NEW YORK--(BUSINESS WIRE)--
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a drug development company
employing small molecule and synthetic biology approaches to cancer
therapy, announced today that results from preclinical studies of
darinaparsin (Zinapar® or ZIO-101), a novel organic arsenic,
in prostate cancer were presented at the AACR-NCI-EORTC International
Conference on Molecular Targets and Cancer Therapeutics, taking place
November 12-16 in San Francisco. In addition to Company authors, the
studies included authors Joseph R. Bertino M.D. and Nitu
Bansal Ph.D. from UMDNJ-The Cancer Institute of New Jersey.
The studies were designed to evaluate the effect of darinaparsin on the
Hedgehog signaling pathway in prostate cancer. Aberrant hedgehog
signaling has been implicated in a number of cancers due to its
association with the transformation of adult stem cells into cancer stem
cells. Data from the studies demonstrate that darinaparsin is a potent
inhibitor of DU145 prostate cells, which inhibited prostate spheroid
growth (IC50:2uM) and prostate stem cell colony formation.
Western analysis showed that darinaparsin decreased levels of the
transcription factor Gli2, a downstream effector of the activated
Hedgehog pathway which is elevated in certain cancers. Further,
combination studies with taxotere, a U.S. Food and Drug
Administration-approved drug for the treatment of patients with advanced
prostate cancer, showed synergistic cell destruction at high fixed doses
of the drugs.
"We know from past research that arsenic trioxide inhibits growth in
certain tumors through its activity against the Hedgehog pathway,"
commented Joseph Bertino, M.D., Associate Director and Chief Scientific
Officer of the Cancer Institute of New Jersey, University Professor of
Medicine and Pharmacology at UMDNJ-Robert Wood Johnson, former President
of AACR and ASCO, and a member of ZIOPHARM's Medical Advisory Board.
"Due to inorganic arsenic trioxide's severe cardiotoxicity and
neurotoxicity profile, darinaparsin, an organic arsenic, was thought to
be a far better treatment candidate and these studies encourage
additional preclinical and clinical study, as a single agent and in
combination."
About ZIOPHARM Oncology, Inc.:
ZIOPHARM Oncology is a biopharmaceutical company engaged in the
development and commercialization of a diverse portfolio of cancer
therapeutics. The Company's small molecule programs include:
Palifosfamide (Zymafos® or ZIO-201) is a novel DNA
cross-linker in class with bendamustine, ifosfamide, and
cyclophosphamide and is currently in a randomized, double-blinded,
placebo-controlled Phase 3 trial with palifosfamide administered
intravenously for the treatment of metastatic soft tissue sarcoma in the
front-line setting. The Company is also currently conducting a Phase 1
study of palifosfamide in combination with standard of care for
addressing small cell lung cancer; an oral form of palifosfamide
continues in preclinical study.
Darinaparsin (Zinapar® or ZIO-101) is a novel
mitochondrial-targeted agent (organic arsenic) currently in a solid
tumor Phase 1 study with oral administration and has been developed
intravenously for the treatment of relapsed peripheral T-cell lymphoma.
Indibulin (Zybulin™ or ZIO-301) is a novel, oral tubulin binding agent
that is expected to have several potential benefits including oral
dosing, application in multi-drug resistant tumors, no neuropathy and a
quite tolerable toxicity profile. It is currently being studied in Phase
1/2 in metastatic breast cancer.
ZIOPHARM is also pursuing the development of novel DNA-based
therapeutics in the field of cancer pursuant to a partnering arrangement
with Intrexon Corporation. The partnership includes two existing
clinical-stage product candidates, both of which are currently in Phase
1.
ZIOPHARM's principal operations are located in Boston, MA with an
executive office in New York City and a small satellite office in
Germantown, MD. Further information about ZIOPHARM may be found at www.ziopharm.com.
ZIOP-G
Forward-Looking Safe Harbor Statement:
This press release contains certain forward-looking information about
ZIOPHARM Oncology that is intended to be covered by the safe harbor for
"forward-looking statements" provided by the Private Securities
Litigation Reform Act of 1995, as amended. Forward-looking statements
are statements that are not historical facts. Words such as "expect(s),"
"feel(s)," "believe(s)," "will," "may," "anticipate(s)" and similar
expressions are intended to identify forward-looking statements. These
statements include, but are not limited to, statements regarding our
ability to successfully develop and commercialize our therapeutic
products; our ability to expand our long-term business opportunities;
financial projections and estimates and their underlying assumptions;
and future performance. All of such statements are subject to certain
risks and uncertainties, many of which are difficult to predict and
generally beyond the control of the Company, that could cause actual
results to differ materially from those expressed in, or implied or
projected by, the forward-looking information and statements. These
risks and uncertainties include, but are not limited to: whether
Palifosfamide, Darinaparsin, Indibulin, or any of our other therapeutic
products will advance further in the clinical trials process and whether
and when, if at all, they will receive final approval from the U.S. Food
and Drug Administration or equivalent foreign regulatory agencies and
for which indications; whether Palifosfamide, Darinaparsin, Indibulin,
and our other therapeutic products will be successfully marketed if
approved; whether our DNA-based biotherapeutics discovery and
development efforts will be successful; our ability to achieve the
results contemplated by our collaboration agreements; the strength and
enforceability of our intellectual property rights; competition from
pharmaceutical and biotechnology companies; the development of and our
ability to take advantage of the market for DNA-based biotherapeutics;
our ability to raise additional capital to fund our operations on terms
acceptable to us; general economic conditions; and the other risk
factors contained in our periodic and interim SEC reports including but
not limited to our Annual Report on Form 10-K for the fiscal year ended
December 31, 2010, our Quarterly Report on Form 10-Q for the quarter
ended September 30, 2011, and our Current Reports on Form 8-K filed from
time to time with the Securities and Exchange Commission. Readers are
cautioned not to place undue reliance on these forward-looking
statements that speak only as of the date hereof, and we do not
undertake any obligation to revise and disseminate forward-looking
statements to reflect events or circumstances after the date hereof, or
to reflect the occurrence of or non-occurrence of any events.
ZIOPHARM Oncology, Inc.
Tyler Cook, 617-259-1982
tcook@ziopharm.com
or
Media:
Argot
Partners
David Pitts, 212-600-1902
david@argotpartners.com
Source: ZIOPHARM Oncology, Inc.
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