HCV Viral Load Reduced in Phase I/II Trial
June 10, 2008
Reduced Hepatitis C Viral Level Achieved with DNA Vaccine Delivered by Inovio Biomedical’s Electroporation Delivery System in Phase I/II Clinical Study
June 4, 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, reported preliminary results indicating a dramatic reduction in hepatitis C viral load in its ongoing phase I/II clinical study of its ChronVac-C® therapeutic DNA vaccine, which is delivered using Inovio’s electroporation-based DNA delivery system. This result is from the first patient in the middle dose group to complete treatment against hepatitis C virus infection. Samples taken before, during and after treatment show that the viral levels in blood successively decreased by more than 95% during treatment. Inovio’s electroporation delivery technology is intended to enhance the potency of DNA vaccines against cancers and infectious diseases.
ChronVac-C® is a therapeutic vaccine given to individuals already infected with the hepatitis C virus with the aim to clear the infection by boosting the immune response against the virus. This clinical study is being conducted at the Infectious Disease Clinic and Center for Gastroenterology at the Karolinska University Hospital in Huddinge and Solna, respectively, in Sweden. The intended enrollment of 12 patients will be divided into three dose groups with increasing doses of ChronVac-C(R). Each patient receives four 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 (immunogenicity) 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.
In the lowest dose group, two patients who completed treatment developed a T-cell response to hepatitis C. The preliminary result from this first patient to complete treatment in the intermediate dose group is the first to indicate a significant reduction in viral load. There have been no severe adverse events.
“The benefit we would hope to see from a successful hepatitis C virus DNA vaccine would be a dramatic reduction in viral levels,” stated Avtar Dhillon, MD, Inovio’s president and CEO. “We look forward to seeing the longer term results of this DNA vaccine and its potential to address this multi-billion dollar market.”
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 using 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, our 10-Q for the three months ended March 31, 2008 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.
Inovio Biomedical Corporation
Bernie Hertel, 858-410-3101
Ronald Trahan Associates Inc.
Ron Trahan, 508-359-4005, x108
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