NEW YORK--(BUSINESS WIRE)--
ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP), announced today that The
Committee for Orphan Medicinal Products (COMP) within the European
Medicines Agency (EMA) adopted a positive opinion for darinaparsin
(Zinapar™ or ZIO-101) designation as an orphan medicinal product for the
treatment of peripheral T-cell lymphoma (PTCL). A positive opinion by
the COMP immediately precedes official designation of darinaparsin as an
orphan drug by the European Commission (EC). Intravenous darinaparsin
has demonstrated evidence of activity in lymphoma, in particular PTCL.
ZIOPHARM expects to initiate a registration-directed study of
darinaparsin in patients with PTCL by the end of 2011.
"Orphan designation recognizes the acute need for new therapies for
unmet medical needs, in this case addressing PTCL, an aggressive form of
lymphoma for which there remains such a need," said Jonathan Lewis,
M.D., Ph.D., Chief Executive Officer and Chief Medical Officer of
Orphan Drug Designation by the EC provides regulatory and financial
incentives for companies to develop and market therapies that treat a
life-threatening or chronically debilitating condition affecting no more
than five in 10,000 persons in the European Union (EU). In addition to a
10-year period of marketing exclusivity in the EU after product
approval, Orphan Drug Designation provides companies with scientific
advice and regulatory assistance from the EMA during the product
development phase, direct access to centralized marketing authorization,
as well as reductions in certain fees associated with the application
and approval process.
In September, ZIOPHARM announced that darinaparsin was granted Orphan
Drug Designation by the U.S. Food and Drug Administration (FDA) for the
treatment of PTCL.
Peripheral T-cell Lymphoma represents a subgroup of aggressive lymphomas
that develop from T-cells in different stages of maturity. According to
the Lymphoma Research Foundation, PTCL accounts for approximately 10-15%
of the estimated 66,000 new cases of non-Hodgkin's lymphoma diagnosed
each year in the United States (53,000 in the EU, according to the
European Cancer Observatory). PTCL generally affects people of the age
of 60 and is diagnosed in more men than women.
About ZIOPHARM Oncology, Inc.:
ZIOPHARM Oncology is a biopharmaceutical company engaged in the
development and commercialization of a diverse portfolio of cancer
drugs. The Company is currently focused on three clinical programs.
Palifosfamide (ZymafosTM 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
expects to initiate an additional study with drug in the oral form
treating solid tumors.
Darinaparsin (ZinaparTM or ZIO-101) is a novel
mitochondrial-targeted agent (organic arsenic) being developed
intravenously for the treatment of peripheral T-cell lymphoma with a
pivotal study expected to begin in late 2011. An oral form is in a Phase
I trial in solid tumors.
Indibulin (ZybulinTM 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 minimal overall toxicity. 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 a partnering arrangement
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 of which is the basis of an Investigational New
Drug application that ZIOPHARM expects to submit during the first half
ZIOPHARM's operations are located in Boston, MA 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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