--Additional Patent Issuance for Darinaparsin--
NEW YORK--(BUSINESS WIRE)--
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP) announced today that it has
received an allowance from the European Patent Office for Patent
Application No. 05 821 125.1, entitled "Salts of Isophosphoramide
mustard and analogs thereof as anti-tumor agents" with claims directed
to pharmaceutical compositions of a novel DNA cross-linker (stabilized
active metabolite of ifosfamide), including palifosfamide (Zymafos®
or ZIO-201) and their use in treating cancer. A counterpart patent in
the United States was issued in March 2010, with rights extending to
2029. The patent estate covering palifosfamide compositions, methods of
use and methods of manufacture now include issued patents in the United
States, Australia, Europe, New Zealand and South Africa, as well as
pending applications in the United States and various foreign
jurisdictions.
Palifosfamide is currently being evaluated in an international,
randomized, double-blinded, placebo-controlled Phase 3 trial in
front-line metastatic soft tissue sarcoma referred to as the PICASSO 3
Study. Palifosfamide is also being evaluated in a Phase 1 study in
combination with the standard of care for addressing small cell lung
cancer, and in an oral form in preclinical studies. Orphan Drug
Designation for the treatment of soft tissue sarcoma has been obtained
for palifosfamide in both the United States and the European Union.
ZIOPHARM has also been granted Patent No. 2005274926 by the Australian
Patent Office covering a crystalline form of darinaparsin (Zinapar®
or ZIO-101), pharmaceutical compositions containing such compounds, and
methods for their use in treating cancer. Darinaparsin is a novel
mitochondrial- and hedgehog-targeted agent currently in a solid tumor
Phase 1 study with oral administration. Orphan Drug Designation for the
treatment of peripheral T-cell lymphoma has been obtained for
darinaparsin in the United States and Europe.
"We greatly value a strong intellectual property estate," commented
Caesar Belbel, Chief Legal Officer of ZIOPHARM. "Both this allowance and
recent issuance are evidence of our continued execution of global
development programs."
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-
and hedgehog-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.
Zymafos and Zinapar are registered trademarks of ZIOPHARM Oncology, Inc.
For ZIOPHARM:
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.
News Provided by Acquire Media
