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 9, 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
May 9,
2008, ZIOPHARM Oncology, Inc. (the “Company”) 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 May 9, 2008.
|
SIGNATURE
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:
May 9, 2008
|
By: | /s/ Richard E. Bagley |
|
Richard
E. Bagley,
|
||
|
President,
Chief Operating Officer and Chief Financial
Officer
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||
Exhibit
Index
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Exhibit
No.
|
Description
|
|
99.1
|
Press
Release dated May 9, 2008.
|
Exhibit
99.1
ZIOPHARM
Receives FDA Orphan Drug Designation for Palifosfamide (ZIO-201) in the
Treatment of Soft Tissue Sarcoma
NEW
YORK
- May 9, 2008 - ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP), announced today that
the
United States Food & Drug Administration (FDA) has granted Orphan Drug
Designation to palifosfamide in the treatment of Soft Tissue Sarcoma (STS).
The
United States Orphan Drug Act of 1983 was created to provide incentives for
companies to develop and market treatments for diseases or conditions affecting
fewer than 200,000 people in the United States. The Orphan Drug designation
provides eligibility for a seven-year period of market exclusivity in the United
States after product approval, an accelerated review process, grant funding,
tax
benefits and an exemption from user fees.
Soft
tissue sarcomas represent a rare and diverse group of tumors that are not well
understood. STS tumors can occur anywhere within the body including muscle,
fat,
nerves, vascular tissue, and other connective tissues. STS tumors account for
about 1% of all cancers in adults and 10% in children. According to Cancer
Statistics and the National Cancer Institute, there are an estimated 12,000
new
cases of sarcomas diagnosed in the United States (US) each year, including
approximately 9,000 cases of soft tissue sarcomas (STS) and 3,000 cases of
bone
sarcomas. Deaths attributable to STS are estimated at 3,500 per year, while
1,200 per year are due to bone sarcomas. Although the annual new incidence
of
sarcoma is relatively low, the prevalence of patients with sarcomas is quite
high, with a 5-year survival rate of STS of 50% to 60%.
“There
is
significant unmet need for additional soft tissue sarcoma treatment beyond
locally effective surgery” said Jonathan Lewis, MD, PhD, and Chief Executive
Officer of ZIOPHARM. “Palifosfamide has demonstrated activity against sarcomas
in heavily pre-treated patients as well as evidencing fewer side effects than
similar treatments used in this setting. We are pleased to have received Orphan
Drug designation and look forward to continuing to work closely with the FDA
in
advancing palifosfamide toward commercialization.”
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 currently completing phase
II
testing in both advanced soft tissue and bone sarcomas, while a recently
initiated phase I combination study with the FDA approved front-line therapy
Adriamycin® (doxorubicin) is ongoing. The final results from these studies will
form the basis for an expected phase II randomized trial in the front- or
second-line setting to initiate late in the third quarter of this year.
Following further preclinical study, an oral form of palifosfamide is expected
to enter phase I study in solid tumors early in 2009.
About
ZIOPHARM Oncology, Inc.
ZIOPHARM
Oncology, Inc. is a biopharmaceutical company engaged in the development and
commercialization of a diverse, risk-sensitive portfolio of in-licensed cancer
drugs to address unmet medical needs. The
Company applies new insights from molecular and cancer biology to understand
the
efficacy and safety limitations of approved and developmental cancer therapies
and identifies proprietary and related molecules for better patient treatment.
For more information, visit www.ziopharm.com.
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.
ZIOP-G
#
#
#
Contacts:
Suzanne
McKenna
ZIOPHARM
Oncology, Inc.
(646)
214-0703
smckenna@ziopharm.com
or
Andrea
Rabney
Argot
Partners
(212)
600-1902
andrea@argotpartners.com