PLYMOUTH MEETING, Pa.,
July 23, 2014 /PRNewswire/ -- Inovio
Pharmaceuticals, Inc. (NYSE MKT: INO) today announced successful
results from its randomized, double-blind, placebo-controlled phase
II trial of VGX-3100 in women with biopsy-proven cervical
intraepithelial neoplasia 2/3 (CIN2/3) associated with human
papillomavirus (HPV) types 16 or 18. Treatment with VGX-3100,
Inovio's HPV16/18-specific immunotherapy, resulted in
histopathological regression of CIN2/3 to CIN1 or no disease,
meeting the study's primary endpoint. In addition, the trial
demonstrated clearance of HPV in conjunction with regression of
cervical lesions. Robust T-cell activity was detected in subjects
who received VGX-3100 compared to those who received placebo.
"This is a significant step toward providing women and their
physicians a non-surgical approach to the treatment of precancerous
lesions by stimulating their immune system to eliminate high risk
HPV infection and induce regression of a cervical intraepithelial
neoplastic process," said Mark
Bagarazzi, MD, Chief Medical Officer, Inovio
Pharmaceuticals. "This proof of concept trial will guide the
advancement of VGX-3100 for precancerous dysplasias as well as
HPV-associated cervical, head and neck, and anogenital
cancers."
Treatment was randomized 3:1 between the VGX-3100 and placebo
groups, and was stratified by age and severity of CIN. The primary
endpoint, histologic regression, was evaluated 36 weeks after the
first treatment. In the per protocol analysis, CIN2/3 resolved to
CIN1 or no disease in 53 of 107 (49.5%) women treated with VGX-3100
compared to 11 of 36 (30.6%) who received placebo. This difference
was statistically significant (p<0.025).
Virological clearance of HPV 16 or 18 from the cervix in
conjunction with histopathological regression of cervical dysplasia
to CIN1 or no disease, a secondary endpoint of the trial, was
observed in 43 of 107 (40.2%) VGX-3100 recipients compared to 5 of
35 (14.3%) placebo recipients (p<0.025).
As in the phase I study, VGX-3100 elicited robust HPV-specific T
cell responses in the majority of treated subjects. A comprehensive
analysis of T cell responses is ongoing.
The treatment was generally well-tolerated, with only
administration site redness occurring significantly more frequently
in the VGX-3100 group compared to the placebo group in the 7- and
28-day periods following treatment.
"Beyond the direct clinical implications of this phase II study,
these results are a breakthrough for the field of immunotherapies.
This efficacy and T cell data provide evidence that our
SynCon® immunotherapy technology can activate the immune
system to fight chronic infections, pre-cancers — and ultimately,
cancers," said Dr. J. Joseph Kim,
Inovio's President and CEO. "These results significantly de-risk
our product and business development strategy for VGX-3100 and our
broad pipeline of SynCon® active immune therapy and
vaccine products.
"We thank the women who participated and the clinical
investigators who provided patient care and made this trial
possible."
Topline results will be presented at the 2014 International
Society of DNA Vaccines Conference in San
Diego, on July 23, 2014.
Detailed study findings will be submitted for publication in a
peer-reviewed scientific journal.
About VGX-3100
Inovio's VGX-3100 is an immunotherapy containing two DNA
plasmids targeting the E6 and E7 oncogenes of HPV types 16 and 18.
The treatment is administered to patients by injection into muscle
(typically in the arm), followed by electroporation using Inovio's
CELLECTRA® device. VGX-3100 has been shown to induce a
robust immune response against the E6 and E7 oncogenes associated
with HPV types 16 and 18. These oncogenes are responsible for
transforming HPV-infected cells into pre-cancerous and cancerous
cells. Apart from this cervical dysplasia study, Inovio is also
conducting studies using this immunotherapy against cervical as
well as head and neck cancers caused by these HPV types.
About HPV-003 (ClinicalTrials.gov: NCT01304524; EudraCT:
2012-001334-33)
This phase II trial is a randomized, placebo-controlled,
double-blind study of women with CIN2 or CIN3 who were randomized
3:1 to the active and placebo groups. Women in the active group
received three 6 mg doses of VGX-3100 in a 1 mL intramuscular
injection followed by electroporation with Inovio's CELLECTRA®
device at weeks 0, 4, and 12. Cervical tissue was examined before
starting blinded treatment and 9 months later.
Cornelia Trimble, MD, Associate
Professor of Gynecology and Obstetrics, Oncology, and Pathology,
Johns Hopkins School of Medicine, is
the principal investigator for the study.
About HPV and Cervical Dysplasia
Human papillomavirus (HPV) is the most common sexually
transmitted disease. At any given time, approximately 11% percent
of the world population is infected with HPV. Roughly 90% of HPV
infections are cleared by naturally occurring immune responses
within two years.
Persistent HPV infection can lead to dysplasia, or premalignant
changes, in cervical cells. HPV types 16 and 18 cause 70% of
cervical dysplasia and cervical cancer cases. Each year in
the United States, 1.4 million
women are diagnosed with CIN1 and 300,000-400,000 women are
diagnosed with CIN 2/3. All cervical cancers arise from untreated
CIN2/3.
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,
University of Pennsylvania, 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 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, 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, 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 March 31, 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.