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 4, 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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Written communications pursuant to Rule 425 under the
Securities Act
(17 CFR 230.425).
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Soliciting material pursuant to Rule 14a-12 under the Exchange
Act
(17 CFR 240.14a-12).
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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 June 4, 2009, ZIOPHARM Oncology,
Inc. (the “Company”) held its annual shareholder meeting where the Company
provided shareholders with the presentation attached hereto as Exhibit 99.1,
which is incorporated herein by reference. The presentation was also
made available via real-time webcast on the Company’s website, www.ziopharm.com, and will remain available on the
Company’s website for 90 days, until September 2, 2009.
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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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ZIOPHARM
Oncology, Inc. shareholder presentation dated June 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:
June 4, 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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ZIOPHARM
Oncology, Inc. shareholder presentation dated June
2009
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4
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Exhibit 99.1
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Jonathan Lewis, MD,
PhD
FORWARD-LOOKING STATEMENTS
Some of the
statements made in this presentation are
forward-looking statements. These forward-looking
statements are based upon our current expectations and
projections about future events and generally relate to our
plans, objectives and expectations for the development of
and commercialization of in-licensed cancer drugs. Although
management believes that the plans and objectives reflected
in or suggested by these forward-looking statements are
reasonable, all forward-looking statements involve risks and
uncertainties and actual future results may be materially
different from the plans, objectives and expectations
expressed in this presentation.
forward-looking statements. These forward-looking
statements are based upon our current expectations and
projections about future events and generally relate to our
plans, objectives and expectations for the development of
and commercialization of in-licensed cancer drugs. Although
management believes that the plans and objectives reflected
in or suggested by these forward-looking statements are
reasonable, all forward-looking statements involve risks and
uncertainties and actual future results may be materially
different from the plans, objectives and expectations
expressed in this presentation.
ZIOPHARM Mission and
Strategy
Better cancer medicine.
Low cost small molecules.
Oral and global.
Improved quality of life.
Portfolio of
Mid-Stage Development Candidates
Focus of current resources:
ZymafosTM
(palifosfamide), novel DNA-alkylating
molecule
in
randomized phase II expected to define registration trial 1H 2010;
oral form at IND stage
randomized phase II expected to define registration trial 1H 2010;
oral form at IND stage
To follow:
ZybulinTM
(indibulin), novel oral
tubulin-binding
molecule in phase
I trials expected to enter phase I/II breast cancer trial 2H 2009 with
mathematically-derived dosing schedule (Dr. Norton); nanoparticle
formulation (for oral, IV) in preclinical evaluation
I trials expected to enter phase I/II breast cancer trial 2H 2009 with
mathematically-derived dosing schedule (Dr. Norton); nanoparticle
formulation (for oral, IV) in preclinical evaluation
ZinaparTM
(darinaparsin), novel IV
mitochondrial-targeted
molecule in phase II trials with the potential for registration trial in
1H 2010; oral form in phase I
molecule in phase II trials with the potential for registration trial in
1H 2010; oral form in phase I
ZYMAFOSTM
(palifosfamide)
(palifosfamide)
Palifosfamide
Novel alkylating
molecule; patent applications U.S. and internationally
Anticipated low cost
to manufacture
IV form in
randomized phase II and oral developed for IND
Target indication of
soft-tissue sarcoma (front/second-line setting)
Orphan Drug Designation (soft-tissue
sarcoma) in U.S. and Europe
Palifosfamide
Opportunity
Palifosfamide,
novel DNA alkylating
agent, related to
ifosfamide
and cyclophosphamide family
and cyclophosphamide family
Active preclinically
in diverse cancers including ifosfamide and
cyclophosphamide resistant tumors
cyclophosphamide resistant tumors
Development
premise: less
toxic, more efficacious, enhanced
quality of life, easier to administer than related drugs, cost-effective
quality of life, easier to administer than related drugs, cost-effective
Niche market
development for soft-tissue
sarcoma with estimated
sales potential in the front- and second-line setting of $250 MM
sales potential in the front- and second-line setting of $250 MM
Replacing ifosfamide
in lymphoma $400
MM, and with use in
other
solid tumors (for ifosfamide/cyclophosphamide) including breast,
ovarian and prostate, significant further potential
solid tumors (for ifosfamide/cyclophosphamide) including breast,
ovarian and prostate, significant further potential
Palifosfamide
Development Leading to ASCO
Active in Phase I
with anticipated toxicity
profile
Active in
Phase II advanced sarcoma
Synergistic with
doxorubicin in preclinical
study
US and EU experts
recommend randomized phase
II
(front-/second-
line setting, palifosfamide +/- doxorubicin) in soft-tissue sarcoma
(PICASSO); trial actively enrolling with initial drug study safety
monitoring committee meeting concluding completing trial as planned,
possibly enrolling less patients.
line setting, palifosfamide +/- doxorubicin) in soft-tissue sarcoma
(PICASSO); trial actively enrolling with initial drug study safety
monitoring committee meeting concluding completing trial as planned,
possibly enrolling less patients.
