Inovio Announces FDA Request for Additional Information For Phase III Program; Trial Initiation Delayed
October 24 2016 - 8:00AM
Inovio Pharmaceuticals, Inc. (NASDAQ:INO) today announced that the
U.S. Food and Drug Administration (FDA) has placed a clinical hold
on its proposed phase III clinical program for VGX-3100. A clinical
hold is a notification issued by the FDA to a trial sponsor to
delay a proposed clinical trial or suspend an ongoing clinical
trial. This study has not yet been initiated and has not enrolled
or dosed subjects. Additionally, the hold does not pertain to any
of Inovio’s other ongoing clinical studies.
Inovio anticipates receiving a formal letter
with complete information from the FDA within 30 days. In its
initial communication, the FDA has requested additional data to
support the shelf-life of the newly designed and manufactured
disposable parts of the CELLECTRA® 5PSP immunotherapy delivery
device. Inovio is working diligently with the FDA to address its
concerns and anticipates that the requested data will be available
before the end of this year. Inovio estimates that the start of the
phase III clinical program will be delayed until the first half of
2017 pending resolution of the FDA’s requests.
About Inovio Pharmaceuticals,
Inc.
Inovio is taking immunotherapy to the next level
in the fight against cancer and infectious diseases. We are the
only immunotherapy company that has reported generating T cells in
vivo in high quantity that are fully functional and whose killing
capacity correlates with relevant clinical outcomes with a
favorable safety profile. With an expanding portfolio of immune
therapies, the company is advancing a growing preclinical and
clinical stage product pipeline. Partners and collaborators include
MedImmune, The Wistar Institute, University of Pennsylvania, DARPA,
GeneOne Life Science, Plumbline Life Sciences, Drexel University,
NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S.
Military HIV Research Program, and Laval University. For more
information, visit www.inovio.com.
This press release contains certain
forward-looking statements relating to our business, including our
plans to develop electroporation-based drug and gene delivery
technologies and DNA vaccines, our expectations regarding our
research and development programs. Actual events or results may
differ from the expectations set forth herein as a result of a
number of factors, including uncertainties inherent in pre-clinical
studies, clinical trials and product development programs,
including our ability to obtain a release of the clinical hold from
the FDA, the availability of funding to support continuing research
and studies in an effort to prove safety and efficacy of
electroporation technology as a delivery mechanism or develop
viable DNA vaccines, our ability to support our broad pipeline of
SynCon® active immunotherapy and vaccine products, the ability of
our collaborators to attain development and commercial milestones
for products we license and product sales that will enable us to
receive future payments and royalties, the adequacy of our capital
resources, the availability or potential availability of
alternative therapies or treatments for the conditions targeted by
the company or its collaborators, including alternatives that may
be more efficacious or cost effective than any therapy or treatment
that the company and its collaborators hope to develop, issues
involving product liability, issues involving patents and whether
they or licenses to them will provide the company with meaningful
protection from others using the covered technologies, whether such
proprietary rights are enforceable or defensible or infringe or
allegedly infringe on rights of others or can withstand claims of
invalidity and whether the company can finance or devote other
significant resources that may be necessary to prosecute, protect
or defend them, the level of corporate expenditures, assessments of
the company's technology by potential corporate or other partners
or collaborators, capital market conditions, the impact of
government healthcare proposals and other factors set forth in our
Annual Report on Form 10-K for the year ended December 31, 2015,
our Form 10-Q for the quarter ended June 30, 2016, and
other regulatory filings from time to time. There can be no
assurance that any product in Inovio's pipeline will be
successfully developed or manufactured, that final results of
clinical studies will be supportive of regulatory approvals
required to market licensed products, or that any of the
forward-looking information provided herein will be proven
accurate.
CONTACTS:
Investors: Bernie Hertel, Inovio
Pharmaceuticals, 858-410-3101,
bhertel@inovio.comMedia:
Jeff Richardson, Inovio Pharmaceuticals, 267-440-4211,
jrichardson@inovio.com
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