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): May 30, 2009
ZIOPHARM
Oncology, Inc.
(Exact
Name of Registrant as Specified in Charter)
|
Delaware
|
0-32353
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84-1475672
|
||
|
(State
or Other Jurisdiction
of
Incorporation)
|
(Commission
File Number)
|
(IRS
Employer
Identification
No.)
|
|
1180
Avenue of the Americas
19th
Floor
New
York, NY
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10036
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|
|
(Address
of Principal Executive Offices)
|
(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
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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 7.01
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Regulation FD
Disclosure
|
On May
30, 2009, ZIOPHARM Oncology, Inc. (the “Company”) issued a press release
announcing that it presented positive data from both a Phase Ib clinical trial
and preclinical dosing studies of orally administered indibulin (ZybulinTM or
ZIO-301), the Company’s novel tubulin binding agent, as part of the 45th Annual
American Society of Clinical Oncology (ASCO) meeting held in Orlando, FL, May
29th
to June 2nd (the
“ASCO Meeting”).
On May
31, 2009, the Company issued a press release announcing that it presented final
data from a Phase I study of palifosfamide (ZymafosTM or
ZIO-201) in combination with doxorubicin at the ASCO Meeting.
Copies of
the above referenced press releases are furnished as Exhibit 99.1 and 99.2 to
this Current Report of Form 8-K.
In
accordance with General Instruction B.2 of Form 8-K, the information in this
Report, including Exhibits 99.1 and 99.2 shall not be deemed “filed” for the
purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or
otherwise subject to the liabilities of that section, nor shall they be deemed
incorporated by reference in any filing under the Securities Act of 1933, as
amended, except as shall be expressly set forth by specific reference in such a
filing.
|
Item 8.01
|
Other
Events
|
On June
1, 2009, the Company issued a press release announcing that
it presented positive data from both Phase II intravenous (IV) and Phase I oral
studies of darinaparsin (ZinaparTM or
ZIO-101), the novel organic arsenic molecule, at the ASCO Meeting.
A copy of
the above referenced press release is filed as Exhibit 99.3 to this Current
Report of Form 8-K.
|
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.
|
Description
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|
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99.1
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Press
Release of the Company dated May 30, 2009
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|
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99.2
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Press
Release of the Company dated May 31, 2009
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|
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99.3
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Press
Release of the Company dated June 1,
2009
|
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.
|
ZIOPHARM
Oncology, Inc.
|
||
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By:
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/s/
Richard Bagley
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|
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Date:
June 1, 2009
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Name:
Richard Bagley
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|
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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.
|
Description
|
|
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99.1
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Press
Release of the Company dated May 30, 2009
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|
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99.2
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Press
Release of the Company dated May 31, 2009
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|
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99.3
|
Press
Release of the Company dated June 1,
2009
|
4
Exhibit
99.1
—
ZIOPHARM PRESENTS POSITIVE INDIBULIN TRANSLATIONAL
AND
DOSE SCHEDULING DATA AT ASCO —
Orlando, FL – May 30, 2009 -
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that it presented
positive data from both a Phase Ib clinical trial and preclinical dosing studies
of orally administered indibulin (ZybulinTM or
ZIO-301), the Company’s novel tubulin binding agent, at the 45th Annual
American Society of Clinical Oncology (ASCO) meeting held in Orlando, FL, May
29th
to June 2nd.
In the
Phase Ib study, oral indibulin was administered with oral capecitabine
(XelodaTM) in
patients with advanced solid tumors. Trial results presented are for 7 patients
who had received a median of three prior therapies. All 7 patients were
evaluable for safety, and 4 for efficacy. Three patients had stable disease for
a minimum of 6 cycles with 1 patient ongoing in their 11th cycle
of treatment. There were no dose limiting toxicities and therefore no maximum
tolerated dose was established. Adverse events included hand-and-foot syndrome
(capecitabine), fatigue, vomiting, loss of appetite and headaches, and were
easily managed. There was no reported neurotoxicity, consistent with other Phase
I and preclinical data with indibulin. There was early activity seen in breast,
colon, bladder and prostate cancers with this sub-optimal dose level and
schedule, which is encouraging with regard to further study using
mathematically-optimized dose scheduling, the subject of the preclinical data
also presented.
