Early Results from Ongoing Clinical Study of Hepatitis C Vaccine Delivered by Inovio Biomedical's Electroporation System Show Increased T-Cell Responses and Reduced Viral Loads
SAN DIEGO--(BUSINESS WIRE)--Jun 30, 2008 - Inovio Biomedical Corporation), a leader in enabling the development of DNA vaccines using electroporation-based DNA delivery, announced today that its partner, Tripep AB, reported additional interim results from 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. These preliminary results are from the first two patients in the intermediate dose group to complete treatment against hepatitis C virus infection. Samples taken before, during and after treatment showed that the viral levels in blood decreased up to 87% and 98%, respectively, during treatment. Simultaneous activation of the patients' T-cell responses to the hepatitis C virus was recorded in conjunction with the viral load reductions. 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 of clearing the infection from the liver by boosting the body's 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 is being divided into three dose groups with increasing doses of ChronVac-C. 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 (immunogenicity) 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.
In the group treated with the low dose of ChronVac-C, transient activation of T-cell responses was recorded but no reduction of viral load. In the group treated with the intermediate dose, T-cell responses were recorded simultaneously with clear reductions in the serum levels of hepatitis C virus, suggesting that the therapy is dose-dependent. No severe adverse events have been recorded. All three patients in the high dose group have started therapy and we expect results from this group during the fall.
Avtar Dhillon, MD, Inovio's president and CEO, stated: "Recognizing that this is still a very limited patient population and data set, we are encouraged by the results of this hepatitis C virus phase I/II clinical study. Existing treatments are hard on patients, often described as being similar to chemotherapy, and are only effective in roughly half of patients treated. We are pleased that to date this therapy has not produced these chemotherapy-like side effects nor serious adverse events and, without yet reaching the highest dose levels, is producing positive results. The fact that there may be a dose-dependent correlation between T-cell responses generated and reduction in hepatitis C viral load may position ChronVac-C, in which we have partial ownership, to potentially play a role as a first-line therapy or as an adjunct to existing therapies. We look forward to the continuing clinical assessment of this promising DNA vaccine candidate."
The total market for therapies against hepatitis C infections was estimated by Rodman & Renshaw to be around $3.5 billion in 2005 and to grow to more than $8.0 billion in sales by 2012.
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, the actual size and stability of the market(s) developed for our therapies, if any, 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.
Bernie Hertel, 858-410-3101 (Investors)
Ronald Trahan Associates Inc.
Ron Trahan, 508-359-4005 ext. 108 (Media)
Posted: June 2008