ZIOPHARM Oncology Announces Updated Findings from Phase 1 Study of Ad-RTS-hIL-12 + Veledimex in Recurrent Glioblastoma Presen...
September 18 2017 - 8:00AM
ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company
focused on new immunotherapies, today announced that updated data
from a subset of patients in its Phase 1 multicenter study of
Ad-RTS-hIL-12 + veledimex in patients with recurrent or progressive
glioblastoma (GBM) was presented at the 79th Annual Meeting of the
American Academy of Neurological Surgery (AANS) in Santa Barbara,
CA. Ad-RTS-hIL-12 + veledimex is ZIOPHARM’s adenoviral (Ad) gene
therapy candidate for the controlled expression of human
interleukin-12 (hIL-12), a critical protein for stimulating an
anti-cancer immune response.
“We are seeing additional evidence suggestive of
inflammatory pseudo-progression rather than tumor progression in
patients with recurrent glioblastoma who were biopsied after
administration of Ad-RTS-hIL-12 + veledimex,” said E. Antonio
Chiocca, M.D., Ph.D., Harvey W. Cushing Professor of Neurosurgery,
Department of Surgery, Harvard Medical School, Surgical Director,
Center for Neuro-oncology, Dana-Farber Cancer Institute, Chairman,
Neurosurgery, Brigham and Women's Hospital and Co-Director,
Institute for the Neurosciences, Brigham and Women's Hospital.
“These updated immunohistochemistry data on top of promising
survival underscore the possible immunomodulatory benefits of
localized and controlled IL-12 and support the advancement of this
therapy candidate into a larger outcome study.”
Dr. Chiocca’s oral presentation, “A Phase I
Clinical Trial of Regulated Interleukin-12 Immunogene Therapy for
Recurrent Glioblastoma,” included detail on three biopsied patients
with evidence of documented pseudo-progression rather than tumor
progression. Pseudo-progression may be seen in post-treatment
imaging studies of cancers where the tumor appears larger compared
to baseline, but these changes are due to infiltration of immune
cells, as evidenced by subsequent biopsies. Some GBM lesions on
repeated MRI scans show evidence of progression followed by
regression which is consistent with immune-mediated anti-tumor
effects.
Dr. Chiocca also provided an overview of trial
data previously presented at the 2017 American Society of Clinical
Oncology Annual Meeting from patients receiving intratumoral
Ad-RTS-hIL-12 with 20 mg of orally-administered veledimex (n = 15)
following craniotomy including:
- A median overall survival (mOS) of 12.5 months for patients
with recurrent glioblastoma (GBM) comparing favorably to historical
controls;
- The observed ratio of CD8+/FOXP3+ (effector/suppressor) T cells
suggesting overall survival appears correlated with IL-12-mediated
cellular immune activation; and
- A superior survival rate in the 20mg cohort has been observed
in those patients that received low dose steroids.
A copy of the slides from AANS will be available
following presentation in the Presentations and Publications
section of the Company’s website, http://www.ziopharm.com.
About ZIOPHARM Oncology,
Inc.
ZIOPHARM Oncology is a Boston,
Massachusetts-based biotechnology company employing innovative 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
RheoSwitch Therapeutic System® (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 and our Quarterly Report on Form 10-Q for the quarter
ended June 30, 2017. 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 PittsArgot Partners212-600-1902david@argotpartners.com
Intrexon (NASDAQ:XON)
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