The
preclinical results were derived from mathematical modeling applying
Norton-Simon models in breast cancer xenografts. The work was conducted by the
Company under the direction of Dr. Larry Norton (Harmon Hill). Formal analyses
revealed that the major effect of therapy occurs in five days of exposure, which
is not manifest on gross inspection until one week thereafter. Therefore an
intermittent schedule based on five days of drug administration preserves full
activity while minimizing the possibility of toxicity. A Phase I/II study in
breast cancer using this highly novel scheduling strategy is in development
under the direction of two leading breast cancer specialists, Dr. Clifford Hudis
in the United States and Dr. Jose Baselga in Spain.
“Indibulin
is not only an interesting drug because it is active against taxane-resistant
cells without the neurotoxicity seen with all the other tubulin binding agents,
but also because mathematical modeling has revealed a novel dose-schedule that
promises to maximize efficacy and minimize toxicity in the clinic. Also, it is
oral, so it is potentially of value to the entire world’s population”, commented
Dr. Larry Norton, senior author on this presentation.
To view
the presentation please visit:
http://www.ziopharm.com/docs/Indibulin_Poster_ASCO_2009.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 comprises the
functional active metabolite of ifosfamide, a standard of care for treating
sarcoma, testicular and other cancers. Palifosfamide delivers only the cancer
fighting component of ifosfamide. It is expected to overcome the resistance of
ifosfamide and cyclophosphamide in certain cancers. It does not have the toxic
metabolites of ifosfamide that cause the debilitating side effects of “fuzzy
brain” (encephalopathy) and severe bladder inflammation. Intravenous (IV)
palifosfamide is currently in a Phase II randomized trial to treat soft tissue
sarcoma. An oral form of palifosfamide has been developed
preclinically.
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. Indibulin has
shown early activity in Phase I study as a single agent in many types of solid
tumors. Indibulin is also completing Phase I trials in combination with Tarceva®
and Xeloda®. Oral indibulin preclinical “dose density” and “metronomic” dose
administration studies with our consultant Dr. Larry Norton have progressed to
the point of translation with the intention of further pursuit in clinical
study.
Darinaparsin
(ZinaparTM or
ZIO-101) is a novel
organic arsenic being developed for the treatment of various hematologic and
solid cancers. Preclinical and Phase I and II results to date demonstrate that
darinaparsin is much less toxic than other forms of arsenic. Intravenous
darinaparsin continues to be studied in a Phase II hematology trial with
favorable treatment activity in certain lymphomas and in Phase I study with oral
administration. Darinaparsin has been well tolerated in all trials to
date.
ZIOPHARM’s
operations are located in Boston, MA with an executive office in New York.
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, 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
or
Dennis
Dobson
International
Investor Relations Inc.
(203)
258-0159
dsdobson@optonline.net
Exhibit
99.2
ZIOPHARM
PRESENTS POSITIVE DATA FROM PHASE I STUDY OF
PALIFOSFAMIDE
IN COMBINATION WITH DOXORUBICIN AT ASCO
—
Continued Safety and Activity Strongly Support Ongoing
Phase
II Randomized Trial —
Orlando, FL – May 31, 2009 -
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that it presented final
data from a Phase I study of palifosfamide (ZymafosTM) in
combination with doxorubicin at the 45th Annual
American Society of Clinical Oncology (ASCO) meeting held in Orlando, FL, May
29th
to June 2nd.
The Phase
I trial of palifosfamide in combination with doxorubicin was fully enrolled with
13 patients, predominantly with soft tissue sarcoma and non-small cell lung
cancer, and who had received a median of two prior therapies. Of 12 evaluable
patients, there were 3 partial responses. Of the 8 patients with soft tissue
sarcoma (STS) 75 percent had stable disease or better, with 2 having partial
responses and 4 having prolonged stable disease. The median progression free
survival (PFS) was 19 weeks.