Phase I palifosfamide/doxorubicin
combination data presented at
ASCO 2009
ASCO 2009
Select ASCO data:
A Phase I Study of Palifosfamide
in Combination with Doxorubicin:
Safety and Preliminary Efficacy
in Combination with Doxorubicin:
Safety and Preliminary Efficacy
Luis H.
Camacho1, Sant
Chawla2, Victoria
Chua2, Giovanni
Abbadessa3,
Philip Komarnitsky 3, Barbara Wallner3, Jan Stevens3, Jonathan Lewis3
Philip Komarnitsky 3, Barbara Wallner3, Jan Stevens3, Jonathan Lewis3
1Oncology Consultants; 2Sarcoma Oncology Center, Santa Monica,
CA;
3ZIOPHARM Oncology, Inc., Boston, MA
3ZIOPHARM Oncology, Inc., Boston, MA
Preliminary Exposure and
Efficacy
Efficacy
Exposure
13 treated; 0 ongoing
Best
Response
SD or better in 42% of 12 evaluated patients
3 PR: STS (2) and SCLC (1)
SD or better in 75% of STS patients
Patients age =65 (n=4): 2 SD
(50%), 1 PR (25%)
Soft-Tissue Sarcomas:
Best Response
(N=8)
0
2
0
LMS (2)
0
1
0
MPNS
Tumor
25
1
0
1
0
PD
0
0
Angiosarcoma
0
2
Rhabdomyosarcoma
(2)
50
25
% of STS
patients:
0
0
Pleomorphic
Sarcoma
1
0
Endometrial Stromal
Cell Sarcoma
SD
PR
75 % SD or
better
Adverse events
primarily mild to moderate in severity
No encephalopathy,
no hemorrhagic cystitis, no renal
toxicity
toxicity
Most common adverse
events include:
Neutropenia 6
(46%)
Thrombocytopenia 6
(46%)
Micro
Hematuria 5 (38%)
Anemia 5
(38%)
Nausea 4
(31%)
Vomiting 4
(31%)
Adverse Events
Conclusions
Palifosfamide 150 mg/m2 , 3
times per week combined with
doxorubicin 75 mg/m2 once every 3 weeks is a very well tolerated
outpatient regimen.
doxorubicin 75 mg/m2 once every 3 weeks is a very well tolerated
outpatient regimen.
There has been no encephalopathy, no hemorrhagic
cystitis, no
renal toxicity. Adverse events are primarily hematologic and easy to
manage.
renal toxicity. Adverse events are primarily hematologic and easy to
manage.
Preliminary efficacy:
3/12 PRs
2/8 PRs in
STS 4/8 SD in STS
Ease of administration, favorable toxicity profile, and preliminary
efficacy support further evaluation of this agent in sarcoma. A
randomized, controlled Phase II study in STS comparing
palifosfamide 150 mg/m2 plus doxorubicin 75 mg/m2 vs. doxorubicin
75 mg/m2 alone is in full progress.
efficacy support further evaluation of this agent in sarcoma. A
randomized, controlled Phase II study in STS comparing
palifosfamide 150 mg/m2 plus doxorubicin 75 mg/m2 vs. doxorubicin
75 mg/m2 alone is in full progress.
Palifosfamide
Registration Strategy
Palifosfamide / doxorubicin vs.
doxorubicin in front- and
second-line patients with unresectable or metastatic soft-
tissue sarcoma:
second-line patients with unresectable or metastatic soft-
tissue sarcoma:
Phase II randomized
trial helps shape registration trial
Single registration
trial powered for PFS and survival
(indibulin)
ZybulinTM
Indibulin
Novel oral tubulin
binding agent; issued patents and
applications
applications
Anticipated low cost
to manufacture
Targets cell mitosis
and movement
Expected low
toxicity (no neurotoxicity)
Target indication of
subset of breast cancer
Indibulin
Opportunity
Taxanes widely used
and a more efficacious/less toxic
oral treatment expected to have billion dollar sales
potential
oral treatment expected to have billion dollar sales
potential
Distinct mechanism
and
Oral dosing
Lack of neurotoxicity
Potential
efficacy in tumors with MDR
Treatment
approaches, initially in breast
cancer:
Norton dose density
Combination therapy
Indibulin
Development Leading to ASCO
Single
agent activity in phase
I in
multiple tumor types;
confirmatory activity in phase I PET data; DLT not
reached, minimal toxicity and no neurotoxicity
confirmatory activity in phase I PET data; DLT not
reached, minimal toxicity and no neurotoxicity
Highly
synergistic in preclinical study
Phase I oral capecitabine with oral
indibulin presented at
ASCO 2009
ASCO 2009
Preclinical
evaluation (Dr. Norton) evaluating dose
density schedule presented at ASCO 2009
density schedule presented at ASCO 2009
Select ASCO presented
data:
Indibulin, a Novel Tubulin
Targeting-agent, in
Combination with
Capecitabine, is Suitable for
Mathematically-Optimized
Dose-Scheduling
Targeting-agent, in
Combination with
Capecitabine, is Suitable for
Mathematically-Optimized
Dose-Scheduling
Jonathan J. Lewis
1, Matthew D.
