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): November 6, 2009
(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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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
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Other
Events
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On
November 6, 2009, the Company issued a press release announcing that it
presented positive palifosfamide (ZymafosTM or
ZIO-201) sarcoma randomized Phase II interim data at the annual meeting of the
Connective Tissue Oncology Society (“CTOS”) held in Miami Beach, Florida on
November 6, 2009.
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 November 6,
2009
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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:
November 6, 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 November 6,
2009
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4
Exhibit
99.1
ZIOPHARM
Presents Positive Palifosfamide Sarcoma
Randomized
Phase II Interim Data at Annual Meeting of the
Connective
Tissue Oncology Society
--
Palifosfamide prolongs progression-free survival by at least 50% --
NEW YORK, NY – November 6,
2009 - ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) presented today at the
15th
Annual Connective Tissue Oncology Society (CTOS) Meeting, positive interim data
from the multicenter randomized Phase II trial of palifosfamide (ZymafosTM,
ZIO-201) treating patients with unresectable or metastatic soft tissue sarcoma.
As previously announced, having achieved the study-specified efficacy milestone
following planned safety and efficacy review by the Data Committee, a panel of
international sarcoma experts, and the Company’s Medical Advisory Board, it was
determined that the data are compelling and sufficient to proceed to a pivotal
study in support of product registration and to conclude enrollment in the
trial.
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 only currently FDA-approved agent in sarcoma) or to
palifosfamide in combination with doxorubicin. As of the October 5th cut-off
date, there were 67 patients randomized to the trial, with 65 treated and 61
eligible for analysis. The 61 patients were evaluated for progression-free
survival (PFS) with 20 documented PFS events (doxorubicin alone = 14 events;
palifosfamide + doxorubicin = 6 events). With this analysis of all randomized
and eligible patients, the hazard ratio is 0.63 favoring palifosfamide +
doxorubicin (two-sided Wilcoxon-Gehan p-value = 0.026), statistically supporting
that palifosfamide prolongs PFS by at least 50%.
The
median PFS for doxorubicin is 4.4 months, the median PFS for palifosfamide +
doxorubicin has not yet been reached; the 1st quartile PFS was 1.5 months for
doxorubicin vs. 3.5 months for palifosfamide + doxorubicin (PFS more than
doubled at this level). PFS is a biologically important end point in
sarcoma, and has been well demonstrated to be a relevant measurement of the
effect of treatment on outcome.
The arms
of the trial were very well-balanced by predetermined stratification in terms of
1) Age (≥65 years and < 65 yrs) and 2) Pre-selected histopathological
subtypes (leiomyosarcoma, synovial sarcoma and “other”). In addition, and
consequently, this also resulted in balance between front- and second-line
patients.
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 easily administered
as an out-patient treatment, and generally well-tolerated.
“These
interim results are very promising, indicating a potentially new drug to help
control this life-threatening disease with acceptable safety and quality of
life,” commented George Demetri, MD, Director of the Center for Sarcoma and Bone
Oncology and the Ludwig Center at the Dana-Farber Cancer Institute and Harvard
Medical School, and a member of ZIOPHARM’s Medical Advisory Board, whose
experience includes having served as lead investigator in the clinical trials
leading to the approval of GleevecTM and
Sutent TM to
treat GIST, a form of soft tissue sarcoma.
“These
data are not only encouraging for sarcoma but hopefully palifosfamide may also
work in treating other cancers. This is particularly interesting if
the oral form is successful in the clinic,” added 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 also a member of ZIOPHARM’s Medical Advisory Board, whose experience
includes having served as the principal investigator in the development of
ifosfamide in curing testicular cancer.
The
Company is in the process of finalizing a registration trial plan in soft tissue
sarcoma for review by the appropriate U.S. and international regulatory
authorities.
The
presentation is viewable at:
http://www.ziopharm.com/docs/ZIOPHARM_CTOS_Nov09.pdf
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