NEW YORK--(BUSINESS WIRE)--
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), a drug development company
employing small molecule and synthetic biology approaches to cancer
therapy, today announced that it has submitted an Investigational New
Drug (IND) application to the U.S. Food & Drug Administration (FDA) to
begin clinical study of Ad-RTS-IL-12 (INXN 2001/1001), a novel DNA-based
therapeutic candidate. When initiated, the Phase I study will evaluate
safety in addition to immunological and biological effects of the
therapeutic candidate in patients with melanoma. Ad-RTS-IL12 is the
second clinical oncology product candidate from the ZIOPHARM/Intrexon
Corporation's exclusive, synthetic biology channel partnership.
Through intratumoral injection, Ad-RTS-IL-12 employs an adenoviral
vector (Ad) to deliver directly into the patient's own cells a gene
which expresses Interleukin-12 (IL-12), a potent anticancer cytokine.
Production of IL-12 within the cell is in turn tightly regulated by the
Intrexon RheoSwitch Therapeutic System™ (RTSTM), a "gene
switch" controlled by an activator ligand taken orally. IL-12 is a
naturally occurring regulatory cytokine that has a function central to
the initiation and regulation of cellular immune responses.
"Cancer is a disease of DNA and synthetic biology uses genetic tools to
offer us entirely new approaches to addressing its challenges," said
Mark Thornton, M.D., Ph.D., Executive Vice President and Chief
Development Officer of ZIOPHARM. "IL-12, for example, naturally elicits
an immune response to cancer, but is too toxic to be given as a
recombinant protein. By producing IL-12 in the body with a DNA-based
drug, and using our unique technology to switch this production on or
off with a pill, we expect to achieve therapeutic levels of IL-12
without being limited by the toxicities typically associated with
recombinant therapy. Both Ad-RTS-IL-12 and DC-RTS-IL-12 (INXN
3001/1001), our clinical-stage candidate that employs the patient's
transduced dendritic cells to deliver Ad-RTS-IL-12, represent truly
novel and pioneering treatment."
Data from two preclinical studies of Ad-RTS-IL-12 in various in vivo
cancer models will be presented at the 2011 Annual Meeting of the
American Society of Gene and Cell Therapy (ASGCT), being held May 18-21
in Seattle, Washington. Data from a Phase Ib trial with DC-RTS-IL-12
will be presented at the 2011 Annual Meeting of the American Society of
Clinical Oncology (ASCO) being held June 3-7 in Chicago, Illinois.
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
programs.
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
for addressing small cell lung cancer likely in an adaptive potentially
pivotal trial and an oral form of the drug for treatment of solid tumors
is currently in the advanced preclinical stage of development.
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 an adaptive
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 in metastatic breast cancer with an expected substitution of a
modified dosage form for simpler dosage administration.
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 is currently the subject of an
Investigational New Drug (IND) application filed with the U.S. Food and
Drug Administration.
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.
ZIOP-G
About Intrexon Corporation:
Intrexon Corporation is a privately held synthetic biology company that
employs modular DNA control systems to enhance capabilities, improve
safety and lower cost in human therapeutics, protein production,
industrial products, animal sciences and agricultural biotechnology. The
company's advanced transgene engineering platform enables Better DNA™ by
combining breakthroughs in DNA control systems with corresponding
advancements in modular transgene design, assembly and optimization. The
company is currently using these advanced capabilities to undertake
foremost challenges across the spectrum for biological applications.
More information about the company is available at www.DNA.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 not 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 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
tcook@ziopharm.com
or
Media:
Argot
Partners
David Pitts, 212-600-1902
david@argotpartners.com
Source: ZIOPHARM Oncology, Inc.
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