Inovio Biomedical Corporation (AMEX:INO), a leader in enabling the development of DNA vaccines using electroporation-based DNA delivery, announced that its partner, Tripep AB of Sweden, has begun enrolling patients for its Phase I/II clinical study of a novel DNA vaccine designed to treat chronically infected hepatitis C virus (HCV) patients. The trial will test Tripep's proprietary DNA vaccine, ChronVac-C®, administered using Inovio's MedPulser® DNA Delivery System, in 12 subjects already infected with HCV. The trial is being conducted in Sweden at the world-renowned Karolinska Institute.
The main purpose of the study is to show that the treatment is safe, but also to test if the treatment boosts patients' immune response to hepatitis C and its effects on virus replication. The market for therapies against hepatitis C infections is estimated at more than $2 billion and is expected to grow to more than $8 billion by 2015.
"This is the first human study in the world in which a DNA vaccine against an infectious disease is being administered by in vivo electroporation. We are enthusiastic that enrollment has started as planned," said Jan Nilsson, CEO of Tripep AB.
Dr. Avtar Dhillon, Inovio's president and CEO, said: "Inovio is pleased to reach this important clinical milestone. Because hepatitis C infections are responsible for a high incidence of debilitating liver disease and liver cancers each year, we are pleased the trial is moving forward rapidly. In addition, Tripep's hepatitis C DNA vaccine trial marks our fifth partnered clinical trial using Inovio's proprietary non-viral DNA delivery technology."
The study encompasses a total of 12 treatment naive patients with chronic hepatitis C virus infections of genotype 1 and with a low viral load. The patients will be divided into four dose groups. Each patient will receive four monthly vaccinations and then be monitored for another six months.
About Inovio's DNA Vaccine Technology
DNA vaccines 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 ability of Inovio's technologies to effectively deliver and significantly enhance the potency of such immunotherapies without the potential safety concerns of viral delivery systems.
Inovio's DNA-based immunotherapy products consist of DNA plasmids and electroporation-based DNA delivery systems. DNA plasmids are designed to express (produce) 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 induce a preventive or therapeutic immune response against the intended disease. Inovio's advanced electroporation devices facilitate delivery and expression of DNA vaccines to produce the desired antigens. Primate and/or interim Phase I data has have shown significantly enhanced antibody and T-cell immune responses relative to plasmid DNA delivered by other methods, suggesting the potential to provide better preventive or therapeutic effects against complex infectious diseases and cancers.
Inovio is poised to deliver advanced DNA-based vaccines and 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 Hepatitis C and ChronVac-C
Hepatitis is a disease characterized by inflammation of the liver. Hepatitis C virus (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 inadequately sterilized needles and syringes. 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, representing 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 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. There is no vaccine currently available to prevent hepatitis C. ChronVac-C(R) is designed to be a therapeutic DNA vaccine that can stimulate the body's immune system. Animal experiments 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 killed cells producing HCV protein. In humans, the ChronVac-C DNA plasmid will 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 antigens 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 commercializes candidate drugs based on patented and proprietary technologies. Its main focuses are research and clinical development of ChronVac-C(R), a therapeutic vaccine against hepatitis C; preclinical research focusing on the development of therapeutic and prophylactic vaccines against influenza A and HIV; and the RAS(R) technology platform.
tripep.se
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, using brief, controlled electrical pulses to increase cellular uptake of a useful biopharmaceutical. Interim human data has shown that Inovio's 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. 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 predominantly healthy tissue typically treated around a tumor. Inovio's technology is protected by an extensive patent portfolio covering in vivo electroporation.
inovio
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 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, 2006, our 10-Q for the six months ended June 30, 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.Inovio Biomedical Corporation