Galsky 2,6, Luis H. Camacho 3, David
M. Loesch 4,6, Philip B. Komarnitsky 1, Barbara Wallner 1, Jan Stevens
Larry Norton 5
M. Loesch 4,6, Philip B. Komarnitsky 1, Barbara Wallner 1, Jan Stevens
Larry Norton 5
1 ZIOPHARM Oncology, New York, NY; 2
Comprehensive Cancer Centers of
Nevada, Las Vegas, NV; 3 Oncology Consultants P.A., Houston, TX; 4 Central
Indiana Cancer Centers, Indianapolis, IN; 5 Harmon Hill, New York, NY, 6 US
Oncology, Translational Oncology Program, Houston, TX
Nevada, Las Vegas, NV; 3 Oncology Consultants P.A., Houston, TX; 4 Central
Indiana Cancer Centers, Indianapolis, IN; 5 Harmon Hill, New York, NY, 6 US
Oncology, Translational Oncology Program, Houston, TX
Preliminary Clinical
Activity
Median SD 6 Cycles
Breast and colon cancer SD for 6 Cycles
Bladder cancer SD for 9 Cycles
Prostate cancer SD for 9 Cycles
Breast and Colon Cancer 6
Cycles
Bladder
and Prostate Cancer 9 Cycles
Preliminary
Safety
AEs that are Related and occurred in
2
or more pts
(
=
29
%)
Frequency,
%
Grade 1/2 AEs that were related
•
Fatigue
4 (57)
•
Anorexia
2 (29)
•
Dyspnea
2 (29)
•
Hand Foot
Syndrome
2 (29)
•
Mucositis
2 (29)
•
Vomiting
2 (29)
Grade 3/4 AEs that were related
•
Hypophosphatemia
1 (14)
Indibulin: Optimization of
Dosing Schedules
Dosing Schedules
Days of Growth
Therapy Starts
(Day 8)
(Day 8)
MX-1 Xenograft
0
500
1000
1500
2000
2500
0
5
10
15
20
25
30
35
Vehicle Control
daily
Indibulin 22 mg/kg
daily
Indibulin 29 mg/kg 5 days on, 5
days off
daily
Indibulin 22 mg/kg
daily
Indibulin 29 mg/kg 5 days on, 5
days off
Indibulin: Optimization of
Dosing Schedules
Dosing Schedules
Conclusions
Oral indibulin in
combination with capecitabine is very
well tolerated with no neurotoxicity. Early activity in
breast, colon, bladder, and prostate cancers.
well tolerated with no neurotoxicity. Early activity in
breast, colon, bladder, and prostate cancers.
Formal analyses of
preclinical data utilizing Norton-
Simon Modeling reveals that the major effect of therapy
occurs in five days of exposure, which is not
manifest on gross inspection until one week thereafter.
Hence, an intermittent schedule based on five days of
drug administration preserves full activity while
minimizing toxicity. This may also minimize acquired
resistance.
Simon Modeling reveals that the major effect of therapy
occurs in five days of exposure, which is not
manifest on gross inspection until one week thereafter.
Hence, an intermittent schedule based on five days of
drug administration preserves full activity while
minimizing toxicity. This may also minimize acquired
resistance.
A Phase I-II study in breast
cancer using this novel
scheduling strategy is in development.
scheduling strategy is in development.
(darinaparsin)
ZinaparTM
Darinaparsin
Novel mitochondrial-targeted agent (organic
arsenic);
first in a new class of molecules
first in a new class of molecules
IV
formulation in multiple phase
I/II studies with
confirmed activity in lymphoma
confirmed activity in lymphoma
Oral form ongoing in Phase I
Families of
compounds covered by issued
patents with
further applications pending in U.S. and internationally
further applications pending in U.S. and internationally
Anticipated
low cost to manufacture
Target
indication of refractory
peripheral T-cell
lymphoma / lymphoma, potential sales of $250 million,
with other lymphoma use, $400 million; with oral form,
significant additional potential
lymphoma / lymphoma, potential sales of $250 million,
with other lymphoma use, $400 million; with oral form,
significant additional potential
Darinaparsin
Opportunity
Inorganic
arsenic use limited by
cardiotoxcity (“Black
Box” warning)
Box” warning)
IV darinaparsin
(organic arsenic) in several phase I/II
studies with no cardiotoxicity, well tolerated; MTD not
yet reached with oral form
studies with no cardiotoxicity, well tolerated; MTD not
yet reached with oral form
IV phase II data
in hematological
malignancies
presented at ASCO 2009 -- advisors believe data can
support potential registration trial
presented at ASCO 2009 -- advisors believe data can
support potential registration trial
Select ASCO Symposium Data:
Novel Organic Arsenic
Molecule Darinaparsin:
Development of IV and Oral
Forms
Molecule Darinaparsin:
