Therapeutic Hepatitis C Vaccine Gets Its First Human Safety Marks
March 20, 2008
Hepatitis C Virus DNA Vaccine Shows Safety When Delivered by Inovio Biomedical’s Electroporation Delivery System in Phase I/II Clinical Study at Karolinska University Hospital
March 17, 2008
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 reported preliminary results from the first patient to complete treatment with Tripep’s therapeutic hepatitis C virus (HCV) vaccine, ChronVac-C®, which was delivered using Inovio’s electroporation-based DNA delivery system. In this phase I/II clinical study, the treatment has so far been safe and tolerable. Samples taken before, during and after treatment showed that before vaccination the patient did not have a detectable cell-mediated immune response against HCV but such an immune response became detectable after treatment was completed. Inovio’s electroporation delivery technology is intended to enhance the potency of DNA-based immunotherapies, including DNA vaccines, against cancers and infectious diseases.
ChronVac-C® is a therapeutic DNA vaccine being given to individuals already infected with hepatitis C virus with the aim to clear the infection by boosting a cell-mediated immune response against the virus. It is known that patients who spontaneously clear their infection have also developed this type of immune response.
This clinical study is being conducted at the Infectious Disease Clinic and Center for Gastroenterology at the Karolinska University Hospital in Huddinge and Solna (Sweden), respectively. Intended enrollment is 12 patients divided into three dose groups with increasing doses of ChronVac-C®. Each patient receives four ChronVac-C® vaccinations one month apart. After the last vaccination, patients are followed for another six months. The study’s main purpose is to assess safety. It is also testing whether the treatment boosts the immune response to HCV and its effect on virus replication in the liver. If the patient is completely virus-free six months after completing treatment, he/she will be considered cured. This first reported data was from the first patient in the lowest dose group. Five patients have been treated and no unexpected side effects have been observed.
“We are pleased that this first infectious disease DNA vaccine to be delivered in humans using electroporation-based DNA delivery has provided initial evidence of being safe and inducing a cell mediated immune response against the hepatitis C virus,” stated Avtar Dhillon, MD, Inovio’s president and CEO. “We look forward to seeing additional data, particularly from the higher dose groups, relating to this potential treatment to a pervasive and difficult-to-treat disease.”
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). The total market for therapies against hepatitis C infections is estimated to be over 2 billion dollars and is expected to grow to more than 8 billion dollars by 2015.
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 a therapeutic DNA vaccine designed with the aim of stimulating 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 is being 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 are expected to 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. More information is at www.tripep.se. Contact Jan Nilsson, CEO, at +46 8 449 8480 or [email protected]
About Inovio Biomedical Corporation
Inovio Biomedical (AMEX:INO) is focused on developing multiple DNA-based immunotherapies and DNA vaccines. Inovio is a leader in developing human applications of electroporation which uses brief, controlled electrical pulses to increase cellular uptake of a useful biopharmaceutical. Human data has shown that Inovio’s electroporation-based 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. Inovio’s technology is protected by an 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 clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications 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, 2007, and other regulatory filings from time to time. There can be no assurance that any product in our product pipeline will be successfully developed or manufactured, that final results of clinical studies will be supportive of regulatory approvals required to market licensed products, or that any of the forward-looking information provided herein will be proved accurate.
Bernie Hertel, 858-410-3101 (Investors)
Ronald Trahan Associates Inc.
Ron Trahan, 508-359-4005 ext. 108 (Media)
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