05.06.2008 10:00:00
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Inovio Biomedical Provides Updated Interim Data on Phase I/II Clinical Study of Electroporation-Delivered Prostate Cancer DNA Vaccine at ASGT Annual Meeting
Inovio
Biomedical Corporation (AMEX:INO), a
leader in enabling the development of DNA
vaccines using electroporation-based
DNA delivery, announced today that Dr. Christian H. Ottensmeier, MD,
PhD, Cancer Research UK Senior Clinical Research Fellow at the
University of Southampton, presented updated interim data from a
clinical study of an experimental DNA-based prostate cancer vaccine at
the American Society of Gene Therapy 11th Annual
meeting in Boston, May 28 – June 1. The data
reaffirms that, post-treatment, this therapy has proven to be safe and
well-tolerated. Additional testing has further validated higher levels
of antibody and anti-DOM CD4 responses achieved in patients treated
using electroporation.
This academic study is a phase I/II study of 30 HLA A2+ patients with
biochemical failure of prostate cancer. The study is testing a DNA
fusion vaccine, developed in Southampton, encoding for an
immunostimulant sequence from tetanus linked to a sequence from prostate
specific membrane antigen (PSMA27). The study is
also evaluating electroporation as a novel delivery strategy for DNA
vaccines compared to DNA delivered without electroporation.
Patient enrollment for this study has been completed. Monitoring of
antibody responses was completed for the 20 patients at the first and
second dose levels. Monitoring of CD4 cellular immunity has been
completed for the 10 patients at the lowest dose. These 10 patients have
additionally been assessed for CD8 T-cell responses. Interim results to
date include:
Vaccination with and without electroporation has been safe and
well-tolerated.
14 of 20 patients developed increases in anti-DOM (the immunostimulant
sequence from tetanus) antibody. Of these increased responses, 5 of 10
were in the arm not using electroporation; 9 of 10 were in the
electroporation arm. Antibody responses were generally higher in
patients treated using electroporation compared to those treated with
the DNA vaccine alone (without electroporation).
In 9 of 10 patients in the low dose cohort, significant increases in
CD4 responses were observed relative to pre-treatment. Of these
increased responses, 4 of 5 were in the electroporation arm. Patients
treated exclusively with electroporation produced a higher average CD4
response; patients initially treated without electroporation and later
receiving a boost in conjunction with electroporation also displayed
increased CD4 responses following the electroporation boost.
In the low dose cohort, the PSMA27 antigen
induced CD8+ cytotoxic T-cells (measured by
cultured IFNg ELISPOT) not detected before vaccination in 6 of 10
subjects.
Avtar Dhillon, MD, president and CEO of Inovio, said: "We
are pleased that this phase I/II clinical study not only established the
tolerability of this therapy against prostate cancer but that over time
it is continuing to validate the safety of a DNA vaccine delivered using
our electroporation DNA vaccine delivery technology. Also important is
the heightened immune response achieved using electroporation compared
to injection of the DNA vaccine without electroporation.”
To listen to an online interview with Dr. Christian Ottensmeier, please
click here. Dr.
Ottensmeier discusses the use of electroporation to enhance the potency
and delivery of DNA vaccines.
About the University of Southampton
The University of Southampton is a leading UK teaching and research
institution with a global reputation for leading-edge research and
scholarship. It is one of the UK’s top 10
research universities, offering first-rate opportunities and facilities
for study and research across a wide range of subjects in humanities,
health, science and engineering. The University has around 20,000
students and over 5,000 staff. Its annual turnover is in the region of £310
million. www.soton.ac.uk 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, 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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