The
combination has proven to be easily administered and was well tolerated with no
dose-limiting toxicities during a total of 73 cycles of treatment. Importantly,
there were no reported events of encephalopathy, hemorrhagic cystitis or renal
toxicity often associated with some current treatments for
STS. Adverse events were primarily hematologic, including neutropenia
and thrombocytopenia, and were managed easily. The
pharmacokinetic evaluation in this trial indicates that palifosfamide exposure
is comparable to that seen in murine models that resulted in marked synergy with
doxorubicin.
The
Company is now enrolling into a Phase II randomized controlled trial comparing
palifosfamide plus doxorubicin vs. doxorubicin in the front- and second-line
treatment setting of STS. This is a multicenter, multinational trial
in the United States and Europe. The objective of the randomized
Phase II trial is to validate certain hypotheses that would form the basis for a
registration trial to be initiated as early as the first half of next
year.
“These
highly favorable Phase I data of palifosfamide in combination with doxorubicin
established the foundation for the now ongoing Phase II randomized trial in the
front and second-line setting”, commented Sant Chawla, MD, co-principal
investigator. “Data has previously been reported on the
activity of palifosfamide as a single agent in advanced sarcoma as well as the
established synergy of palifosfamide with doxorubicin
preclinically. With so few treatment options, I look forward to
ZIOPHARM initiating the final phase of the drug development program that could
establish the first new front-line sarcoma therapy in decades and as well to
advancing into the clinic an oral form for much expanded patient
access.”
To view
the presentation please visit:
http://www.ziopharm.com/docs/Palifosfamide_Poster_ASCO_2009.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 comprises the
functional active metabolite of ifosfamide, a standard of care for treating
sarcoma, testicular and other cancers. Palifosfamide delivers only
the cancer fighting component of ifosfamide. It is expected to overcome the
resistance of ifosfamide and cyclophosphamide in certain cancers. It does not
have the toxic metabolites of ifosfamide that cause the debilitating side
effects of “fuzzy brain” (encephalopathy) and severe bladder inflammation.
Intravenous (IV) palifosfamide is currently in a Phase II randomized trial to
treat soft tissue sarcoma. An oral form of palifosfamide has been
developed preclinically.
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. Indibulin has
shown early activity in Phase I study as a single agent in many types of solid
tumors. Indibulin is also completing Phase I trials in combination
with Tarceva® and Xeloda®. Oral indibulin preclinical “dose density”
and “metronomic” dose administration studies with our consultant Dr. Larry
Norton have progressed to the point of translation with the intention of further
pursuit in clinical study.
Darinaparsin
(ZinaparTM or
ZIO-101) is a novel
organic arsenic being developed for the treatment of various hematologic and
solid cancers. Preclinical and Phase I and II results to date demonstrate that
darinaparsin is much less toxic than other forms of arsenic. Intravenous
darinaparsin continues to be studied in a Phase II hematology trial with
favorable treatment activity in certain lymphomas and in Phase I study with oral
administration. Darinaparsin has been well tolerated in all trials to
date.
ZIOPHARM’s
operations are located in Boston, MA with an executive office in New York.
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, 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
or
Dennis
Dobson
International
Investor Relations Inc.
(203)
258-0159
dsdobson@optonline.net
Exhibit
99.3
ZIOPHARM
PRESENTS POSITIVE DARINAPARSIN CLINICAL DATA AT
ASCO’S
PRESTIGIOUS CLINICAL SCIENCE SYMPOSIUM
—
Phase II Results Possible Basis for FDA Dialogue
Regarding
Registration Trial —
Orlando, FL – June 1, 2009 -
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that it presented
positive data from both Phase II intravenous (IV) and Phase I oral studies of
darinaparsin (ZinaparTM or
ZIO-101), the novel organic arsenic molecule, as part of the prestigious
Clinical Cancer Symposia at the 45th Annual
American Society of Clinical Oncology (ASCO) meeting held in Orlando, FL, May
29th
to June 2nd.
