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Inovio's Presentations at Gene Therapy Meeting Showcase Potential for Electroporation in Delivering DNA Vaccines and Gene-Based Treatments of Protein-Deficiency Diseases.


SAN DIEGO San Diego (săn dēā`gō), city (1990 pop. 1,110,549), seat of San Diego co., S Calif., on San Diego Bay; inc. 1850. San Diego includes the unincorporated communities of La Jolla and Spring Valley. Coronado is across the bay.  -- Presentations Made Regarding Multiple Pre-Clinical Studies and First Human Trial Results Involving Inovio's Proprietary, Non-Viral DNA DNA: see nucleic acid.
DNA
 or deoxyribonucleic acid

One of two types of nucleic acid (the other is RNA); a complex organic compound found in all living cells and many viruses. It is the chemical substance of genes.
 Delivery Technology

Inovio Biomedical bi·o·med·i·cal
adj.
1. Of or relating to biomedicine.

2. Of, relating to, or involving biological, medical, and physical sciences.
 Corporation (AMEX AMEX

See: American Stock Exchange
:INO Ino (ī`nō), in Greek mythology, daughter of Cadmus. She was the wife of Athamas, to whom she bore Learchus and Melicertes. She plotted to kill her stepchildren, Phrixus and Helle, but their mother, Nephele, saved them with the help of a winged ) announced today that the focus on the company's technology at the American Society for Gene Therapy's (ASGT ASGT American Society of Gene Therapy
ASGT Adult Sergeant (UK Air Training Corps)
ASGT Auxiliary Steam Generator
) 9th Annual Meeting demonstrated the potential of electroporation electroporation (i·lekˈ·trō·p·rāˑ·sh  for delivering gene-based treatments in humans. Presentations relating to relating to relate prepconcernant

relating to relate prepbezüglich +gen, mit Bezug auf +acc 
 six pre-clinical studies and a pioneering clinical trial employing the company's MedPulser(R) DNA Electroporation System were made by Inovio representatives, Vical Incorporated (Nasdaq:VICL), and the University of South Florida


    [
 in conjunction with H. Lee Moffitt Cancer Center & Research Institute (Moffitt). In general, these studies indicated that the use of Inovio's non-viral electroporation technology to deliver therapeutic DNA demonstrated statistically significant levels of gene expression and immune response immune response
n.
An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes.
 in a safe and tolerable manner, indicating its promise as an alternative to viral and other non-viral DNA delivery methods.

The process of electroporation uses extremely short electrical field pulses to temporarily open cell membranes so that therapeutic DNA can enter target cells. Once inside the cells, this DNA may then elicit the production of proteins to stimulate an immune response or provide therapeutic gene expression. The presentations at the ASGT meeting featured results relating to the use of Inovio's technology for delivering different DNA vaccines and other gene-based therapeutics designed to treat cancer, infectious diseases infectious diseases: see communicable diseases. , and protein-deficiency diseases.

"Electroporation has demonstrated the ability to enhance immune responses to DNA vaccines," stated Vijay Samant, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board.  of Vical. "We continue to use Inovio's electroporation technology in our Phase 1 gene-based IL-2 trial for melanoma and are exploring its potential for other therapeutic DNA vaccine applications." Vical has an exclusive license to use Inovio's MedPulser(R) DNA Electroporation System for a DNA plasmid encoding IL-2 for melanoma, a non-exclusive license for DNA vaccines designed to treat HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States.  and CMV CMV cytomegalovirus.

CMV
abbr.
1. controlled mechanical ventilation

2. cytomegalovirus


Cytomegalovirus (CMV) 
, and an option to license the technology to deliver antigens relating to other infectious diseases.

"We were pleased to see our DNA electroporation technology broadly displayed at such an important scientific conference. Growing evidence shows that electroporation has the potential to enable or enhance the ability of DNA vaccines to generate clinically relevant immune responses and the ability of gene-based therapeutics to treat protein-deficiency diseases such as hemophilia. Highlighting positive results from a human study represents a milestone for Inovio and our proprietary delivery platform," said Avtar Dhillon, MD, president and CEO of Inovio. "Our goal is to establish electroporation as a preferred method of DNA delivery and to ensure Inovio's technology is a widely accepted method for commercializing DNA therapy."

The following is a summary of the presentations made by Inovio and collaborators at the ASGT meeting:
--  "Electroporation-Based Gene Therapy," part of a workshop,
        "Non-Viral Gene Therapy"

        Richard Heller, PhD, University of South Florida, professor of
        molecular medicine

        Interim results of a Moffitt-sponsored Phase I clinical trial
        delivering plasmid DNA encoding a cytokine, interleukin-12,
        into tumor cells to mount an immune response against malignant
        melanoma were presented by Dr. Heller, a co-researcher with
        Dr. Adil Daud, principal investigator of the study and an
        oncologist at Moffitt and the University of South Florida,
        College of Medicine. With 15 patients treated to date, results
        indicate that electroporation-mediated gene delivery was well
        tolerated, reproducible and without any dose limiting
        toxicity. The study showed efficient expression of IL-12 by
        the plasmid DNA, with demonstrable immune responses. Prior
        pre-clinical studies conducted by Heller and his team found
        that electroporation of IL-12 plasmid also resulted in IL-12
        expression in the tumor and an 80 percent complete regression
        of a very aggressive melanoma in a mouse model. Based on an
        assessment of international, peer-reviewed scientific
        publications, Inovio believes this is the first-ever study
        using electroporation to deliver a gene-based treatment in
        man.

