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Inovio Biomedical and Tripep Advance Pre-Clinical Development of DNA Vaccine for Hepatitis C

Posted on: Tuesday, 24 October 2006, 06:00 CDT

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 of Sweden, recently demonstrated that Tripep's proprietary DNA vaccine, ChronVac-C®, administered using Inovio's MedPulser® DNA Drug Delivery System activated a T-cell response in mice that appears capable of clearing liver cells expressing hepatitis C virus protein in a murine model of hepatitis C. In the current study a comparison with the gene gun delivery method also indicated that the MedPulser® gene delivery system performed as good as or better than the gene gun in inducing immune responses capable of clearing liver cells expressing hepatitis C virus proteins. These data complement the results of previous studies demonstrating that electroporation using the MedPulser® gene delivery system was as good as or better than the gene gun in inducing humoral immune responses in mice.

These data were obtained in support of a planned application for a clinical trial designed to test the therapeutic use of the combination of the ChronVac-C DNA vaccine and Inovio's MedPulser® gene delivery system in chronic hepatitis C infections. Tripep intends to conduct this phase I clinical study with healthy volunteers in Sweden in the first half of 2007.

About Inovio's DNA Delivery Technology

DNA vaccines have the potential to by-pass the numerous problems that plague conventional vaccines. For example, DNA vaccines may be better in stimulating cellular immunity necessary to fight chronic infection or diseases such as cancer. Despite this promise, vaccination using DNA plasmids alone, without enhanced delivery, has not been shown to reach the threshold for clinical benefit.

Intramuscular delivery of DNA vaccines using Inovio's proprietary electroporation technology has been shown in primate studies to boost the immune response by orders of magnitude over DNA plasmid alone. Plasmid-based vaccines induced higher levels of antibodies and T-cell responses when delivered via electroporation, suggesting the potential to provide better protection from infectious diseases such as HIV and hepatitis C.

About Hepatitis C and ChronVac-C

Hepatitis is a disease characterized by inflammation of the liver. Hepatitis C virus (HCV) is a major cause of acute hepatitis. HCV is spread primarily by direct contact with human blood, the major causes worldwide being the use of unscreened blood transfusions, and re-use of needles and syringes that have not been adequately sterilized. As many as 70% - 90% of newly infected patients may progress to develop chronic infection (WHO: 2002). Of those with chronic liver disease, 5% - 20% may develop cirrhosis. About 5% of infected persons may die from the consequences of long term infection (due to liver cancer or cirrhosis). Globally, an estimated 170 million people are chronically infected with HCV, which represents a reservoir sufficiently large for HCV to persist, and 3 to 4 million persons are newly infected each year. In the US, while new incidences of HCV have dropped dramatically, an estimated 4.1 million (1.6%) Americans have been infected with HCV, of whom 3.2 million are chronically infected (Centers for Disease Control and Prevention: 2006).

HCV infections in the liver do not trigger an immune response very effectively. Certain antiviral therapies, while expensive, are somewhat effective in treating hepatitis C, but there is no vaccine currently available to prevent hepatitis C. ChronVac-C® is designed to be a therapeutic DNA vaccine that can stimulate the body's immune system. Animal experiments have demonstrated that ChronVac-C vaccination activated B-cells and T-cells (the latter being regarded as the most significant to clearing the chronic infection relating to hepatitis C) that clear the liver of cells producing HCV protein. In humans, the ChronVac-C DNA plasmid would be injected into muscle tissue, where vaccinations are usually given, and taken up by muscle cells with the assistance of Inovio's electroporation-based DNA delivery system. These muscle cells would be expected to then produce predetermined proteins that may activate the body's immune system to attack all cells producing HCV proteins.

About Tripep AB

Tripep AB is a Swedish biotechnology research company that develops and commercialises candidate drugs based on patented and proprietary technologies. Its main focuses are research and clinical development of ChronVac-C®, a therapeutic vaccine against hepatitis C; clinical development on HGF to promote healing of chronic skin ulcers; preclinical development of prophylactic and therapeutic vaccines; and the RAS® technology platform. More information is available at www.tripep.se or contact Jan Nilsson, CEO at +46 8 449 8480 or jan.nilsson@tripep.se.

About Inovio Biomedical Corporation

Inovio Biomedical Corporation is a late stage biomedical company focused on a cancer ablation therapy and development of multiple DNA vaccines. Inovio is commercializing its proprietary Selective Electrochemical Tumor Ablation (SECTA) therapy and its delivery platform for gene-based treatments.

SECTA is designed for local treatment of solid tumors, with selective killing of cancer cells while preserving surrounding healthy tissue. Inovio is moving its lead product, the MedPulser®, 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 a Phase I trial for breast cancer.

Merck, Vical, University of Southampton and H. Lee Moffitt Cancer Center are conducting phase I clinical studies of novel gene-based therapies and DNA vaccines delivered using Inovio's electroporation-based technology. Innogenetics and Pharmexa are conducting DNA vaccine clinical studies using the company's recently acquired DNAvax® technology. Inovio is a leader in developing human therapeutic applications of electroporation and DNA vaccination, with the industry's most 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 the our Annual Report on Form 10-K for the year ended December 31, 2005, our Form 10-Q for the six months ended June 30, 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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