ZIOPHARM Oncology Announces Results of Ad-RTS-hIL-12 + Veledimex in Recurrent Glioblastoma to be Presented at the 2017 ASCO A...
May 17 2017 - 5:16PM
ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP), a biopharmaceutical company
focused on new immunotherapies, today announced that it will
present updated results from its Phase 1, multicenter,
dose-escalation study and 20-mg expansion cohort of Ad-RTS-hIL-12 +
orally administered veledimex in patients with recurrent or
progressive glioblastoma (GBM) at the 2017 American Society of
Clinical Oncology (ASCO) Annual Meeting to be held June 2-6 in
Chicago. Ad-RTS-hIL-12 + veledimex is a novel, viral gene therapy
candidate for the controlled expression of interleukin-12 (IL-12),
a pro-inflammatory cytokine critical for stimulating anti-cancer
immune responses.
As noted in the abstract released today,
subjects with recurrent or progressive grade III or IV glioma
undergoing resection were intratumorally injected with 2 x 1011
adenovirus (Ad) particles and received veledimex for 15 daily
doses, beginning just prior to surgery. The primary endpoint of the
study was safety and tolerability of Ad-RTS-hIL-12 + veledimex,
with secondary endpoints including overall survival. Updated
results will be presented at the meeting on June 5.
Glioblastoma is an aggressive brain tumor
affecting approximately 74,000 people worldwide annually.i,ii
Patients with recurrent GBM typically have a median overall
survival (mOS) of 6-7 months, and overall survival in patients who
have failed temozolomide, bevacizumab or equivalent salvage
chemotherapy, is approximately 3-5 months.iii,iv
“Recurrent glioblastoma is a rapidly progressing
disease with no standard of care and extremely poor prognoses, and
thus there is an urgent need for new treatment options,” said
Francois Lebel, M.D., Executive Vice President, Research and
Development, Chief Medical Officer at ZIOPHARM. “We look forward to
updating results from this study at ASCO and to soon advancing
Ad-RTS-hIL-12 + veledimex into additional treatment settings,
including a stereotactic arm, a pediatric trial in diffuse
intrinsic pontine glioma patients and a combination study with an
immune checkpoint inhibitor. We also continue to assess several
paths for the initiation of a pivotal trial and look forward to
providing updates on this strategy following completion of
discussions with regulators and clinical advisors.”
Details for the poster presentation at ASCO
2017:
Title: Expanded phase I study of
intratumoral Ad-RTS-hIL-12 plus oral veledimex: Tolerability and
survival in recurrent glioblastomaAbstract
Number: 2044Session: Central Nervous
System TumorsDate and Time: Monday, June 5, 2017,
1:15 – 4:45 p.m. CT
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
RheoSwitch Therapeutic System® 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 March 31, 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.
i Mrugala MM. Advances and challenges in the treatment of
glioblastoma: a clinician's perspective. Discov Med.
2013;15:221-230.
http://www.discoverymedicine.com/Maciej-M-Mrugala/2013/04/25/advances-and-challenges-in-the-treatment-of-glioblastoma-a-clinicians-perspective/.
Accessed March 24, 2015. ii McCubrey JA, LaHair MM, Franklin RA.
OSU—0312 in the treatment of glioblastoma. Mol Pharmacol.
2006;70:437-439. iii Omuro, A. Glioblastoma and Other
Malignant Gliomas. A Clinical Review JAMA. 2013 Nov
6;310(17):1842-50. iv Iwamoto et al. Patterns or relapse and
prognosis after bevacizumab failure in recurrent glioblastoma.
Neurology 2009; 73(15):1200-1206
TrademarksRheoSwitch
Therapeutic System® and RTS® are registered trademarks of Intrexon
Corporation.
Contact:
Amy Trevvett
Vice President, Corporate Communications
and Investor Relations
617-502-1881
atrevvett@ziopharm.com
David Pitts
Argot Partners
212-600-1902
david@argotpartners.com
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