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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

Posted on: Tuesday, 6 June 2006, 06:00 CDT

Presentations Made Regarding Multiple Pre-Clinical Studies and First

Human Trial Results Involving Inovio's Proprietary, Non-Viral DNA

Delivery Technology

Inovio Biomedical Corporation (AMEX:INO) announced today that the focus on the company's technology at the American Society for Gene Therapy's (ASGT) 9th Annual Meeting demonstrated the potential of electroporation for delivering gene-based treatments in humans. Presentations relating to 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 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, and protein-deficiency diseases.

"Electroporation has demonstrated the ability to enhance immune responses to DNA vaccines," stated Vijay Samant, president and CEO 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 and 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

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 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 stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company has developed certain infectious disease vaccines and cancer therapeutics internally. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial 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 for the Advancement of Teaching. USF 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.

About Inovio Biomedical Corporation

Inovio Biomedical Corporation is a late stage biomedical company focused on commercializing its proprietary Selective Electrochemical 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 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 pivotal study for head and neck cancer, and Phase I trials for pancreatic and breast cancer. Merck, Vical, University of Southampton, 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 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 for the year ended December 31, 2005, our Form 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.

Source: Business Wire

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