The study
results were presented at the Clinical Science Symposium, New Agents for
Lymphoma, by Izidore S. Lossos, M.D, Chief of the Lymphoma Program, and
Professor of Medicine at the University of Miami Miller School Of
Medicine. Darinaparsin was one of three new drugs selected at this
high profile ASCO session.
“This
drug is active in highly-refractory lymphoma patients and well tolerated,”
commented Dr. Lossos, lead investigator for the Phase II
trial. “Interestingly a lot of patients I and others have treated
with this drug report feeling the best they have felt since first getting
lymphoma, having been on many different treatments. The oral data are
also promising and darinaparsin could well be effective in treating other
cancers as well.”
The Phase
II intravenous (IV) study is fully enrolled with 29 heavily pretreated lymphoma
patients. Of 19 evaluable patients, initial findings are 7 objective responses,
for an overall response rate of 37 percent, with 3 complete responses (CRs) and
4 partial responses (PRs). Four additional patients had prolonged
stable disease (SD). There are 5 peripheral T-cell lymphoma (PTCL)
patients included in the 19 patients and in this group there were 3 objective
responses, for an overall response rate of 60 percent, of which there were 2 CRs
and 1 PR. Of the 4 patients with stable disease, 1 patient had
PTCL. Darinaparsin was very well tolerated with neutropenic fever as
a severe adverse event in 1 patient.
On the
advice of multiple experts, the Company intends, on complete review of the final
data, to open dialogue with the U.S. Food and Drug Administration with a view of
entering into a formal registration trial, likely for peripheral T-cell lymphoma
where, even with other agents under evaluation, there remains a very high unmet
medical need.
The two
Phase I oral dose escalation studies included patients with all types of
cancers. Darinaparsin was dosed with various
schedules. The study included 36 patients. The study has not yet
reached MTD. Of 27 evaluable patients, 1 had a partial response (head
and neck cancer) and 15 had prolonged stable disease, including head and neck,
lymphoma, colon, and pancreatic cancers. Oral darinaparsin was well tolerated
with atrial fibrillation, congestive heart failure and dyspnea as severe adverse
events.
Treatment
with darinaparsin has not evidenced any QT prolongation in either the IV or oral
studies. QT prolongation has been problematic with inorganic arsenic
and is a “black box” side effect warning in the labeling. The Company continues
dialogue regarding partnering and other initiatives regarding the further
clinical development of darinaparsin.
To view
the presentation please visit:
http://www.ziopharm.com/docs/Darinaparsin_2009_ASCO_Symposium_Presentation.ppt
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, testicular and other cancers. Palifosfamide delivers only
the cancer fighting component of ifosfamide. It is expected to overcome the
resistance of ifosfamide and cyclophosphamide in certain cancers. It does not
have the toxic metabolites of ifosfamide that cause the debilitating side
effects of “fuzzy brain” (encephalopathy) and severe bladder inflammation.
Intravenous (IV) palifosfamide is currently in a Phase II randomized trial to
treat soft tissue sarcoma. An oral form of palifosfamide has been
developed preclinically.
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. Indibulin has
shown early activity in Phase I study as a single agent in many types of solid
tumors. Indibulin is also completing Phase I trials in combination
with Tarceva® and Xeloda®. Oral indibulin preclinical “dose density”
and “metronomic” dose administration studies with our consultant Dr. Larry
Norton have progressed to the point of translation with the intention of further
pursuit in clinical study.
Darinaparsin
(ZinaparTM or
ZIO-101) is a novel
organic arsenic being developed for the treatment of various hematologic and
solid cancers. Preclinical and Phase I and II results to date demonstrate that
darinaparsin is much less toxic than other forms of arsenic. Intravenous
darinaparsin continues to be studied in a Phase II hematology trial with
favorable treatment activity in certain lymphomas and in Phase I study with oral
administration. Darinaparsin has been well tolerated in all trials to
date.
ZIOPHARM’s
operations are located in Boston, MA with an executive office in New York.
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, 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
or
Dennis
Dobson
International
Investor Relations Inc.
(203)
258-0159
dsdobson@optonline.net