    --  "Overview of Gene Vaccines"

        Alain P. Rolland, Pharm.D., Ph.D., Vical, senior vice
        president of product development

        --  A study in rabbits indicated that electroporation enhances
            the onset and magnitude of antibody production against an
            encoded cytomegalovirus (CMV) antigen in the company's CMV
            vaccine program.

        --  A study demonstrated that vaccination by DNA
            electroporation enhances anthrax lethal toxin neutralizing
            antibody production by several orders of magnitude.

        --  A study in rabbits indicated that plasmid DNA is cleared
            from injected muscles after intramuscular injection
            followed by electroporation and risk of integration into
            the host genome is negligible at 60 days.

    --  "Industrial Liaison: Clinical Developments in Gene Vaccines" -
        workshop

        Michael Fons, PhD, Inovio's executive director, corporate
        development

        Dr. Fons spoke about clinical electroporation and reviewed the
        pre-clinical and regulatory steps needed to begin clinical
        evaluation of plasmid delivery with Inovio's proprietary
        technology. Inovio is engaged in four phase I clinical studies
        conducted in conjunction with corporate and academic partners.
        Two phase I studies, with Vical, Inc. and the Moffitt Cancer
        Center are using immunotherapies against cancer. Two other
        clinical studies, with Merck and the University of Southampton
        are evaluating DNA vaccines against cancer.

    --  "Protection Against In Vivo Tumor Growth after
        Electroporation-Enhanced DNA Vaccination with the Hepatitis C
        Virus Non-Structural 3/4A" - poster presentation

        Rune Kjeken, Gustaf Ahlen, Jonas Soderholm, Torunn Tjelle,
        Iacob Mathiesen, and Matti Sallberg

        A study conducted with Tripep AB of Sweden indicated that
        electroporation enhanced cellular immune responses capable of
        eliminating HCV-antigen expressing cells. Results indicated
        that immunization without electroporation was ineffective. The
        company believes these results validate the concept of
        electroporation-augmented therapeutic vaccination against
        hepatitis C virus infections. The two companies are aiming to
        initiate a phase I clinical trial using this vaccine by the
        end of 2006.

    --  "DNA Vaccines: Induction of Humoral and Cellular Responses Via
        Skin or Muscle Immunization Enhanced by Electroporation" -
        poster presentation

        Lei Zhang, Georg Widera, Susan Bleecher, and Dietmar Rabussay

        This presentation summarized a study that demonstrated the
        capability of certain methods and devices, which are
        proprietary to Inovio, to elicit powerful immune responses
        with either skin or muscle as the target tissue. Immunization
        via skin electroporation can be performed non-invasively,
        which affords potential advantages over invasive muscle
        electroporation.

    --  "Feasibility of Cutaneous Gene Therapy Using a Factor VIII
        Gene and a Marker Gene in Factor VIII-Deficient Mice by
        Non-Invasive Electroporation" - poster presentation

        Lei Zhang, Amy Goldbeck, Hongbo Lu, Edward Nolan, Dietmar
        Rabussay, and Steve Fakharzadeh

        This presentation described a preclinical study conducted in
        collaboration with the University of Pennsylvania showing that
        injection of DNA encoding the blood clotting factor VIII
        (FVIII) into the skin of hemophilic mice gave rise to the
        expression of the FVIII gene. This confirms previous results
        indicating that electroporation-enhanced DNA delivery may be
        an attractive method of DNA delivery for the treatment of
        genetic diseases amenable to plasmid DNA-based gene therapy.


About the American Society of Gene Therapy American Society of Gene Therapy (ASGT) is a professional non-profit medical and scientific organization dedicated to:
  1. understanding, development and application of gene, related cell and nucleic acid therapies;


The ASGT is a professional non-profit medical and scientific organization dedicated to the understanding, development and application of gene and related cell and nucleic acid nucleic acid, any of a group of organic substances found in the chromosomes of living cells and viruses that play a central role in the storage and replication of hereditary information and in the expression of this information through protein synthesis.  therapies and the promotion of professional and public education in the field. ASGT is the largest medical professional organization representing researchers and scientists dedicated to discovering new gene therapies.

About Vical

Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system immune system

Cells, cell products, organs, and structures of the body involved in the detection and destruction of foreign invaders, such as bacteria, viruses, and cancer cells. Immunity is based on the system's ability to launch a defense against such invaders.
 stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic angiogenic /an·gio·gen·ic/ (-jen´ik)
1. pertaining to angiogenesis.

