Vical Announces Marketing Approval of DNA Vaccine for Salmon
7/19/2005 7:00:36 AM
SAN DIEGO, July 19, 2005 /PRNewswire-FirstCall via COMTEX/ -- Vical Incorporated, (VICL) today announced that its licensee Aqua Health Ltd. of Canada, an affiliate of the Swiss-based company Novartis Animal Health, received notification of approval from the Canadian Food Inspection Agency (CFIA) to sell its proprietary product, APEX-IHN, a DNA vaccine to protect farm-raised salmon against Infectious Haematopoietic Necrosis Virus (IHNV). This vaccine has previously been available on a pre-approval basis in support of extensive field trials.
"This landmark approval is an important validation of Vical's underlying plasmid DNA delivery technology. This establishes safety and proof of efficacy in fish farming, a highly cost-sensitive commercial application," said Vijay B. Samant, Vical's President and Chief Executive Officer. "This success in advancing our plasmid DNA vaccine technology through the regulatory approval process in animals is another significant step in the development of human vaccines for targets such as cytomegalovirus, HIV, Ebola, West Nile virus, SARS and others."
About IHNV
IHNV is a virus that affects both multiple species of wild and farm-raised salmon. The disease is endemic in the Pacific North West in wild salmon populations, which has been a source of infection for farm-raised fish. Farm-raised Atlantic salmon are particularly susceptible when they are transferred to sea-water pens in the Pacific because they have no prior exposure. Outbreaks of IHNV can devastate a population of farm-raised salmon, with mortality rates up to 90 percent, and have caused serious economic losses for the industry since the disease was first noted in farm-raised salmon in the early 1990s.
About Vaccines
Vaccines to prevent infectious diseases are generally recognized as a more cost-effective approach than therapeutic intervention after disease has occurred. However, the technical limitations of conventional vaccine approaches have constrained the development of effective vaccines for many diseases. Conventional vaccines use dead or weakened live pathogens, or components of those pathogens, to produce an immune response. Among conventional vaccine technologies, only the weakened live pathogens can induce both T-cell and antibody immune responses, which are critical for prevention of certain diseases. All of these approaches require substantial development time, significant research and manufacturing infrastructure, and refrigerated shipping and storage.
Vical's technology uses closed loops of DNA, called plasmids, containing gene sequences encoding immunogenic features of a pathogen to induce an immune response against the pathogen. This method potentially offers effectiveness where other methods have failed, excellent safety, ease and reliability of manufacturing, as well as convenient storage and handling characteristics. In addition, the company's DNA delivery technology may accelerate certain aspects of vaccine product development. DNA vaccines have the ability to induce potent T-cell responses against target pathogens as well as to trigger production of antibodies. Over the past decade, many scientific publications have documented the effectiveness of DNA vaccines in generating immune responses in dozens of animal species.
About Vical
Vical researches and develops biopharmaceutical products based on its patented DNA delivery technologies for the prevention and treatment of serious or life-threatening diseases. Potential applications of the company's DNA delivery technology include DNA vaccines for infectious diseases or cancer, in which the expressed protein is an immunogen; cancer immunotherapeutics, in which the expressed protein is an immune system stimulant; and cardiovascular therapies, in which the expressed protein is an angiogenic growth factor. The company has retained all rights to its internally developed product candidates. In addition, the company collaborates with major pharmaceutical companies and biotechnology companies that give it access to complementary technologies or greater resources. These strategic partnerships provide the company with mutually beneficial opportunities to expand its product pipeline and serve significant unmet medical needs. Additional information on Vical is available at www.vical.com. |
