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): October 15, 2008
ZIOPHARM
Oncology, Inc.
(Exact
Name of Registrant as Specified in its Charter)
|
Delaware
|
0-32353
|
84-1475642
|
|
(State
or Other Jurisdiction of Incorporation)
|
(Commission
File Number)
|
(IRS
Employer Identification No.)
|
1180
Avenue of the Americas, 19th Floor
New
York, NY 10036
(Address
of Principal Executive Offices) (Zip Code)
(646)
214-0700
(Registrant’s
telephone number, including area code)
(Former
name or former address, if changed since last report)
Check
the
appropriate box below if the Form 8-K filing 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 Pre-commencement
communications pursuant to Rule
13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item
8.01. Other Events.
On
October 15, 2008, ZIOPHARM Oncology, Inc. issued the press release attached
hereto as Exhibit 99.1, which is incorporated herein by reference.
Item
9.01. Financial Statements and Exhibits.
(d) Exhibits.
| 99.1 |
Press
Release dated October 15, 2008.
|
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.:
(Registrant)
|
||
| |
|
|
| Date: October 15, 2008 | By: | /s/ Richard E. Bagley |
| Name: | Richard E. Bagley | |
| Title: | President and Chief Operating Officer | |
Exhibit
99.1
ZIOPHARM
Receives Positive Opinion from EMEA for Orphan Medicinal Product
Designation
for Palifosfamide (ZIO-201) in the Treatment of Soft Tissue
Sarcoma
NEW
YORK
- October 15, 2008 - ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), announced today
that the European Medicines Agency’s (EMEA) Committee for Orphan Medicinal
Products (COMP) has issued a positive opinion regarding ZIOPHARM’s application
for orphan medicinal product designation for palifosfamide in the treatment
of
soft tissue sarcoma (STS).
In
the
European Union (EU), products targeted to treat life-threatening or very serious
conditions that affect fewer than five in 10,000 people are eligible for orphan
medicinal product designation. Such status provides significant advantages
and
assistance in obtaining final approval to market palifosfamide in the EU. These
include: Ten year market exclusivity in the EU once the product is approved;
direct assistance from the EMEA in preparing the final protocol for drug
approval; access to EMEA centralized filing procedures for approval in the
EU;
and, reduced fees for EMEA filings.
“There
is
a significant unmet need for additional treatments to address soft tissue
sarcoma beyond locally effective surgery,” said Jonathan Lewis, MD, PhD, and
Chief Executive and Medical Officer of ZIOPHARM. “We are pleased to so soon have
orphan drug status in Europe to augment the Orphan Drug Designation received
in
the United States earlier this year as we initiate patient treatment in our
Phase II randomized controlled trial in STS.”
About
Palifosfamide:
Palifosfamide
(IPM), the active moiety of ifosfamide (IFOS), is a bi-functional alkylator
that
causes irreparable inter-strand DNA cross-linking, resulting in cell death.
Palifosfamide is equal to or more active than IFOS in diverse cancer models.
Unlike IFOS, which is a pro-drug, palifosfamide is directly active against
cancer cells. Also, unlike IFOS, palifosfamide is not metabolized to acrolein
or
chloroacetaldehyde which cause bladder or central nervous system toxicities.
Intravenously (IV) administered palifosfamide is completing a Phase II trial
in
advanced soft tissue and bone sarcomas and a Phase I combination study with
the
FDA approved front-line therapy doxorubicin (Adriamycin®). The Company has
recently initiated treatment in a randomized controlled Phase II trial of
doxorubicin and doxorubicin plus palifosfamide in the front- and second-line
setting of soft tissue sarcoma.
About
European Medicines Agency:
The
EMEA
is a decentralized body of the European Union with headquarters in London.
Its
main responsibility is the protection and promotion of public and animal health,
through the evaluation and supervision of medicines for human and veterinary
use. Further information about EMEA may be found at www.emea.europa.eu.
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 the
development of three clinical programs for multiple indications. Palifosfamide
(ZIO-201) is a novel molecule that is the functional active metabolite of
ifosfamide, a standard of care for treating sarcoma, testicular cancer and
other
cancers. Palifosfamide delivers only the cancer fighting component of
ifosfamide. It overcomes the resistance of ifosfamide and cyclophosphamide
in
certain cancers. It does not have the toxic metabolites that cause the
debilitating side effects of “fuzzy brain” (encephalopathy) and severe bladder
inflammation. Indibulin (ZIO-301) is
a
novel, oral tubulin binding agent that targets both mitosis and cancer cell
migration. Indibulin has several potential benefits, including oral dosing,
application in multi-drug resistant tumors, no neuropathy and minimal overall
toxicity.
Indibulin
has shown early activity in many types of solid tumors. Darinaparsin
(ZIO-101) is
a
novel organic arsenic being developed for the treatment of various hematologic
and solid cancers. Studies demonstrate that darinaparsin is less toxic and
more
active in treating cancer than FDA-approved inorganic arsenic. 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, and risks related to
the
Company's ability to protect its intellectual property and its reliance on
third
parties to develop its product candidates. 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
Melody
Carey
Rx
Communications Group
(917)
322-2571
mcarey@rxir.com