BLUE BELL, Pa., June 11, 2014 /PRNewswire/ -- Inovio
Pharmaceuticals, Inc. (NYSE MKT: INO) wishes to clarify that a
third party article published on June 10,
2014, was misrepresentative of facts and can only be taken
as malicious. The referenced article does not reflect the progress,
status, and potential of Inovio's active immune therapy technology
and products and is rife with false and misleading conjecture.
As previously communicated on multiple earnings calls and in
other public forums, Inovio has indicated that it expects to report
mid-year the top-line results of its phase II clinical trial
evaluating VGX-3100 for the treatment of cervical dysplasia. We
designed this double blind, placebo controlled phase II study to
comprehensively measure efficacy, HPV viral clearance,
immunogenicity, and safety. At this time the data remains blinded.
We aim to report this data by the end of July.
With respect to efficacy, we are measuring regression of disease
from late stage cervical pre-cancer (CIN2/3) to early stage
pre-cancer (CIN 1) or elimination of disease. The study is 80%
powered to achieve a 52% response rate among vaccinated subjects
versus a hypothesized 25% in the placebo group. This 25% figure was
chosen based on response rates of natural regression that have
ranged widely between 4% and 40% in other studies.
We are hopeful that these results could lead to a novel
therapeutic option for women to avoid the invasive current surgical
procedure. There exists the prospect that our immunotherapy
approach may eliminate the presence of HPV virus to minimize future
recurrences.
What we are also measuring in all of these patients are T cell
responses. T cells are the vital agent of oncology immunotherapies.
This has been clearly validated by the recent advancements of
checkpoint inhibitor products, which have achieved admirable
results based on their ability to allow T cells to perform their
intended function (killing targeted cells), as well as in unrelated
CART technology products.
Overall, Inovio designed a technology platform to generate
antigen-specific T cells with the potential to eliminate cancers
and infectious diseases. T cell data from our phase I study of
VGX-3100, our DNA immunotherapy targeting pre-cancers and cancers
caused by HPV, showed that our SynCon® DNA-based immunotherapy
delivered with our CELLECTRA® device generated systemic T cell
responses with magnitude and durability exceeding other
technologies. We also measured and showed the killing effect of
these T cells against the targeted cells. No other technologies
have demonstrated T cell responses on par with Inovio's, including
those referenced in yesterday's article. These T cell results are
precisely why Inovio is executing its plans to expand Inovio's HPV
therapies to treat head and neck cancer (announced June 10th) and cervical cancer this
quarter. These T cell results also provide us confidence in
our plans to broadly go after other major cancers with our
proprietary immune therapy products INO-5150 for prostate cancer
(with Roche) and INO-1400 (breast, lung, and pancreatic cancers) in
2014.
Moreover, with this CIN 2/3 phase II study Inovio is in a
position to show for the first time how the level of T cells and
their specific functions in the body may be correlated to clinical
efficacy in an active immunotherapy setting using a large,
controlled study. The correlation between T cells and efficacy
could be instrumental in guiding Inovio's development path for its
technology, using different products and technology combinations to
target cancers and infectious diseases. As has been pointed out by
many astute investors and industry experts, the value of such T
cell immune data cannot be underestimated.
It was with hesitation that we have responded to inane
conjecture. However, we have received a substantial amount of
communication from stakeholders and wished to reiterate the facts
around our technology, products, and clinical study.
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, 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, 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.