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 promising clinical results from an ongoing
multicenter Phase 1b, open-label, dose escalation study of intravenous
(IV) palifosfamide (Zymafos® or ZIO-201) in combination with
etoposide and carboplatin in patients with small cell lung cancer (SCLC)
and other selected cancers. The data are being presented at the
AACR-NCI-EORTC International Conference on Molecular Targets and Cancer
Therapeutics, being held November 12-16, in San Francisco.
Palifosfamide is a novel DNA cross-linker in class with bendamustine,
ifosfamide, and cyclophosphamide. The ongoing Phase 1b study was
designed to assess the safety and efficacy of palifosfamide in
combination with carboplatin and etoposide (PaCE) in SCLC and other
cancers in which carboplatin plus etoposide is considered an appropriate
therapeutic option. A previous randomized study evaluating the addition
of ifosfamide to cisplatin and etoposide in SCLC demonstrated improved
survival, but with a disabling increase in toxicity with the
combination. The rationale for substituting palifosfamide for ifosfamide
in this three-drug regimen includes the abrogation of
ifosfamide-metabolite related toxicities, an ability to increase the
dose delivered over time, and avoiding resistance mediated by aldehyde
dehydrogenase (ALDH) overexpression. ALDH overexpression is associated
with cancer cell stem-like potential in several tumor types and is
thought to confer resistance to ifosfamide and cyclophosphamide.
A total of 22 patients (11 females and 11 males) have been treated to
date in the study: 7 with SCLC, 3 with non-SCLC, 3 with ovarian cancer,
1 with germ cell tumor and 8 with other cancers. The maximum tolerated
dose of palifosfamide was determined to be 130 mg/m2 when
administered in combination with etoposide (90 mg/m2 with an
additional cohort ongoing at 100 mg/m2) and carboplatin
(AUC4). The dose limiting toxicity was neutropenic fever.
Of the 22 patients, 13 are evaluable for efficacy. Seven are not yet
evaluable for response and 2 patients did not continue beyond cycle 1
due to an adverse event. Among the 13 patients evaluable for efficacy,
there were 5 patients with partial responses (PR), 4 with stable disease
(SD), and 4 with progressive disease (PD). Of the 4 patients with SCLC,
2 showed PR, 1 SD and 1 PD. Partial responses were also seen in non-SCLC
(1), ovarian cancer (1), and germ cell tumor (1).
"I am very enthusiastic about this investigational drug in SCLC.
Ifosfamide, in combination with carboplatin and etoposide, is one of the
few treatments to have demonstrated a survival advantage in SCLC, yet is
often too toxic to be used effectively," said Wael A. Harb, M.D.,
Medical Director of Clinical Research, Indiana University Health Arnett,
Hoosier Oncology Group, and lead author. "The combination with
palifosfamide appears to be well tolerated and has demonstrated
promising clinical activity in SCLC, germ cell tumor and ovarian cancer.
I look forward to participating in the confirmatory study in SCLC."
"Based on past studies and my experience in SCLC, I am encouraged by
these data and the potential of a combination regimen using
palifosfamide, carboplatin and etoposide," said Lawrence Einhorn, M.D.,
Distinguished Professor at the Simon Cancer Center of Indiana University
Medical Center, Lance Armstrong Foundation Chair in Oncology, former
President of ASCO and a member of ZIOPHARM's Medical Advisory Board.
"Small cell lung cancer is a disease in desperate need of an effective
treatment option, as the standard of care has remained unchanged after
decades of research. These early data are not only an important step
forward for palifosfamide in SCLC but also potentially other solid
tumors."
SCLC is almost exclusively associated with cigarette smoking and the
majority of patients with extensive disease are treated front-line but
relapse with a very high mortality within one year. According to the
American Cancer Society, approximately 15 percent of lung cancers are
SCLC, or an incidence of approximately 33,400 patients yearly in the
U.S. There is expected to be a substantially growing incidence worldwide.
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.
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.
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