PLYMOUTH MEETING, Pa.,
Jan. 29, 2015 /PRNewswire/
-- Inovio Pharmaceuticals, Inc. (NASDAQ: INO) announced today
it has appointed Mark Stephen
Gelder, M.D. as Vice President, Clinical Development. Dr.
Gelder will be responsible for planning and executing Inovio's
clinical development strategy for its immunotherapies against human
papillomavirus (HPV)-caused cervical cancer and dysplasia. He will
report to Dr. Mark Bagarazzi,
Inovio's Chief Medical Officer.
Dr. Gelder brings well over a decade of experience in the
pharmaceutical industry. Prior to joining Inovio, Dr. Gelder was
Chief Medical Officer at Heron Therapeutics, an oncology-focused
biotechnology company. Dr. Gelder's previous experience includes
leading therapeutic oncology programs at Pfizer, Wyeth and Bayer,
where he was involved in the approval and launch of several cancer
therapeutics. He has led international trials, developed global
product launch plans, and directed the development and execution of
phase I to phase IV studies.
Dr. Gelder received his M.D. from the University of Virginia School of Medicine and
completed residency training in internal medicine and OB/GYN
followed by a gynecologic oncology fellowship. He is a Fellow of
the American College of Physicians and the American College of
Obstetrics and Gynecology and has extensive clinical experience in
both the academic and private practice settings. Prior to joining
the industry, Dr. Gelder was an investigator in multiple clinical
trials and has authored numerous scientific papers in the areas of
women's health and oncology.
Dr. J. Joseph Kim, President and
CEO, said, "We are extremely pleased to bring a gynecology-
oncology expert like Mark Gelder to
lead our HPV immuno-oncology programs. Mark's extensive
global experience in oncology and his standing as a respected
OB/GYN opinion leader will strongly support Inovio as we bring the
first DNA-based immunotherapies for HPV-associated diseases into
medical practice."
In 2014, Inovio reported top-line data from a large, controlled
phase II study showing that VGX-3100 was able to eliminate HPV
infection and cause complete regression of high grade cervical
dysplasia (CIN 2/3). Inovio is taking the steps to publish a paper
with the full data set in a peer-reviewed medical journal this
year. Based on the results of the phase II, Inovio plans to
initiate a phase III study in early 2016.
Inovio has also expanded clinical development of its DNA-based
immune therapy products to treat different HPV types and the many
diseases they cause by conducting clinical trials for
HPV-associated cervical cancer, aero-digestive cancers and head and
neck cancer, the fastest growing cancer in men. Interim safety and
immunogenicity data from these studies are expected in 2015.
About Inovio's Cancer Immunotherapies
Inovio's DNA-based immunotherapy technology uniquely activates
highly potent antigen-specific killer T cells targeting a specific
cancer in the body. The company's technology provides the most
natural interaction with the immune system next to an actual
infection, therefore the activated therapeutic response remains
controlled by the immune system and has to date not triggered
unwanted inflammatory responses. These are ideal characteristics of
an immuno-oncology product. Inovio achieved an industry first with
clinically significant efficacy shown with its VGX-3100 HPV
immunotherapy in a phase II study of cervical precancer. Inovio is
now advancing multiple clinical and R&D stage active
immunotherapies with the potential to address the full spectrum of
precancers and cancers.
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing the fight against cancer and
infectious diseases. Our immunotherapies uniquely activate
best-in-class immune responses to prevent and treat disease, and
have shown clinically significant efficacy 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 Roche,
MedImmune, University of Pennsylvania,
DARPA, Drexel University, NIH, HIV
Vaccines Trial Network, National Cancer Institute, U.S. Military
HIV Research Program, and University of
Manitoba. 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 and our capital resources. 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, but not limited to, the fact that pre-clinical and
clinical results referenced in this release may not be indicative
of results achievable in other trials or for other indications,
that the studies or trials may not be successful or achieve the
results desired, including safety and efficacy for VGX-3100, that
pre-clinical studies and clinical trials may not commence or be
completed in the time periods anticipated, that results from one
study may not necessarily be reflected or supported by the results
of other similar studies and that results from an animal study may
not be indicative of results achievable in human studies), 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 immune
therapy and vaccine products, our ability to advance our portfolio
of immune-oncology products independently, including INO-5150, and
to commence a phase I clinical trial for INO-5150 in the first half
of 2015, 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, our ability to enter into
partnerships in conjunction with our research and development
programs, evaluation of potential opportunities, 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, 2013, our Form 10-Q for the quarter
ended September 30, 2014, 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.com
Media: Jeff Richardson, Inovio
Pharmaceuticals, 267-440-4211, jrichardson@inovio.com
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SOURCE Inovio Pharmaceuticals, Inc.