2. of vascular origin.

angiogenic adjective Relating to angiogenesis
 growth factor. The company has developed certain infectious disease Infectious disease

A pathological condition spread among biological species. Infectious diseases, although varied in their effects, are always associated with viruses, bacteria, fungi, protozoa, multicellular parasites and aberrant proteins known as prions.
 vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies Top 100 Biotechnology Companies
The following is a list of the top 100 biotechnology companies ranked by revenue. The first nine companies qualify for the list of the top 50 pharmaceutical companies.
 that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial Adj. 1. mutually beneficial - mutually dependent
interdependent, mutualist

dependent - relying on or requiring a person or thing for support, supply, or what is needed; "dependent children"; "dependent on moisture"
 opportunities to expand its product pipeline and serve significant unmet medical needs. Additional information on Vical is available at www.vical.com.

About University of South Florida

The University of South Florida is one of the nation's top 63 public research universities as designated by the Carnegie Foundation
This article is about the Dutch Carnegie Foundation, owner and manager of the Peace Palace. For other uses, see The Carnegie Foundation.


The Carnegie Foundation ("Carnegie Stichting" in Dutch) is an organization based in The Hague, The Netherlands.
 for the Advancement of Teaching. USF USF University of South Florida
USF Universal Service Fund (often part of phone bill in US)
USF University of San Francisco
USF University of Sioux Falls
USF University of St.
 received more than $287 million in research contracts and grants last year, and it is ranked by the National Science Foundation as one of the nation's fastest growing universities in terms of federal research and development expenditures. The university has a $1.3 billion annual budget and serves nearly 43,250 students on campuses in Tampa, St. Petersburg, Sarasota/Manatee and Lakeland. USF is a member of the Big East athletic conference An athletic conference is a collection of sports teams, playing competitively against each other at the collegiate or high school level. In many cases conferences are subdivided into smaller and smaller divisions, with the best teams competing at successively higher levels. .

About Inovio Biomedical Corporation

Inovio Biomedical Corporation is a late stage biomedical company focused on commercializing its proprietary Selective Electrochemical electrochemical /elec·tro·chem·i·cal/ (-kem´i-k'l) pertaining to interaction or interconversion of chemical and electrical energies.

e·lec·tro·chem·i·cal
adj.
 Tumor Ablation (SECTA) therapy. SECTA is designed to target a significant unmet clinical need: a local treatment for solid tumors, with selective killing of cancer cells cells once believed to be peculiar to cancers, but now know to be epithelial cells differing in no respect from those found elsewhere in the body, and distinguished only by peculiarity of location and grouping.

See also: Cancer
 while preserving surrounding healthy tissue. Inovio is moving its lead product, the MedPulser(R), through pre-marketing studies for head and neck cancer and skin cancers in Europe, where it has CE Mark accreditation, a U.S. Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA  pivotal study for head and neck cancer, and Phase I trials for pancreatic and breast cancer. Merck, Vical, University of Southampton In the most recent RAE assessment (2001), it has the only engineering faculty in the country to receive the highest rating (5*) across all disciplines.[3] According to The Times Higher Education Supplement , and H. Lee Moffitt Cancer Center are using Inovio's gene delivery technology in clinical studies of novel DNA therapeutics delivered using electroporation. Inovio is a leader in developing human therapeutic applications of electroporation, with the industry's most extensive patent portfolio covering in vivo in vivo /in vi·vo/ (ve´vo) [L.] within the living body.

in vi·vo
adj.
Within a living organism.



in vivo adv.
 electroporation. More information is available at www.inovio.com.

Based on the award of a procurement contract to a third party for a second-generation anthrax vaccine, the grant of Emergency Use Authorization for the first-generation anthrax vaccine, and discussions with government agencies, it appears that funding needed to support further clinical development of Vicals third-generation anthrax vaccine will not be available in the forseeable future. Therefore, Vical does not intend to pursue further development of its anthrax vaccine candidate at this time.

This press release contains certain forward-looking statements relating to our plans to develop our electroporation drug and gene delivery technology and maximize shareholder value. 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 results from pre-clinical studies referenced in this release may not be indicative of results achievable in human studies; interim results from the Phase I study referenced in this release may vary significantly from final results of this and other ongoing clinical studies and referenced preclinical results involving a small number of mice may not be indicative of results achievable from testing in humans; whether Vical or others will continue development of the CMV vaccine; and whether the CMV vaccine would be shown to be safe and effective), evaluation of potential opportunities, level of corporate expenditures, assessment of our technology by potential corporate partners, capital market conditions, and other factors set forth in the our Annual Report on Form 10-K Form 10-K

A report required by the SEC from exchange-listed companies that provides for annual disclosure of certain financial information.


Form 10-K

See 10-K.
 for the year ended December 31, 2005, our Form 10-Q Form 10-Q

See 10-Q.
 for the three months ended March 31, 2006, 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.
COPYRIGHT 2006 Business Wire
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 2006, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Publication:Business Wire
Geographic Code:1USA
Date:Jun 6, 2006
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