ZIOPHARM Commences Randomized Phase II Study of Palifosfamide in Soft Tissue Sarcoma

* Reuters is not responsible for the content in this press release.

Fri Sep 5, 2008 7:30am EDT

NEW YORK--(Business Wire)--
ZIOPHARM Oncology, Inc. (NASDAQ: ZIOP), announced today that the
first patient has been dosed in its international Phase II randomized
controlled trial of palifosfamide (ZIO-201) in patients with
soft-tissue sarcoma (STS): This is a Phase II multi-center, parallel
group, randomized study of palIfosfamide plus doxorubicin versus
doxorubiCin in subjects with unresectAble or metastatic Soft-tissue
SarcOma (PICASSO). Approximately 100 evaluable subjects are expected
to be enrolled in this multi-center trial, which is being conducted at
sites in the U.S. and Europe by several key opinion leaders in
sarcoma.

   This Phase II trial will evaluate the clinical benefit of
palifosfamide administered with doxorubicin compared with single-agent
doxorubicin in subjects diagnosed with unresectable or metastatic STS
in the front- or second-line treatment setting. The primary endpoint
is assessment of the difference in progression-free survival between
subjects in the two arms of the trial.

   Sant P. Chawla, M.D., Director, Sarcoma Oncology Center, Santa
Monica, and one of the lead investigators of the study noted, "I am
delighted to announce the dosing of the first patient in this key
combination trial for palifosfamide in front- and second-line patients
following very promising results in previous trials in sarcoma in the
refractory setting. By conducting a randomized controlled Phase II
trial where the primary endpoint is progression-free survival,
ZIOPHARM has optimized its chances of yielding positive results by
aiding in the design and thereby mitigating risk for a Phase III
pivotal trial to follow."

   In May 2008, ZIOPHARM received Orphan Drug Designation from the
U.S. Food and Drug Administration (FDA) for palifosfamide in the
treatment of STS. For more details about this trial, please see
www.clinicaltrials.gov.

   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.

ZIOPHARM Oncology, Inc.
Suzanne McKenna, 646-214-0703
smckenna@ziopharm.com

Copyright Business Wire 2008
Comments (0)
This discussion is now closed. We welcome comments on our articles for a limited period after their publication.