Fw: NATAP: Hepatitis C Vaccine Phase I Clinical Study
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Inovio Biomedical Partner Tripep Files Application for Phase I Clinical Study of Hepatitis C DNA Vaccine
SAN DIEGO--(BUSINESS WIRE)--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, has filed an application for a phase I clinical study with the Swedish Medical Products Agency. The application is designed to permit initial clinical testing of Tripep's proprietary DNA vaccine, ChronVac-CÂ®, administered using Inovio's MedPulserÂ® DNA Delivery System. This combination is designed to activate a T-cell response capable of clearing hepatitis C virus. Tripep intends to conduct a phase I clinical study in healthy volunteers at the Center for Gastroenterology at Karolinska University Hospital in Sweden beginning in early 2007.
â?oOur partnership with Tripep has rapidly moved this vaccine from concept to initial clinical evaluation in less than a year,â? stated Avtar Dhillon, MD, Inovio's president and CEO. â?oThis vaccine trial represents the first study in man of an infectious disease vaccine delivered with electroporation and we are excited about the product's potential.â?
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(R) 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 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 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 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. More information is available at www.tripep.se. Contact Jan Nilsson, CEO, at +46 8 449 8480 or jan.nilsson@....
About Inovio Biomedical Corporation
Inovio Biomedical Corporation is a late stage biomedical company focused on commercializing its proprietary Selective Electrochemical Tumor Ablation (SECTA) therapy and development of multiple DNA vaccines using 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 MedPulserÂ®, 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. Inovio's DNA delivery partners include Merck, Wyeth, Vical, Tripep, University of Southampton, H. Lee Moffitt Cancer Center, U.S. Army, Innogenetics and Pharmexa, with six gene-based therapies and DNA vaccines in phase I clinical studies. 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 our Annual Report on Form 10-K for the year ended December 31, 2005, our Form 10-Q for the nine months ended September 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.
Inovio Biomedical Corporation
Bernie Hertel, 858-410-3101 (Investor Relations)
Porter Novelli Life Sciences
Susan Neath, 619-849-6007 (Media Relations)
At A Glance
Inovio Biomedical Corporation
Headquarters: San Diego, California
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