BLUE BELL, Pa., Sept. 27, 2011 /PRNewswire/ -- Inovio Pharmaceuticals, Inc. (NYSE Amex: INO), a leader in the development of synthetic immunogens against cancers and infectious diseases, announced today that it has entered into a Cooperative Research and Development Agreement (CRADA) with the United States Department of Homeland Security (DHS) Science and Technology Directorate Plum Island Animal Disease Center. This collaboration will evaluate the efficacy of Inovio's SynCon® vaccines for foot & mouth disease (FMD) in important animal models including cattle, sheep, and pigs.
Inovio recently announced that it had designed and tested in animals a set of multi-subtype synthetic vaccine candidates for FMD clades A, O, C, and Asia. Following administration of these synthetic vaccines using Inovio's proprietary vaccine delivery technology in swine and sheep, all the vaccines induced strong antibody and T cell immune responses. Inovio's patented SynCon® vaccines cannot cause the targeted disease, providing a safe approach to potentially protect against FMD and reduce its serious impact on global food supply and commerce.
FMD is highly infectious and, due to the fear of inadvertent spread to farm animals, research with the live virus to test vaccine efficacy is heavily restricted in the US to only the Plum Island Animal Disease Center. Inovio's synthetic vaccines, by virtue of being non-live, non-replicating, and easily manufacturable, afford several potential advantages over other current vaccine approaches, including killed/attenuated virus vaccines and vectored vaccines. Under the CRADA, Inovio and DHS scientists will assess the potency of the vaccine candidates in neutralizing the infectivity of the virus and their efficacy in live virus challenge experiments.
Dr. J. Joseph Kim, Inovio's President and CEO, said: "FMD is the contagion posing the single greatest threat to the nation's food security. We are pleased to work with the Department of Homeland Security on this important security initiative and appreciate their support to advance novel, efficient and rapidly manufacturable methods to effectively and safely protect our national food supply."
About Foot-and-Mouth Disease
FMD virus is one of the most infectious agents causing significant disease in farm animals including cattle, swine, sheep and goats, and is capable of rapidly infecting large numbers of animals. Seven main types of FMD virus are believed to exist today. Like other viruses, the FMD virus continually evolves and mutates. To date there has been no cross-protection between serotypes.
While death rates are generally low, the highly infectious nature of the virus has a profound negative economic impact, such as in the dairy industry where cattle may experience reduced milk production, poor growth and permanent hoof damage. An FMD outbreak typically leads to economic sanctions, including the loss of export markets, and can negatively impact tourism as restrictions are placed on the movement of people and animals. In a major FMD outbreak in the UK in 2001, more than 4 million animals were slaughtered, resulting in more than $10 billion (USD) in economic losses. In a recent FMD epidemic in South Korea, 3.3 million swine were culled in an attempt to keep the disease from spreading.
About Inovio Pharmaceuticals, Inc.
Inovio is developing its revolutionary synthetic consensus immunogen technologies to extend the profound medical benefits of the 20th century's immune-system-stimulating vaccines by preventing and treating today's cancers and challenging infectious diseases. Its SynCon® vaccines are designed to provide universal cross-strain protection against known as well as newly emergent unmatched strains of pathogens such as influenza. These synthetic vaccines, in combination with Inovio's proprietary CELLECTRA® delivery method, have been shown in humans to be safe and generate best-in-class immune responses. Inovio's clinical programs include Phase II studies for cervical dysplasia/cancer, leukemia and hepatitis C virus and Phase I studies for influenza and HIV. Partners and collaborators include the University of Pennsylvania, Merck, ChronTech, National Cancer Institute, U.S. Military HIV Research Program, NIH, HIV Vaccines Trial Network, University of Southampton, 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 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, our ability to successfully integrate Inovio and VGX Pharmaceuticals, 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, 2010, our Form 10-Q for the three months ended June 30, 2011, 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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