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 23,
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 23, 2010, the Company issued a press release announcing that the
United States Food & Drug Administration (FDA) has granted Orphan Drug
Designation to darinaparsin (Zinapar™ or ZIO-101) for the treatment of
peripheral T-cell Lymphoma (PTCL). 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 23, 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 23, 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 23, 2010
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Exhibit
99.1
ZIOPHARM
Receives FDA Orphan Drug Designation for Darinaparsin in the Treatment of
Peripheral T-cell Lymphoma
NEW YORK, NY (September 23, 2010)
– ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that the United
States Food & Drug Administration (FDA) has granted Orphan Drug Designation
to darinaparsin (Zinapar™ or ZIO-101) for the treatment of peripheral T-cell
Lymphoma (PTCL). The United States Orphan Drug Act of 1983 was created to
provide incentives for companies to develop and market treatments for diseases
or conditions affecting fewer than 200,000 people in the United States. The
Orphan Drug designation provides eligibility for a seven-year period of market
exclusivity in the United States after product approval, an accelerated review
process, accelerated approval where appropriate, grant funding, tax benefits and
an exemption from user fees.
"Peripheral
T-cell lymphomas represent a distinct subgroup of aggressive lymphomas that have
been ignored in most lymphoma studies, creating a population whose treatment
needs remain largely unaddressed in the front line setting,” said James
Armitage, MD, Professor of Internal Medicine, Division of Hematology and
Oncology, University of Nebraska Medical Center. "Darinaparsin has demonstrated
early signs of activity and tolerability in this population, with a mechanism of
action that differentiates it from other existing therapeutic
options.”
ZIOPHARM
reported favorable results from a Phase II trial with IV-administered
darinaparsin in lymphoma, particularly PTCL, at the 2009 Annual Meeting of the
American Society of Clinical Oncology. 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 PTLC, to confirm the tolerability of the
combination. On the advice of leading hematology experts and subject
to the outcome of this Phase I study and further dialogue with the U.S. Food and
Drug Administration, 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. There are currently no FDA-approved therapies for the
front-line treatment of advanced PTCL, a setting where the National
Comprehensive Cancer Network (NCCN) guidelines recommend the use of experimental
drugs.
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 Unites
States. PTCL generally affects people over 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
(Zymafos™ 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. ZIOPHARM is
currently enrolling patients in a randomized, double-blinded, placebo-controlled
Phase III trial of intravenous palifosfamide used in the treatment of metastatic
soft tissue sarcoma in the front-line setting.
Darinaparsin
(ZinaparTM or
ZIO-101) is a novel mitochondrial-targeted agent (organic arsenic) being
developed for the treatment of various hematologic and solid
cancers.
Indibulin
(Zybulin™ 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, 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