BLUE BELL, Pa., Oct. 21, 2013 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE MKT: INO) announced today that the safety, tolerability and immunogenicity of its therapeutic vaccine for hepatitis C (INO-8000/VGX-6150) will be studied in a phase I clinical trial in chronically HCV infected patients. Under a 2011 collaborative development agreement, Inovio's affiliate, VGX International Inc. (KSE: 011000), is fully funding and conducting the study at multiple sites in Korea. Inovio is also planning to evaluate this hepatitis C (HCV) vaccine in additional clinical studies in the U.S. beginning in 2014.
Dr. J. Joseph Kim, Inovio's President and CEO, said, "More effective antiviral drugs have changed the prognosis for patients with hepatitis C; however, treatment failures remain and combination with an immunotherapeutic approach could make the difference for many patients. In preclinical studies, Inovio's HCV immunotherapy has shown to generate powerful T cell responses in the liver, which could be important in clearing HCV-infected liver cells. We have already shown in published clinical studies that our vaccines generate best-in-class T-cell responses. In this study, the effects of Inovio's HCV immunotherapy will be directly tested in patients who have previously failed standard drug therapies. We look forward to entering the hepatitis C treatment arena, which is one of the fastest-developing markets in healthcare, with a projected value of $20 billion by the end of the decade."
This study is a multi-center, open-label, dose-escalating phase I trial in which 18 subjects will be divided into three groups and given four monthly vaccinations of 1 mg, 3 mg and 6 mg doses of VGX-6150, respectively. Individuals with chronic HCV who failed previous standard of care therapy with pegylated interferon and ribavirin or triple therapy with standard of care and direct-acting antiviral agents such as boceprevir or telaprevir will be enrolled. Both immunogenicity and virologic response will be evaluated in addition to the safety and tolerability of VGX-6150.
VGX-6150 is a SynCon® multi-antigen DNA vaccine covering hepatitis C virus (HCV) genotypes 1a and 1b and targeting HCV nonstructural proteins 3 (NS3) and 4A (NS4A) as well as NS4B and NS5A proteins. VGX-6150 also includes DNA encoding IL-28B to adjuvant the immune response. VGX-6150 will be administered with Inovio's proprietary CELLECTRA® delivery device.
About Hepatitis C
Hepatitis C is a contagious liver disease that ranges in severity from a mild illness lasting a few weeks to a serious, lifelong illness that attacks the liver. It results from infection with the hepatitis C virus (HCV), which is spread primarily through contact with the blood of an infected person. Hepatitis C can be either "acute" or "chronic." Acute hepatitis C virus infection is a short-term illness that occurs within the first six months after someone is exposed to the virus. For most people, acute infection leads to chronic infection, which can last a lifetime and lead to serious liver problems including cirrhosis (scarring of the liver) or liver cancer.
Currently there is no vaccine available for the prevention of hepatitis C infection. HCV mutation contributes to the difficulty in development of a prophylactic vaccine. The World Health Organization estimates that nearly 200 million people around the world are infected with hepatitis C, a prevalence of around 3.3% of the world's population. As many people are infected with HCV as are with HIV, the virus that causes AIDS. Without large scale efforts to contain the spread of HCV and treat infected populations, the death rate from hepatitis C will surpass that of AIDS in this century.
Inovio's SynCon® DNA vaccine, INO-8000, is coded to produce the antigens NS3/4A, NS4B, and NS5A of HCV genotypes 1a and 1b, the most difficult-to-treat genotypes. This broad spectrum of antigens targets HCV to create a higher probability to induce the desired therapeutic immune response. Our proprietary DNA vaccines are uniquely designed to enhance gene expression and antigen secretion, processing, and presentation through a proprietary combination of DNA, RNA, and codon optimization techniques as well as the use of patent protected IgE leader sequences. Our novel SynCon design is intended to provide broader protection against new mutations of a virus. Our CELLECTRA® electroporation device co-localizes vaccine delivery with the applied electric field and operates under more effective constant-current EP parameters. Together these next-generation technologies have generated levels of T-cells that are often orders of magnitude greater than competing technologies, including those using viral vectors and other facilitated delivery systems.
Under a co-development agreement signed between Inovio and VGX International in 2011, VGX International is funding the studies in Asia and has the commercialization right for the product (also known as VGX-6150) in Asia (excluding Japan).
About Inovio Pharmaceuticals, Inc.
Inovio is revolutionizing vaccines to prevent and treat today's cancers and challenging infectious diseases. Its SynCon® vaccines, in combination with its proprietary electroporation delivery, are generating best-in-class immune responses, with therapeutic T-cell responses exceeding other technologies in terms of magnitude, breadth, and response rate. Human data to date have shown a favorable safety profile. Inovio's lead vaccine, a therapeutic against HPV-caused pre-cancers and cancers, is in phase II. Other phase I and preclinical programs target prostate, breast, and lung cancers as well as HIV, influenza, malaria and hepatitis. Partners and collaborators include Roche, the University of Pennsylvania, Merck, NIH, HIV Vaccines Trial Network, National Cancer Institute, U.S. Military HIV Research Program, University of Southampton, US Dept. of Homeland Security, University of Manitoba and PATH Malaria Vaccine Initiative. More information is available at www.inovio.com.
This press release contains certain forward-looking statements relating to our business, including our plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines and our capital resources. Actual events or results may differ from the expectations set forth herein as a result of a number of factors, including uncertainties inherent in pre-clinical studies, clinical trials and product development programs (including, but not limited to, the fact that pre-clinical and clinical results referenced in this release may not be indicative of results achievable in other trials or for other indications, that the studies or trials may not be successful or achieve the results desired, that pre-clinical studies and clinical trials may not commence or be completed in the time periods anticipated, that results from one study may not necessarily be reflected or supported by the results of other similar studies and that results from an animal study may not be indicative of results achievable in human studies), the availability of funding to support continuing research and studies in an effort to prove safety and efficacy of electroporation technology as a delivery mechanism or develop viable DNA vaccines, the adequacy of our capital resources, the availability or potential availability of alternative therapies or treatments for the conditions targeted by the company or its collaborators, including alternatives that may be more efficacious or cost-effective than any therapy or treatment that the company and its collaborators hope to develop, evaluation of potential opportunities, issues involving product liability, issues involving patents and whether they or licenses to them will provide the company 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 the company can finance or devote other significant resources that may be necessary to prosecute, protect or defend them, the level of corporate expenditures, assessments of the company's technology by potential corporate or other partners or collaborators, capital market conditions, the impact of government healthcare proposals and other factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2012, our Form 10-Q for the quarter ended June 30, 2013, and other regulatory filings from time to time. There can be no assurance that any product in Inovio's 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 proven accurate.
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