Development of IV and Oral
Forms
I. S.
Lossos1, M. D.
Craig2, M. S.
Tallman3, R. V.
Boccia4,
P. R.
Conkling5, C.
Becerra6, P. B.
Komarnitsky7, B.
Wallner7,
J.J.Lewis7, W. H.
Miller8
1 Miller School Of
Medicine, University of Miami, Miami, FL; 2 West Virginia University Hospitals,
Morgantown,
WV; 3 Northwestern University Medical School, Chicago, IL; 4 Associates In Oncology/Hematology,
Bethesda, MD; 5 Virginia Oncology Associates, Norfolk, VA; 6 Baylor University Medical Center,
Dallas, TX; 7 ZIOPHARM Oncology, Inc., Boston, MA; 8 McGill University Jewish General Hospital,
Montreal, QC
WV; 3 Northwestern University Medical School, Chicago, IL; 4 Associates In Oncology/Hematology,
Bethesda, MD; 5 Virginia Oncology Associates, Norfolk, VA; 6 Baylor University Medical Center,
Dallas, TX; 7 ZIOPHARM Oncology, Inc., Boston, MA; 8 McGill University Jewish General Hospital,
Montreal, QC
IV Darinaparsin
Efficacy
Complete Responses: 3
66 year old female, PTCL (3 + months*)
3 prior treatment regimens: CHOP x 6, ICE and
EPOCH x 2
EPOCH x 2
Patient taken off study for autologous BMT
73 year old female, PTCL + senile EBV-associated, B-cell
lymphoproliferative disorder (5 + months)
lymphoproliferative disorder (5 + months)
6 prior regimens: ABVD x 3, ICE, autologous bone
marrow transplant, gemzar and radiation
marrow transplant, gemzar and radiation
65 year old male, DLBCL (6 months)
4 prior regimens: RCHOP, EPOCH, transplant, gemzar
IV Darinaparsin
Efficacy
1 Marginal Zone Non-Hodgkin Lymphoma transformed to DLBCL (14 +
months)*
months)*
5 prior treatment regimens: chlorambucil, RCHOPx5, RICEx3, RT
and BMT
and BMT
1 Marginal Zone Non-Hodgkin Lymphoma (3 months)
Rituximab x 8, RCVP x 1, and gemcitabine x 1
1 PTCL (4 months)
EPOCH x 2, dox, cytoxan
1 Hodgkin’s Nodular Sclerosis (8 months)
ICE x 1, CBV x 1, gemcitabine + MDX x 6
1 PTCL, 2 Hodgkin's, 1 B-cell (3 – 9+ months)
Prolonged Stable Disease:
4
Partial Responses:
4
IV Darinaparsin Related Adverse
Events
Events
Events that were
grade 3
N
%
Fatigue
1
3
Alk. Phos Increased
1
3
Events that were considered SAEs
N
%
Fall
1
3
Neutropenic Fever
1
3
No
QT prolongation
Oral
Efficacy
MTD not reached
1 PR (H&N) duration 5+ months
15 prolonged SD (H&N, lymphoma,
colon, pancreas)
colon, pancreas)
Duration 3 – 6+ months
Summary
IV Lymphoma
7 / 19 objective responses (3 CRs, 4 PRs)
3 / 5 objective responses PTCL (2
CRs, 1 PR)
4 prolonged SD
PO All comers
not yet at MTD
1 PR, 15 prolonged SD
Portfolio
Highlights
Palifosfamide pivotal trial design
expected from IV
phase II randomized study to initiate as early as 1H 2010
and focus of current resources
phase II randomized study to initiate as early as 1H 2010
and focus of current resources
Indibulin phase I and dose
scheduling oral data
highlight potential benefit over widely used tubulin
targeted agents with phase I/II novel dose schedule in
breast expected 2H 2009
highlight potential benefit over widely used tubulin
targeted agents with phase I/II novel dose schedule in
breast expected 2H 2009
Darinaparsin phase II lymphoma
data highly
encouraging for possible registration trial 1H 2010
encouraging for possible registration trial 1H 2010
NASDAQ:ZIOP