Inovio: DNA delivery technology shows positive human results
Inovio Biomedical’s DNA Delivery Technology
Significantly Enhances Potency of Gene-Based Prostate Cancer
Vaccine
Key Milestone for First-in-Man DNA Vaccine Clinical Trial Using
Inovio’s Electroporation DNA Delivery Technology
SAN DIEGO, May 22, 2007 -- Inovio Biomedical Corp. (AMEX: INO),
focused on the development of DNA-based vaccines for cancers and
infectious diseases and a novel alternative to surgery to treat
localized cancers, announced today that interim data from a
clinical study of an experimental DNA-based prostate cancer vaccine
demonstrated that Inovio’s DNA delivery technology
significantly enhanced the potency of the gene-based vaccine.
Dr. Christian H. Ottensmeier, MD, PhD, Cancer Research UK Senior
Clinical Research Fellow at the University of Southampton, will
present interim data at the 3rd International Conference on DNA
Vaccines in Malaga, Spain, from this University of Southampton
Phase I/II clinical study of a prostate cancer vaccine, a
proprietary product owned by a third party, delivered by
Inovio’s electroporation technology. The results demonstrated
safety, tolerability and significantly higher antibody responses
for patients who received the vaccine with Inovio’s delivery
system versus those who were treated without it. Inovio’s
electroporation-mediated DNA delivery system is designed to enhance
the potency of DNA-based immunotherapies against cancers and
infectious diseases.
Inovio Biomedical has been collaborating with Dr. Ottensmeier since
2005 on this University of Southampton clinical study, titled
“A Phase I-II Trial of a DNA Vaccine with a PSMA27/pDOM
Fusion Gene Given by Intramuscular Injection in HLA2+ Patients with
Prostate Carcinomas with or without Electroporation.” This
study of patients with recurrent prostate cancer, approved by the
United Kingdom Medicines and Healthcare Products Regulatory Agency,
is assessing safety, tolerability, and cellular (T-cell) and
humoral (antibody) immune responses to a novel plasmid-based cancer
vaccine delivered using Inovio’s proprietary DNA delivery
technology. In each of the two arms of this study, i.e. with and
without electroporation-enhanced delivery, three patient groups are
being treated using escalating dosage levels. A total of 24
patients have been treated out of a total objective of 30
patients.
An analysis of interim data from the first and partially from the
second dose treatment groups demonstrated the following
points:
1. Electroporation appears safe and it is well tolerated.
2. The number of patients with significant antibody responses was
four of 10 in the patient groups treated without electroporation
compared to nine of 10 in the patient groups treated with
electroporation.
3. The magnitude of the antibody response was significantly higher
in patients treated using electroporation. Data on the T-cell
response is being compiled.
The investigators continue to enroll and treat patients in the
higher-dosage treatment groups.
“These data demonstrate for the first time in a clinical
trial that the significant enhancement in potency of a gene- based
vaccine delivered by electroporation in animals can also be seen in
humans,” said Dr. Christian Ottensmeier, clinical
investigator of the study.
“Achieving validation that the compelling pre-clinical data
generated by Inovio and partners in large animal models can be
achieved in humans is a key milestone for Inovio,” stated
Avtar Dhillon, MD, Inovio’s CEO. “These results suggest
that Inovio’s electroporation DNA delivery technology may
provide an important alternative to viral and other DNA delivery
technologies and could play a profound role in safely augmenting
the immune response generated by future prophylactic and
therapeutic immunotherapies against cancers and infectious diseases
such as HIV and hepatitis C,” added Dr. Dhillon.”
About Inovio’s Immunotherapy Products
DNA-based immunotherapy products have the potential to by-pass
inherent scientific obstacles of conventional vaccines that prevent
their development for cancer and chronic infectious diseases such
as HIV and hepatitis C. Pre-clinical data has indicated the
potential ability of Inovio’s technologies to safely and
effectively deliver and significantly enhance the potency of such
immunotherapies.
Inovio’s DNA-based immunotherapy products consist of DNA
plasmids and the Elgen and MedPulser DNA delivery systems. DNA
plasmids are designed to express antigens that can induce an immune
response specific to a cancer or infectious disease-causing
organism. These plasmids are created synthetically and readily
manufactured using well-established bacterial fermentation and
purification technology. After a plasmid is delivered into muscle
or tumor cells, production of the desired antigens may then induce
a preventive or therapeutic immune response against the targeted
disease. Inovio’s advanced electroporation devices facilitate
delivery and expression of such immunotherapies and have been shown
in primate studies to boost antibody and T-cell immune response by
orders of magnitude over DNA plasmid alone, suggesting the
potential to provide better protection from complex infectious
diseases such as HIV and hepatitis C as well as cancers such as
prostate and breast cancers.
Inovio is poised to deliver advanced DNA-based immunotherapies,
devices and know-how in this rapidly advancing field. The company
is actively licensing its technology to pharmaceutical and
biotechnology companies and supporting early stage clinical studies
arising from its own research efforts or through academic
collaborations.
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 5000 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 commercializing its Selective Electrochemical Tumor Ablation (SECTA) therapy. Inovio is a leader in developing human applications of electroporation, which uses brief, controlled electrical pulses to increase cellular uptake of a useful biopharmaceutical and, in the case of DNA-based treatments, levels of gene expression. Inovio’s DNA delivery partners include Merck, Wyeth, Vical, University of Southampton, Moffitt Cancer Center, and the U.S. Army, with four DNA-based immunotherapies in Phase I clinical studies. The SECTA therapy for locally treating solid tumors is designed to selectively kill cancerous cells and minimize cosmetic or functional detriments often caused by surgical removal of the predominantly healthy tissue typically treated around a tumor. The SECTA therapy is advancing through pre-marketing studies for head & neck and skin cancers in Europe, where it has CE Mark accreditation, a U.S. Phase III pivotal study for head and neck cancer, and a Phase I/II trial for breast cancer. 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 pre-clinical results referenced in this release may not be indicative of results achievable from testing in humans), 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, 2006, our Form 10-Q for the three months ending March 31, 2007, and other regulatory filings. There can be no assurance that any product in our product pipeline will be successfully developed or manufactured, or that final results of clinical studies will be supportive of regulatory approvals required to market licensed products.
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Posted: May 2007
