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 the U.S. Food & Drug Administration (FDA)
has accepted the Company's investigational new drug (IND) application to
begin clinical study of ZIN ATI-001, a novel DNA-based therapeutic
candidate also known as Ad-RTS-IL-12 + AL (INXN 2001/1001), in oncology.
When initiated, the Phase I study will evaluate safety in addition to
immunological and biological effects of the therapeutic candidate in
patients with melanoma. ZIN ATI-001 is the second clinical oncology
product candidate from the ZIOPHARM-Intrexon Corporation exclusive
synthetic biology channel partnership.
ZIN ATI-001 employs an adenoviral vector to deliver, directly into the
patient's own cells, a gene which expresses Interleukin-12 (IL-12), a
potent, naturally occurring anticancer cytokine central to the
initiation and regulation of cellular immune responses. Production of
IL-12 within cells is then tightly regulated by the Intrexon RheoSwitch
Therapeutic System™ (RTSTM), a "gene switch" controlled by an
orally administered activator ligand (AL). Preclinical studies have
shown that the immunological mechanism of action of ZIN ATI-001 is
similar to that of ZIN-CTI-001 (DC-RTS-IL-12 + AL), ZIOPHARM's most
advanced DNA-based product candidate, currently in Phase Ib. Positive
clinical data of ZIN-CTI-001, the first-ever to demonstrate small
molecule-controlled production of an anticancer protein in humans, were
recently presented at the 2011 Annual Meeting of the American Society of
"The rapid acceptance of this IND underscores ZIOPHARM's strengths as
our exclusive partner for the development of DNA-based therapeutics in
oncology," stated RJ Kirk, Intrexon's Chairman and CEO, and a Director
of the ZIOPHARM Board of Directors. "ZIN ATI-001, which offers an
effective, yet simpler approach to introducing IL-12 therapy, is the
first of many products we expect to introduce into the clinic as
partners over the next two years. ZIOPHARM's understanding of the
development spectrum, from preclinical work through large outcome
studies, ensures that the great promise of this technology is delivered
quickly and intelligently."
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 is currently focused on several clinical
Palifosfamide (Zymafos™ or 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 is also currently conducting a Phase I
intravenous study of palifosfamide in combination with standard of care
addressing small cell lung cancer and an oral form of the drug for
treatment of solid tumors is currently in the advanced preclinical stage
Darinaparsin (Zinapar™ or ZIO-101) is a novel mitochondrial-targeted
agent (organic arsenic) being developed intravenously for the treatment
of relapsed peripheral T-cell lymphoma likely with a two-stage
potentially pivotal study expected to begin in late 2011. An oral form
is in a Phase I trial in solid tumors.
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
I/II in metastatic breast cancer.
ZIOPHARM is also pursuing the development of novel DNA-based
therapeutics in the field of cancer pursuant to an exclusive channel
partnership with Intrexon Corporation. The partnership includes two
existing clinical-stage product candidates, the first of which is in a
Phase Ib study and the second, entering Phase I study.
ZIOPHARM's operations are located in Boston, MA and Germantown, MD with
an executive office in New York City. Further information about ZIOPHARM
may be found at www.ziopharm.com.
Forward-Looking Safe Harbor Statement:
This press release contains forward-looking statements for ZIOPHARM
Oncology, Inc. that involve risks and uncertainties that could cause
ZIOPHARM Oncology'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 ZIOPHARM Oncology'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 ZIOPHARM Oncology's
product candidates, the risk that the results of clinical trials may not
support ZIOPHARM Oncology's claims, the risk that pre-clinical or
clinical trials will proceed on schedules that are consistent with
ZIOPHARM Oncology's current expectations or at all, risks related to
ZIOPHARM Oncology'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 ZIOPHARM Oncology's ability to obtain additional financing to
support its operations thereafter, as well as other risks regarding
ZIOPHARM Oncology's that are discussed under the heading "Risk Factors"
in ZIOPHARM Oncology's filings with the United States Securities and
Exchange Commission. Forward-looking statements can be identified by the
use of words such as "may," "will," "intend," " should," "could," "can,"
"would," "expect," "believe," "estimate," " predict," "potential,"
"plan," "is designed to," "target" and similar expressions. ZIOPHARM
Oncology assumes no obligation to update these forward-looking
statements, except as required by law.
ZIOPHARM Oncology, Inc.
Tyler Cook, 617-259-1982
David Pitts, 212-600-1902
Source: ZIOPHARM Oncology, Inc.
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