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): June 7, 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
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Other
Events.
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On June
7, 2010, the Company issued a press release announcing the presentation of
updated interim data from the Company’s palifosfamide study. The presentation
was made by Dr. Claire Verschraegen of the University of New Mexico,
Albuquerque, first author on the abstract for the Company’s palifosfamide study
entitled “A phase II randomized controlled trial of palifosfamide plus
doxorubicin vs. doxorubicin in patients with soft tissue sarcoma (PICASSO)”, in
an oral session at the American Society of Clinical Oncology (ASCO) Annual
Meeting on Monday, June 7, 2010.
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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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 June 7, 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:
June 7, 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 June 7, 2010
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Exhibit
99.1
ZIOPHARM
Presents Positive Palifosfamide PICASSO
Phase
II Results in Oral Session at ASCO
--
Randomized Phase III Expected to Commence Mid-Year --
New York, NY – June 7, 2010 -
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that Dr. Claire
Verschraegen of the University of New Mexico, Albuquerque and first author of
the abstract, “A phase II randomized controlled trial of palifosfamide plus
doxorubicin vs. doxorubicin in patients with soft tissue sarcoma (PICASSO),”
(Abstract #10004) presented in an oral session today updated positive data from
PICASSO. The presentation was part of the 46th Annual
American Society of Clinical Oncology (ASCO) meeting being held in Chicago, IL,
from June 4th to
8th.
The abstract has also been selected as part of the 2010 Best of ASCO® which
features high-impact abstracts from the ASCO Annual Meeting that represent the
most relevant, cutting-edge science in oncology today.
“The
conclusions from the PICASSO study are that palifosfamide in combination with
doxorubicin is well tolerated, easy to administer and can be given in the
outpatient setting, and is active in soft tissue sarcoma,” commented Dr.
Verschraegen. “We look forward to the initiation of the pivotal Phase III study,
which is designed based on the PICASSO study, and pending regulatory clearance
by FDA through the Special Protocol Assessment process.”
As
previously announced, a total of 67 patients with soft tissue sarcoma (STS) were
randomized with 66 treated and 62 eligible for evaluation. The study was powered
to show a difference in progression free survival (PFS) between doxorubicin in
combination with palifosfamide versus doxorubicin alone. The initial analysis
demonstrated that the hazard ratio (HR) met the specified endpoint and after
consultation with the Data Committee, independent sarcoma experts, and the
Medical Advisory Board, enrollment was stopped and results were subsequently
reported at the 2009 CTOS Annual Meeting. A second and subsequent analysis was
conducted for an end-of-Phase-II meeting with the Food and Drug Administration
(FDA) and those data were reported in the recently published ASCO
abstract.
The
updated study results presented to the FDA reported a hazard ratio of 0.43
favoring the palifosfamide combination with a statistically significant and
clinically meaningful 3.4 month difference in median PFS. An analysis of the
same data, presented today, consisting of those patients receiving either
doxorubicin or doxorubicin in combination with palifosfamide for 6 cycles or
less (the standard treatment period for doxorubicin) reported a hazard ratio of
0.39 (p= 0.023). This analysis also reported results for response rate -- for
the palifosfamide doxorubicin combination 7 of 30 patients (23%) achieved a
response, while for the doxorubicin arm alone; the response rate was 3 of 32
patients (9%). Preliminary survival data, based on a median follow-up of
approximately 9 months, but with a number of patients still on study and data
collection ongoing, showed a survival advantage trending in favor of the
palifosfamide and doxorubicin combination over doxorubicin alone. Updated safety
data showed there was similarity between the arms of the study. The most common
grade 3+ events were neutropenia and elevated creatinine; both observed with
similar frequency between treatment groups. There was no
encephalopathy, hemorrhagic cystitis, nor Fanconi’s Syndrome.
“We are
very thankful to all who have contributed to the success of the PICASSO study
and preparation for the initiation of the Phase III trial (PICASSO III),” added
Jonathan Lewis, MD, PhD, of ZIOPHARM.
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. Palifosfamide does not have the
toxic metabolites of ifosfamide that cause the debilitating side effects of
“fuzzy brain” (encephalopathy) and severe bladder inflammation. It
may also have other advantages. Intravenous palifosfamide is
currently in a randomized Phase II trial to treat unresectable or metastatic
soft tissue sarcoma in the front- and second-line setting with the Company
having reported interim positive results in late 2009; a registration trial in
the same setting is expected to initiate following U.S. Food and Drug
Administration (FDA) review in the first half of this year. An oral form of
palifosfamide has been developed preclinically to the investigational new drug
application stage.
Darinaparsin
(ZinaparTM or
ZIO-101) is a novel
mitochondrial-targeted agent (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. The Company has
reported favorable results from a Phase II trial with IV-administered
darinaparsin in lymphoma, particularly peripheral T-cell lymphoma (“PTCL”), at
the American Society of Clinical Oncology (ASCO) in May of 2009 which would
serve as the basis for ongoing clinical study in PTCL following regulatory
review and available financial resources. Phase I trials with the oral form are
ongoing in both hematological malignancies and solid tumors.
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. 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 last 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; employing this dosage schedule, the Company has
initiated a Phase I study in breast cancer patients with the Breast Cancer
Medicine Service at Memorial Sloan-Kettering Cancer Center.
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. 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:
Dennis
S. Dobson
(203)
258-0159
dsdobson@optonline.net