Early Results from Ongoing Clinical Study of Hepatitis C Vaccine
Delivered by Inovio Biomedical’s
Electroporation System Show Increased T-Cell Responses and Reduced Viral
Loads
SAN DIEGO (Business Wire EON) June 30, 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
additional interim results from its ongoing phase I/II clinical study of
its ChronVac-C® therapeutic
DNA vaccine, which is delivered using Inovio’s
electroporation-based DNA delivery system. These preliminary results are
from the first two patients in the intermediate dose group to complete
treatment against hepatitis C virus infection. Samples taken before,
during and after treatment showed that the viral levels in blood
decreased up to 87% and 98%, respectively, during treatment.
Simultaneous activation of the patients’
T-cell responses to the hepatitis C virus was recorded in conjunction
with the viral load reductions. Inovio's electroporation delivery
technology is intended to enhance the potency of DNA vaccines against
cancers and infectious diseases.
ChronVac-C® is a
therapeutic 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. 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 three dose
groups with increasing doses of ChronVac-C. 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. If the patient is completely virus-free six months after
completing treatment, he/she will be considered cured.
In the group treated with the low dose of ChronVac-C, transient
activation of T-cell responses was recorded but no reduction of viral
load. In the group treated with the intermediate dose, T-cell responses
were recorded simultaneously with clear reductions in the serum levels
of hepatitis C virus, suggesting that the therapy is dose-dependent. No
severe adverse events have been recorded. All three patients in the high
dose group have started therapy and we expect results from this group
during the fall.
Avtar Dhillon, MD, Inovio's president and CEO, stated: “Recognizing
that this is still a very limited patient population and data set, we
are encouraged by the results of this hepatitis C virus phase I/II
clinical study. Existing treatments are hard on patients, often
described as being similar to chemotherapy, and are only effective in
roughly half of patients treated. We are pleased that to date this
therapy has not produced these chemotherapy-like side effects nor
serious adverse events and, without yet reaching the highest dose
levels, is producing positive results. The fact that there may be a
dose-dependent correlation between T-cell responses generated and
reduction in hepatitis C viral load may position ChronVac-C, in which we
have partial ownership, to potentially play a role as a first-line
therapy or as an adjunct to existing therapies. We look forward to the
continuing clinical assessment of this promising DNA vaccine candidate.”
The total market for therapies against hepatitis C infections was
estimated by Rodman & Renshaw to be around $3.5 billion in 2005 and to
grow to more than $8.0 billion in sales by 2012.
About Inovio Biomedical Corporation
Inovio Biomedical (AMEX:INO) is focused on developing multiple
DNA-based immunotherapies and DNA vaccines. Inovio is a leader
in developing human applications of electroporation using brief,
controlled electrical pulses to increase cellular uptake of a useful
biopharmaceutical. 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. 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 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 necessarily not 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, the actual size and
stability of the market(s) developed for our therapies, if any, 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 three months ended March 31,
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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