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): July 19, 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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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 July
19, 2010, the registrant issued a press release announcing initiation of its
pivotal Phase III clinical trial for palifosfamide (ZymafosTM) in patients with
front-line metastatic soft tissue sarcoma. A copy of the press
release is filed as Exhibit 99.1 to this Current Report on Form
8-K.
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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 July 19, 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:
July 20, 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 July 19, 2010
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Exhibit
99.1
ZIOPHARM
Announces Initiation of Palifosfamide Pivotal Study
--
Front-Line Therapy Trial for Patients with Metastatic Soft Tissue Sarcoma
- --
Company
to Host Conference Call and Webcast with Outside Experts
on
Tuesday, July 20th at 8:00
a.m. EST
NEW YORK, NY (July 19, 2010) –
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) today announced the initiation of the
pivotal Phase III clinical trial for palifosfamide (ZymafosTM) in
patients with front-line metastatic soft tissue sarcoma. The study, called
PICASSO 3, is an international, randomized, double-blinded, placebo-controlled
trial designed to enroll approximately 424 patients with metastatic soft tissue
sarcoma who have never been treated with chemotherapy for metastatic disease.
The study is designed to evaluate the safety and efficacy of palifosfamide
administered with doxorubicin compared with doxorubicin administered with
placebo, with no crossover between arms. Progression-free survival (PFS) is the
primary endpoint for accelerated approval, with overall survival (OS) as the
primary endpoint for full approval. Palifosfamide has Orphan Drug status in both
Europe and the United States.
The
pivotal trial protocol was developed in a process with the U.S. Food and Drug
Administration (FDA) that included discussion at an End of Phase II meeting and
a subsequent dialogue for Special Protocol Assessment (SPA). FDA advised that
PFS could be used as a primary endpoint outside of formal SPA with the study
outcome subject to review. Regulatory acceptability will depend on the magnitude
of the difference between the trial study arms as well as a risk and benefit
analysis. Having reached consensus with FDA, including on the methodology of
radiologic evaluation of PFS, and based upon external expert opinion, the
Company elected to initiate the pivotal Phase III trial without formal SPA and
retaining PFS as a primary endpoint.
The
PICASSO 3 trial has 85% power to detect a 0.60 hazard ratio (HR) advantage for
the palifosfamide combination arm for PFS. Following a pre-determined number of
PFS events and Independent Data Monitoring Committee (IDMC) review and
recommendation, coupled with review of the then available survival data by the
IDMC (to which the Company and Investigators will remain blinded), the Company
could file for accelerated approval based on PFS. The Company and its external
advisors estimate that a median increase in PFS of 3 months or greater over the
control arm (control arm median PFS estimated to be 4.3 months) could achieve a
targeted hazard ratio (HR=0.60; p=0.0005, one-tailed) and also predict a
demonstrable improvement in overall survival. Sarcoma and oncology experts
consulted by the Company believe that this would represent a clinically
meaningful improvement in PFS in this disease setting and that this study design
is a statistically reliable evaluation regarding whether the experimental
intervention is safe and provides clinically meaningful benefit. The PICASSO 3
study is designed as a close follow-on study to the publicly-reported PICASSO
trial, which demonstrated a statistically significant improvement in PFS
(HR=0.39; median PFS improvement of 3.4 months, p=0.023) for the combination
over doxorubicin alone.
PICASSO 3
will be conducted at approximately 150 centers in North America, Europe, South
America, Australia, Israel and Korea.
The
Steering Committee for the pivotal trial includes:
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·
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Prof.
Jean-Yves Blay, President of the EORTC (European Organization for Research
and Treatment of Cancer), Professor of Medicine at the Universite Claude
Bernard and Scientific Director of the Canceropole, Lyon,
France
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·
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Prof.
Xavier Garcia del Muro, President of the Spanish Group for Research in
Sarcoma (GEIS) and Member of Medical Oncology Service of the
Institut Catala d’Oncologia, Barcelona,
Spain
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·
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Dr.
