Hepatitis C Therapeutic DNA Vaccine Delivered by Inovio Biomedical's
Electroporation Technology Reduces Viral Load by Up to 99.7%
Clinical Data Presented at Annual Scientific Meeting of the American
Association for the Study of Liver Diseases
SAN DIEGO (Business Wire EON/PRWEB ) November 17, 2008 --
Inovio
Biomedical Corporation (AMEX:INO), a
leader in enabling the development of DNA
vaccines using electroporation-based
DNA delivery, announced today that its partner, Tripep AB, reported
positive additional interim results from its ongoing phase I/II clinical
study of its therapeutic DNA vaccine against hepatitis C virus (HCV).
This vaccine is being delivered using Inovio’s
electroporation-based DNA delivery system. In the third and highest dose
cohort of the study, two of three subjects demonstrated reductions in
viral load of 93% and 99.7%. Previously reported middle dose cohort
results demonstrated an 87% and 98% reduction in HCV in two of three
subjects, while no anti-viral effect was observed in the low dose
cohort. No safety issues have been noted to date in the trial. These
data suggest a potential dose response of the vaccine and support the
inclusion of three additional subjects in the high dose cohort.
These data where presented by Dr. Matti Sällberg
of Tripep at the recent American Association for the Study of Liver
Diseases meeting held in San Francisco.
Avtar Dhillon, MD, Inovio's president and CEO, stated: “We
continue to be encouraged by the data flowing out of the ChronVac-C
study. This promising DNA vaccine candidate, in which Inovio has an
ownership position, is one of the more advanced clinical vaccine
candidates in the HCV field. ChronVac-C was designed to play a role as a
first-line therapy or as an adjunct to existing therapies.”
About ChronVac-C
ChronVac-C® is a
therapeutic DNA-based vaccine given to individuals already infected with
the hepatitis C virus with the aim of clearing the infection from the
liver by boosting the body’s immune response
against the virus. Inovio's electroporation technology is being used to
deliver the vaccine and is intended to enhance the potency of the DNA
vaccine. This clinical study is being conducted at the Infectious
Disease Clinic and Center for Gastroenterology at the Karolinska
University Hospital in Huddinge and Solna, respectively, in Sweden. The
intended enrollment of 12 patients is being divided into four groups,
three with increasing doses of ChronVac-C and the fourth at the maximum
tolerable dose. Each patient receives four vaccinations one month apart.
After the last vaccination, patients are followed for another six
months. The study's main purpose is to assess safety. It is also testing
whether the treatment boosts the immune response (immunogenicity) to HCV
and its effect on virus replication in the liver.
About Inovio Biomedical Corporation
Inovio Biomedical is focused on developing DNA vaccines for cancers and
infectious diseases using its novel method for DNA delivery –
electroporation – which uses brief, controlled
electrical pulses to increase cellular uptake of useful
biopharmaceuticals. Initial human data has shown that Inovio’s
electroporation-based DNA delivery technology can significantly increase
gene expression and immune responses from DNA vaccines. Immunotherapy
partners include Merck, Wyeth, Vical, University of Southampton, Moffitt
Cancer Center, the U.S. Army, National Cancer Institute, and
International Aids Vaccine Initiative. Inovio’s
technology is protected by an extensive patent portfolio covering in
vivo electroporation. The company has entered into a definitive
merger agreement with VGX Pharmaceuticals. More information is available
at www.inovio.com.
This press release contains certain forward-looking statements
relating to our plans to develop our electroporation drug and gene
delivery technology. Actual events or results may differ from our
expectations as a result of a number of factors, including the
uncertainties inherent in 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 and that
results from one study may not necessarily be reflected or supported by
the results of other similar studies), the availability of funding to
support continuing research and studies in an effort to prove safety and
efficacy of Inovio’s technology as a delivery
mechanism, the availability or potential availability of alternative
therapies or treatments for the conditions targeted by Inovio or its
collaborators, including alternatives that may be more efficacious or
cost-effective than any therapy or treatment that Inovio and its
collaborators hope to develop, evaluation of potential opportunities,
issues involving patents and whether they or licenses to them will
provide Inovio 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 Inovio can finance or devote
other significant resources that may be necessary to prosecute, protect
or defend them, the level of corporate expenditures, assessments of our
technology by potential corporate or other partners or collaborators,
capital market conditions, and other factors set forth in our Annual
Report on Form 10-K for the year ended December 31, 2007, our 10-Q for
the nine months ended September 30, 2008 and other regulatory filings
from time to time. There can be no assurance that any product in our
product 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 proved accurate.
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