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): October 14, 2009
ZIOPHARM
Oncology, Inc.
(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:
o Written communications
pursuant to Rule 425 under the Securities Act
(17 CFR 230.425).
o Soliciting material
pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12).
o Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act
(17 CFR 240.14d-2(b)).
o 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
October 14, 2009, the Company issued a press release announcing interim analysis
data from its randomized phase II trial of palifosfamide (ZymafosTM,
ZIO-201) in treating patients with unresectable or metastatic soft tissue
sarcoma.
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 October 14,
2009
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2
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:
October 14, 2009
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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 October 14,
2009
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4
Exhibit
99.1
ZIOPHARM
Announces Positive Palifosfamide Sarcoma
Randomized
Phase II Interim Data: Trial Enrollment Stopped Early
--Full
Interim Data Presentation at CTOS--
NEW YORK, NY – October 14,
2009 - ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today positive
top line interim data from the multicenter randomized Phase II trial of
palifosfamide (ZymafosTM,
ZIO-201) treating patients with unresectable or metastatic soft tissue sarcoma.
The analysis evaluated 62 patients treated as of the end of September, with 58
being analyzed. As a result of reaching a key efficacy milestone and following
safety and efficacy data review by the Data Committee, sarcoma experts, and the
Company’s Medical Advisory Board, the decision was reached formally to stop
enrollment yesterday in the trial. The Company will report the interim data in
full at the upcoming Connective Tissue Oncology Society (CTOS) Annual Meeting on
November 5th and
plans to initiate a registration trial following regulatory review of the
palifosfamide program to date.
The
Randomized Phase II trial treats patients with unresectable or metastatic soft
tissue sarcoma in the front- and second-line setting. Patients are randomized
either to doxorubicin (the current only FDA approved agent in sarcoma) or to
palifosfamide in combination with doxorubicin. A total of 58 patients have been
evaluated for PFS (progression-free survival) with 19 documented PFS events
(doxorubicin alone = 13 events; palifosfamide + doxorubicin = 6 events) based on
a three month median follow-up time. With this analysis based on all randomized
and eligible patients, the hazard ratio is 0.67 favoring palifosfamide +
doxorubicin (two-sided Wilcoxon-Gehan p-value = 0.042); the pre-defined
milestone was to reach one-sided p=0.1.
The
interim safety data indicate that the addition of palifosfamide does not add to
the toxicity of single agent doxorubicin. The most frequently reported side
effects in both arms of the study include neutropenia and fatigue, hypokalemia,
nausea, anemia, leucopenia, and alopecia. Palifosfamide is usually easily
administered as an out-patient treatment, and generally
well-tolerated.
“The hypothesis of the randomized Phase
II trial design for this very difficult to treat cancer population has been
validated and the interim results are promising and supportive of a pivotal
trial,” said Robert Maki, MD, PhD, co-leader of the adult sarcoma program at
Memorial Sloan-Kettering Cancer Center, and current President of CTOS
(Connective Tissue Oncology Society), a multidisciplinary sarcoma specialty
group.
“This
will hopefully continue to progress forward step by step and result in a new
treatment option for patients with a high unmet need” said Murray Brennan, MD,
Chairman Emeritus of Surgery at Memorial Sloan-Kettering Cancer Center, renowned
sarcoma expert and Lead Director at ZIOPHARM.
More
detailed data will be reported at CTOS. Subsequently, the Company will be
formalizing a final registration trial plan for review by the appropriate
regulatory authorities.
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 is 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 alkylating drugs used to treat certain cancers. Palifosfamide does not have
the toxic metabolites of ifosfamide that cause the debilitating side effects of
“fuzzy brain” (encephalopathy) and severe bladder inflammation. Intravenous
palifosfamide is currently in a randomized Phase II trial, the subject of this
press release, to treat unresectable or metastatic soft tissue sarcoma in the
front- and second-line setting, a study expected to establish the basis for a
registration trial as early as the first half of 2010. An oral form of
palifosfamide has been developed preclinically to the investigational new drug
application stage.
Darinaparsin
(ZinaparTM or
ZIO-101) is a novel
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. Phase I and Phase II testing of the intravenous
form of darinaparsin in solid tumors and hematological cancers has been
completed or is nearing completion. The Company has reported clinical activity
and, importantly, a safety profile from these studies as predicted by
preclinical results. Favorable results from the trial with IV-administered
darinaparsin in lymphoma, particularly peripheral T-cell lymphoma (“PTCL”), were
reported at the American Society of Clinical Oncology (‘ASCO”) in May. Supported
by these data, the Company expects to advance into a registration trial in
peripheral T-cell lymphoma as early as the first half of 2010. Also as reported
at ASCO, in ongoing Phase I trials the oral form is active and well
tolerated.
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.
In multiple Phase I trials in cancer patients, oral indibulin has been
administered both as a single agent and in combination with favorable activity
and a promising safety profile that does not include the neurotoxicity seen with
all of the other classes of tubulin binding agents. Most recently, results of
oral indibulin in combination with oral capecitabine (Xeloda®) were
presented at this year’s American Society of Clinical Oncology (ASCO) along with
the preclinical findings of a novel dosing schedule conducted under the
direction of Dr. Larry Norton. The Company expects to initiate a Phase I/II
study of oral indibulin in breast cancer patients employing this dosing schedule
established preclinically. Once the maximum tolerated dose is established in the
Phase I portion of the trial, Phase II will proceed with an expanded
population.
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 final trial data may
not support interim analysis and that the results of clinical trials in general
may not support the Company's claims, risks related to the Company's ability to
protect its intellectual property, risks related to 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.
# # #
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