George Demetri, Director of the Center for Sarcoma and Bone Oncology at
Dana Farber Cancer Institute and the Ludwig Center at the
Dana-Farber/Harvard Cancer Center, Boston, USA and a member of the
ZIOPHARM Scientific Advisory Board (non-equity
holding)
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·
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Dr.
Jayesh Desai, member of the Board of Directors of the Australasian Sarcoma
Study Group, the Royal Melbourne Hospital and Peter MacCallum Cancer
Centre in Melbourne, Australia, and Director for Cancer Trials
Australia
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·
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Prof.
Peter Hohenberger, Chairman EORTC Soft Tissue and Bone Sarcoma Group and
Member Division of Surgical Oncology and Thoracic Surgery at Mannheim
University Medical Center, Mannheim,
Germany
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·
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Prof.
Ian Judson, past president of CTOS (Connective Tissue Oncology Society)
and EORTC Sarcoma Group, Co-Team Leader of the Clinical Pharmacology and
Trials Team of the UK Institute of Cancer Research and Head of Sarcoma at
the Royal Marsden, London
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·
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Dr.
Robert Maki, immediate past president of CTOS (Connective Tissue Oncology
Society) and Co-leader of Adult Sarcoma Disease Management Team at
Memorial Sloan-Kettering Cancer Center, New York,
USA
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Dr. Maki
stated: “Metastatic soft-tissue sarcoma is a disease for which we have seen few
advances in treatment and no U.S. regulatory approvals in over two decades.
Palifosfamide has demonstrated promising activity and tolerability in Phase II,
including a clinically meaningful improvement in PFS.”
“PICASSO
3 is powered to show a significant improvement in disease control, as assessed
by PFS,” added Dr. Demetri. “This design allows for the possibility of
accelerated approval using a PFS endpoint, an outcome which leaders in the
sarcoma community believe could provide patients in vital need of more treatment
options with earlier access to a new therapy.”
About
Soft Tissue Sarcoma
Soft
tissue sarcomas are cancers of the body soft tissues, including cartilage,
muscle, fat, nerves, blood vessels and other connective tissue. They may develop
in any part of the body, but are most common in the trunk, arms, and legs.
According to the American Cancer Society, 10,520 new cases of adult soft tissue
sarcomas will be diagnosed in the United States in 2010. No new therapies have
been approved for use in sarcoma in the U.S. in over 20 years.
Conference Call and Webcast
Tuesday, July 20th at 8:00 a.m. EST
The
Company will host a conference call and live audio webcast Tuesday, July 20th at 8:00
a.m. EST. Dr. Maki will be joining the ZIOPHARM management team in a discussion
regarding the initiation of the pivotal Phase III clinical trial for
palifosfamide (ZymafosTM) in
patients with front-line metastatic soft tissue sarcoma. Also participating in
the call will be Josephine Torrente, attorney with Hyman, Phelps & McNamara,
Washington, DC, as outside regulatory strategic advisor and counsel to ZIOPHARM.
The call can be accessed by calling (877) 375-9144 (U.S. and Canada) or +1 253
237-1150 (international). To access the live audio webcast, or the
subsequent archived recording, visit the “Investors – Events &
Presentations” section of the ZIOPHARM website at www.ziopharm.com. The
webcast will be recorded and available for replay on the company’s website for
two (2) weeks.
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 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.
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
(ZybulinTM 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 the PICASSO 3 trial will complete enrollment within the time period
currently anticipated, that results of the Company’s PICASSO 3 trial
will support the Company's claims, that the Company will obtain regulatory
approval for palifosfamide on an accelerated basis or at all, or that
palifosfamide will be successfully commercialized. Similar risks apply to the
development of the Company’s other product candidates. Other risks that may
affect forward-looking information contained in this press release include 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