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): December 29, 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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¨
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Written
communications pursuant to Rule 425 under the Securities Act
(17 CFR 230.425).
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¨
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12).
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¨
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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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¨
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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
December 29, 2010, the Company issued a press release announcing that the first
patient has been dosed in a Phase I, single arm, dose escalation study at the
Indiana University Cancer Center of intravenous (IV) palifosfamide (ZIO-201) in
combination with etoposide (VP-16) and cisplatin/carboplatin (platinum) in the
treatment of small cell lung cancer (SCLC) and other cancers. 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.
Item
9.01 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 December 29, 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:
January 5, 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 December 29,
2010
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Exhibit
99.1
ZIOPHARM
Oncology Announces First Patient Dosed in Phase I Study of
Palifosfamide
in Small Cell Lung and Other Cancers
NEW YORK, NY (December 29, 2010) –
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), announced today that the first
patient has been dosed in a Phase I, single arm, dose escalation study at the
Indiana University Cancer Center of intravenous (IV) palifosfamide (ZIO-201) in
combination with etoposide (VP-16) and cisplatin/carboplatin (platinum) in the
treatment of small cell lung cancer (SCLC) and other cancers.
The Phase
I study is expected to enroll 12 to 15 patients and will assess the safety of
the palifosfamide/etoposide/platinum regimen for the planned randomized Phase II
study in SCLC patients with extensive disease where the etoposide/platinum
combination is standard of care.
Palifosfamide
is a novel, bi-functional DNA alkylator and cross-linker, currently in a Phase
III trial for soft tissue sarcoma, and comprises the functional active
metabolite of ifosfamide (IFOS). IFOS is a pro-drug and must be metabolized in
order to be active. The clinical utility of IFOS is often limited by toxicities
associated with IFOS metabolites unrelated to DNA-alkylation and
by development of resistance conferred by decreased pro-drug activation. IFOS
was formally studied in SCLC by the Indiana group where it was added to
etoposide and platinum with evidence of significantly enhanced efficacy as
measured by the endpoints of progression free survival and survival but with the
added toxicity of IFOS negating benefit (Journal of Clinical Oncology, Vol 13,
2594-2599).
“The
efficacy data and low toxicities observed with palifosfamide in clinical and
preclinical studies together with the known activity of ifosfamide in SCLC
provide strong rationale for studying palifosfamide in combination with the
standard of care for this extraordinarily difficult to treat cancer,” said
Lawrence Einhorn, MD, Distinguished Professor at the Simon Cancer Center of
Indiana University Medical Center, Lance Armstrong Foundation Chair in Oncology,
former President of ASCO and a member of ZIOPHARM's Medical Advisory
Board. “Small cell lung cancer in particular is a disease in urgent need
of more effective and better tolerated treatment options.”
According
to the American Cancer society approximately 15 percent of lung cancers are
SCLC, or approximately 33,400 patients yearly in the U.S. SCLC is
almost exclusively associated with cigarette smoking and the majority of
patients with extensive disease are treated front-line but relapse with a very
high mortality within one year.
For more
details about this trial, please see www.clinicaltrials.gov.
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'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