02.03.2010 08:30:00
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Inovio Biomedical H5N1 Avian Influenza DNA Vaccine Receives Korean Approval to Begin Clinical Trials
Inovio Biomedical Corporation (NYSE Amex: INO), a leader in DNA vaccine design, development and delivery, announced today that its affiliate VGX International Inc. (Korean Stock Exchange: 011000) has received approval in Korea to begin a Phase I clinical trial in healthy volunteers for Inovio’s SynCon™ preventive DNA vaccine (VGX-3400) targeting H5N1 avian influenza. Inovio is co-developing VGX-3400 with Korea-based VGX International. The 30-patient three-dose Phase I study will be conducted in multiple clinical research sites in Korea. A parallel study in the U.S. is also planned for this year.
Dr. J. Joseph Kim, Inovio’s President and CEO, said, "Initiation of our H5N1 vaccine clinical trial marks an important milestone for our universal flu program. Inovio has been one of the first organizations to demonstrate a vaccine capable of providing protection against a broad set of unmatched influenza sub-types and strains, both seasonal and pandemic, in multiple animal models.”
"If we achieve similar results in human studies, this universal vaccine concept has the potential to shift the current reactive paradigm of influenza vaccine design, manufacturing, and delivery. Such a shift would provide tremendous health and economic benefits worldwide,” Dr. Kim added.
In pre-clinical studies, vaccination with VGX-3400 generated broadly protective levels of hemagglutination inhibition (HAI) titers in 100% of the immunized animals in five separate animal models - mice, ferrets, rabbits, pigs, and rhesus monkeys. Vaccination with VGX-3400 also protected animals from an unmatched, lethal H5N1 virus challenge in mouse, ferret, and monkey models. According to the World Health Organization, the H5N1 bird flu has infected 478 people in 15 countries since 2003 with 286 deaths (60% death rate). While H5N1 has never spread widely, one concern is the potential for the lethal H5N1 to "reassort” with another of the influenza sub-types that have been prone to spread more rapidly, possibly creating a more dangerous influenza strain.
About Inovio's SynCon™ Universal Influenza Vaccines
Inovio is focused on developing DNA-based influenza vaccines able to provide broad protection against known as well as newly emerging, unknown seasonal and pandemic influenza strains. Using its SynCon™ process, Inovio's scientists designed DNA vaccines targeting an optimal consensus of HA, NA, and NP proteins derived from multiple strains of the sub-types H1N1, H2N2, H3N2, and H5N1. These influenza sub-types have been responsible for the majority of seasonal and pandemic influenza outbreaks in humans.
Conventional vaccines are strain-specific and have limited ability to protect against genetic shifts in the influenza strains they target. They are therefore modified annually in anticipation of the next flu season's new strain(s). If a significantly different, unanticipated new strain emerges, such as the 2009 swine-origin pandemic strain, then the current vaccines provide little to no protective capability. In contrast, Inovio believes that its design approach to characterize a broad consensus of antigens across variant strains of each influenza sub-type creates the ability to protect against new strains that have common genetic roots, even though they are not perfectly matched. By formulating a single vaccine with some or all of the key sub-types, protection may be achieved against seasonal as well as pandemic strains such as swine flu or pandemic-potential strains such as avian influenza.
About Inovio Biomedical Corporation
Inovio Biomedical is focused on the design, development, and delivery of a new generation of vaccines, called DNA vaccines, to prevent and treat cancers and infectious diseases. The company’s SynCon™ technology enables the design of "universal” vaccines capable of protecting against multiple – including newly emergent, unknown – strains of pathogens such as influenza. Inovio’s proprietary electroporation-based DNA vaccine delivery technology has been shown by initial human data to safely and significantly increase gene expression and immune responses. Inovio’s clinical programs include HPV/cervical cancer (therapeutic) and HIV vaccines. An IND has been filed for an avian influenza vaccine. Inovio is developing its universal and avian influenza vaccines in collaboration with scientists from the University of Pennsylvania, the National Microbiology Laboratory of the Public Health Agency of Canada, and the NIH’s Vaccine Research Center. Other partners and collaborators include Merck, Tripep, University of Southampton, National Cancer Institute, and HIV Vaccines Trial Network. More information is available at www.inovio.com.
This press release contains, in addition to historical information, forward-looking statements. Such statements are based on management’s current estimates and expectations and are subject to a number of uncertainties and risks that could cause actual results to differ materially from those described in the forward-looking statements. Inovio is providing this information as of the date of this press release, and expressly disclaims any duty to update information contained in this press release.
Forward-looking statements in this press release include, without limitation, express and implied statements relating to Inovio’s business, plans to develop electroporation-based drug and gene delivery technologies and DNA vaccines and pre-clinical and clinical studies. Actual events or results may differ from the expectations set forth herein as a result of a number of risks, uncertainties and other factors, including but not limited to: Inovio has a history of losses; all of Inovio’s potential human products are in research and development phases; no revenues have been generated from the sale of any such products, nor are any such revenues expected for at least the next several years; Inovio’s product candidates will require significant additional research and development efforts, including extensive preclinical and clinical testing; uncertainties inherent in clinical trials and product development programs, including but not limited to the fact that pre-clinical and clinical results may not be indicative of results achievable in other trials or for other indications, that results from one study may not necessarily be reflected or supported by the results of other similar studies, that results from an animal study may not be indicative of results achievable in human studies, that clinical testing is expensive and can take many years to complete, that the outcome of any clinical trial is uncertain and failure can occur at any time during the clinical trial process, and that Inovio’s electroporation technology and DNA vaccines may fail to show the desired safety and efficacy traits in clinical trials; all product candidates that Inovio advances to clinical testing will require regulatory approval prior to commercial use, and will require significant costs for commercialization; the availability of funding; the ability to manufacture vaccine candidates; 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; whether Inovio’s proprietary rights are enforceable or defensible or infringe or allegedly infringe on rights of others or can withstand claims of invalidity; and the impact of government healthcare proposals. Readers are also referred to Inovio’s Annual Report on Form 10-K for the year ended December 31, 2008 and its Quarterly Report on Form 10-Q for the quarter ended September 30, 2009 filed with the Securities and Exchange Commission which identify important risk factors that could cause actual results to differ from those contained in the forward-looking statements.
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