Full Press Release Details
Granted Japanese Patent for Darinaparsin
New York, NY - September 27, 2010 - ZIOPHARM Oncology, Inc.
(Nasdaq: ZIOP) today announced that the Japanese Patent Office has issued a
patent, Patent No. 4,571,408, with claims covering pharmaceutical compositions,
including oral formulations, of various organic arsenic compounds, including
darinaparsin (ZinaparTM or
ZIO-101), and the use of these compositions and the organic arsenic compounds
for the treatment of cancer, including as part of a combination
recently announced that it has received Orphan Drug Designation from the U.S.
Food and Drug Administration (FDA) for darinaparsin in the treatment of
peripheral T-cell Lymphoma (PTCL). Darinaparsin demonstrated favorable results
in a Phase II trial in lymphoma, particularly PTCL. The Company expects to begin
enrolling patients imminently in a Phase I study of darinaparsin in combination
with CHOP (Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone), the
current standard of care for front-line PTCL, to confirm the tolerability of the
combination. Subject to the outcome of this study and further dialogue with the
FDA, the Company expects to move forward with a registration study of the
darinaparsin and CHOP combination for the front-line treatment of PTCL in late
2011. ZIOPHARM has also recently reinitiated a Phase I study of oral
darinaparsin in advanced solid tumors.
ZIOPHARM Oncology, Inc.:
Oncology is a biopharmaceutical company engaged in the development and
commercialization of a diverse portfolio of cancer drugs. The Company is
currently focused on three clinical programs.
ZIO-201) is a novel DNA cross-linker in class with bendamustine, ifosfamide, and
cyclophosphamide. ZIOPHARM is currently enrolling patients in a
randomized, double-blinded, placebo-controlled Phase III trial with
palifosfamide administered intravenously for the treatment of metastatic soft
tissue sarcoma in the front-line setting. The Company expects to initiate
additional studies in the near-term, including a Phase I IV study of
palifosfamide in combination with standard of care addressing small cell lung
cancer and a Phase I study of oral palifosfamide.
ZIO-101) is a novel mitochondrial-targeted agent (organic arsenic) being
developed intravenously for the treatment of peripheral T-cell lymphoma with a
pivotal study expected to begin in late 2011, following the outcome of a
supporting trial. An oral form is in a Phase I trial in solid
ZIO-301) is a novel, oral tubulin binding agent that targets both mitosis and
cancer cell migration. Indibulin is expected to have several potential benefits
including oral dosing, application in multi-drug resistant tumors, no neuropathy
and minimal overall toxicity. It is currently being studied in Phase I/II in
metastatic breast cancer.
operations are located in Boston, MA with an executive office in New York City.
Further information about ZIOPHARM may be found at
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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, the risk that pre-clinical
or clinical trials will proceed on schedules that are consistent with the
Company's current expectations or at all, risks related to the Company's ability
to protect its intellectual property and its reliance on third parties to
develop its product candidates, risks related to the sufficiency of existing
capital reserves to fund continued operations for a particular amount of time
and uncertainties regarding the Company's ability to obtain additional financing
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