ZIOPHARM Oncology Announces Initiation of Indiana University-Sponsored Phase 2
Study of Palifosfamide in Recurrent and Incurable Germ Cell (Testicular and
NEW YORK, March 6, 2013 (GLOBE NEWSWIRE) -- ZIOPHARM Oncology, Inc.
(Nasdaq:ZIOP), a biopharmaceutical company focused on the development and
commercialization of new cancer therapies, today announced the start of a
multicenter, single arm Phase 2 investigator-sponsored study of palifosfamide
(ZIO-201) in patients with recurrent metastatic germ cell (testicular and
ovarian) tumors who have relapsed on initial platinum-based therapy and high
dose chemotherapy, or patients who are not eligible for high dose
chemotherapy. The study is being conducted at the Melvin and Bren Simon Cancer
Center at the Indiana University, led by Lawrence Einhorn, M.D., Distinguished
Professor of the Department of Medicine, Division of Hematology/Oncology at
the School of Medicine. ZIOPHARM is currently conducting Phase 3 trials of
palifosfamide in first-line metastatic soft tissue sarcoma (PICASSO 3) and
first-line metastatic small cell lung cancer (MATISSE). Dr. Einhorn is the
lead principal investigator for the MATISSE trial. The Company expects to
announce topline results from PICASSO 3 the last week of this month.
"While treatments for germ cell cancers are often effective, and five-year
survival is high, there remains a population for whom relapse or a lack of
tolerability lead to poor prognosis," said Dr. Einhorn. "Palifosfamide is in
the same molecular class as ifosfamide, an agent that has transformed the
treatment of testicular cancer. Our early experience in Phase 1 testing with
palifosfamide in patients with resistant testicular and ovarian germ cell
tumors is quite encouraging. Data from the Phase 2 study will inform us of how
best to advance the use of palifosfamide in these diseases."
The primary endpoint is response rate (CR+PR) of single agent palifosfamide in
patients with refractory germ cell tumors. The secondary endpoints include the
duration of remission, progression-free survival (PFS), overall survival (OS)
and the safety profile of palifosfamide in patients with germ cell tumors. In
this trial, twelve patients will be treated with palifosfamide (150 mg/m^2 3
days every 3 weeks for 6 cycles) and, if at least 1 response (RR of ≥ 8.5%) is
observed, enrollment will continue to a total of twenty patients to evaluate
response rate of single agent palifosfamide. Additionally, the response rate
will be assessed every cycle by RECIST v1.1 and by serum AFP and beta-hCG.
About ZIOPHARM Oncology, Inc.:
ZIOPHARM Oncology is a biopharmaceutical company focused on the development
and commercialization of new cancer therapies. The Company's clinical programs
Palifosfamide (ZIO-201) is a potent bi-functional DNA alkylating agent that
has activity in multiple tumors by evading typical resistance pathways.
Palifosfamide is in the same class as bendamustine, cyclophosphamide, and
ifosfamide. Intravenous palifosfamide is currently being studied in a
randomized, double-blinded, placebo-controlled Phase 3 trial (PICASSO 3) for
the treatment of first-line metastatic soft tissue sarcoma and is also in a
pivotal Phase 3 trial (MATISSE) for first-line metastatic small cell lung
cancer. Additionally, the Company is developing an oral capsule form of
Ad-RTS IL-12 is currently being tested in a Phase 2 study. Ad-RTS IL-12 uses
synthetic biology to enable controlled, local delivery of therapeutic
interleukin-12 (IL-12), a protein important for an immune response to cancer.
ZIOPHARM's DNA synthetic biology platform is being developed in partnership
with Intrexon Corporation and employs an inducible gene-delivery system that
enables controlled, local delivery of genes that produce therapeutic proteins
to treat cancer. This is achieved by placing IL-12 under the control of a
proprietary biological "switch" (the RheoSwitch Therapeutic System^®, RTS^®)
to turn on/off the therapeutic protein expression at the tumor site.
Indibulin (ZIO-301) is a novel, tubulin binding agent that is expected to have
several potential benefits, including oral dosing, application in multi-drug
resistant tumors, no neuropathy and a tolerable toxicity profile. It is
currently being studied in a Phase 1/2 trial in metastatic breast cancer.
Darinaparsin (ZIO-101) is a novel mitochondrial-and hedgehog-targeted agent
(organic arsenic) currently in ongoing studies with Solasia Pharma K.K.
ZIOPHARM's operations are located in Boston, MA, and New York City. Further
information about ZIOPHARM may be found at www.ziopharm.com.
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, Ad-RTS
IL-12, 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, Ad-RTS IL-12, Darinaparsin, Indibulin, and
our other therapeutic products will be successfully marketed if approved;
whether any of our other 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 filed from time to time with the Securities and Exchange
Commission, including but not limited to our Annual Report on Form 10-K for
the fiscal year ended December 31, 2011, and our Quarterly Report on Form 10-Q
for the fiscal quarter ended September 30, 2012. 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
CONTACT: For ZIOPHARM
ZIOPHARM Oncology, Inc.
David Schull or Lena Evans
Russo Partners, LLC
ZIOPHARM Oncology, Inc. Logo
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