Committee for Orphan Medicinal Products (COMP) within the European Medicines
Agency (EMA) adopted a positive opinion for darinaparsin (Zinapar™ or ZIO-101)
designation as an orphan medicinal product for the treatment of
peripheral T-cell lymphoma (PTCL). A positive opinion by the COMP immediately
precedes official designation of darinaparsin as an orphan drug by the European
Commission (EC). Intravenous darinaparsin has demonstrated evidence of activity
in lymphoma, in particular PTCL. ZIOPHARM expects to initiate a
registration-directed study of darinaparsin in patients with PTCL by the end of
2011.
“Orphan
designation recognizes the acute need for new therapies for unmet medical needs,
in this case addressing PTCL, an aggressive form of lymphoma for which there
remains such a need,” said Jonathan Lewis, M.D., Ph.D., Chief Executive Officer
and Chief Medical Officer of ZIOPHARM.
Orphan
Drug Designation by the EC provides regulatory and financial incentives for
companies to develop and market therapies that treat a life-threatening or
chronically debilitating condition affecting no more than five in 10,000 persons
in the European Union (EU). In addition to a 10-year period of marketing
exclusivity in the EU after product approval, Orphan Drug Designation provides
companies with scientific advice and regulatory assistance from the EMA during
the product development phase, direct access to centralized marketing
authorization, as well as reductions in certain fees associated with the
application and approval process.
In
September, ZIOPHARM announced that darinaparsin was granted Orphan Drug
Designation by the U.S. Food and Drug Administration (FDA) for the treatment of
PTCL.
About
PTCL
Peripheral
T-cell Lymphoma represents a subgroup of aggressive lymphomas that develop from
T-cells in different stages of maturity. According to the Lymphoma Research
Foundation, PTCL accounts for approximately 10-15% of the estimated 66,000 new
cases of non-Hodgkin’s lymphoma diagnosed each year in the United States (53,000
in the EU, according to the European Cancer Observatory). PTCL generally affects
people of the age of 60 and is diagnosed in more men than women.
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 is also currently conducting a Phase I
intravenous study of palifosfamide in combination with standard of care
addressing small cell lung cancer and expects to initiate an additional study
with drug in the oral form treating solid tumors.
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. 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 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
is also pursuing the development of novel DNA-based therapeutics in the field of
cancer pursuant to a partnering arrangement with Intrexon Corporation. The
partnership includes two existing clinical-stage product candidates, the first
of which is in a Phase Ib study and the second of which is the basis of an
Investigational New Drug application that ZIOPHARM expects to submit during the
first half of 2011.
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 ZIOPHARM Oncology’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 ZIOPHARM Oncology’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 ZIOPHARM Oncology’s product candidates, the risk that the results of
clinical trials may not support ZIOPHARM Oncology’s claims, the risk that
pre-clinical or clinical trials will proceed on schedules that are consistent
with ZIOPHARM Oncology’s current expectations or at all, risks related to
ZIOPHARM Oncology’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 ZIOPHARM Oncology’s
ability to obtain additional financing to support its operations thereafter, as
well as other risks regarding ZIOPHARM Oncology’s that are discussed under the
heading "Risk Factors" in ZIOPHARM Oncology’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. ZIOPHARM Oncology assumes no
obligation to update these forward-looking statements, except as required by
law.
Contacts:
For
ZIOPHARM:
Tyler
Cook
ZIOPHARM
Oncology, Inc.
617-259-1982
tcook@ziopharm.com
Media:
David
Pitts
Argot
Partners
212-600-1902
david@argotpartners.com