ZIOPHARM Announces Successful End-of-Phase 2 Meeting with FDA for Ad-RTS-hIL-12 Gene Therapy in Recurrent Glioblastoma
March 27 2017 - 8:00AM
ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company
focused on new immunotherapies, today announced the receipt of
positive guidance from an End-of-Phase 2 meeting with the U.S. Food
and Drug Administration (FDA) for its lead gene therapy product
candidate, Ad-RTS-hIL-12 plus orally administered veledimex (V), to
harness and control IL-12 production for the investigational
treatment of recurrent glioblastoma (GBM), an aggressive form of
brain cancer with few treatment options.
“We are pleased with our productive interactions
with the FDA and the valuable direction we received at the
End-of-Phase 2 meeting. Our controlled approach utilizing the
RheoSwitch® platform represents the next-generation of gene therapy
enabling IL-12 to be regulated through a transcriptional switch. We
appreciate the FDA’s feedback surrounding our plans to advance
Ad-RTS-hIL-12-based therapy to a pivotal registration study for
patients with recurrent GBM in 2017 and look forward to
establishing the benefits of this novel therapeutic approach,” said
Laurence Cooper, M.D., Ph.D., Chief Executive Officer of
ZIOPHARM.
“The median overall survival remains very
promising and continues to be greater than 12 months for these
heavily compromised patients,” said Francois Lebel, M.D., Chief
Medical Officer of ZIOPHARM. He added, “After positive meetings
with both FDA and European regulators, the Company is working
towards finalization of the optimal pathway for our pivotal trial
for Ad-RTS-hIL-12 + veledimex.”
In collaboration with its investigators and
regulators, the Company is currently assessing its protocol design
options for the pivotal trial, including the potential for a
single-arm study comparing Ad-RTS-hIL-12 + V to historical controls
in a subpopulation of patients with recurrent GBM. Details of the
pivotal Phase 3 trial will be made available following evaluation
and completion of discussions with clinical advisors as well as
regulators.
About Glioblastoma: GBM
represents approximately 15% of all primary brain tumors and
remains a high unmet clinical need that affects roughly 74,000
people worldwide annually. GBM is an aggressive form of brain
cancer with recurrence rates near 90%, and prognosis for patients
is poor with treatment often combining multiple approaches
including surgery, radiation, and chemotherapy. Median overall
survival (OS) is only 6 to 7 months in patients who have
experienced multiple recurrences, and the prognosis is even poorer
for patients who have failed temozolomide and bevacizumab, or
equivalent salvage chemotherapy with a median OS of approximately 3
to 5 months.
About ZIOPHARM Oncology, Inc.:
ZIOPHARM Oncology is a Boston, Massachusetts-based biotechnology
company employing novel gene expression, control and cell
technologies to deliver safe, effective and scalable cell- and
viral-based therapies for the treatment of cancer and
graft-versus-host-disease. The Company's immuno-oncology programs,
in collaboration with Intrexon Corporation (NYSE:XON) and the MD
Anderson Cancer Center, include chimeric antigen receptor T cell
(CAR-T) and other adoptive cell-based approaches that use non-viral
gene transfer methods for broad scalability. The Company is
advancing programs in multiple stages of development together with
Intrexon Corporation's RTS® technology, a switch to turn on and
off, and precisely modulate, gene expression in order to improve
therapeutic index. The Company's pipeline includes a number of
cell-based therapeutics in both clinical and preclinical testing
which are focused on hematologic and solid tumor malignancies.
Forward-Looking Safe-Harbor
Statement:This press release contains certain
forward-looking information about ZIOPHARM Oncology, Inc. 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, and in some cases can be identified
by terms such as "may," "will," "could," "expects," "plans,"
"anticipates," and "believes." These statements include, but are
not limited to, statements regarding the Company's plans and
expectations regarding its securities offerings, fundraising
activities and financial strategy, the progress, timing and results
of preclinical and clinical trials involving the Company's drug
candidates, and the progress of the Company's research and
development programs. 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 by, the forward-looking statements. These risks and
uncertainties include, but are not limited to: our ability to
finance our operations and business initiatives and obtain funding
for such activities, whether chimeric antigen receptor T cell
(CAR-T) approaches, Ad-RTS-hIL-12, TCR and NK cell-based therapies,
or any of our other therapeutic candidates will advance further in
the preclinical or 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 chimeric antigen receptor T cell
(CAR-T) approaches, Ad-RTS-hIL-12, TCR and NK cell-based therapies,
and our other therapeutic products will be successfully marketed if
approved; the strength and enforceability of our intellectual
property rights; competition from other pharmaceutical and
biotechnology companies; and the other risk factors contained in
our periodic and interim 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, 2016. 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.
TrademarksRheoSwitch
Therapeutic System® and RTS® are registered trademarks of Intrexon
Corporation.
Contact:
David Pitts
Argot Partners
212-600-1902
david@argotpartners.com
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