SAN DIEGO, June 7 /PRNewswire-FirstCall/ -- Vical Incorporated (Nasdaq: VICL - News) today announced that the National Institute of Allergy and Infectious Diseases (NIAID), after reviewing recently reported preclinical data from the company's avian influenza (flu) DNA vaccine program, has given the company accelerated access to $2.6 million in funding for further development of the vaccine under a grant awarded to Vical in September 2005. NIAID is part of the National Institutes of Health (NIH), an agency of the U.S. Department of Health and Human Services.
The funds will be used to complete preclinical development of the vaccine and file an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA), which would allow initiation of a Phase 1 safety trial in human volunteers. The company is seeking additional funding to support Phase 1 human testing.
The NIH provided notification that the data, which showed the Vaxfectin(TM)-formulated, three-component DNA vaccine provided complete protection of mice and ferrets against lethal challenges with the H5N1 avian influenza virus as well as protection of mice against multiple human flu strains, satisfied the second milestone (agreed to by the agency in 2005) under the two-year challenge grant. Remaining preclinical work includes safety, toxicology and biodistribution testing of the formulated vaccine in laboratory animals, as well as manufacturing of human clinical trial supplies in compliance with current Good Manufacturing Practice (GMP).
"One significant strength of our DNA technology is the speed with which we can develop a vaccine product concept, establish preclinical efficacy, and then advance to IND filing," said David C. Kaslow, M.D., Vical's Chief Scientific Officer. "Our Vaxfectin(TM)-formulated DNA flu vaccines have performed remarkably well in animal challenge studies, and this accelerated access to funding allows us to move forward ahead of our original schedule, which is quite important given the imminent threat posed by pandemic influenza."
Vical is collaborating on this program with St. Jude Children's Research Hospital, Memphis, Tenn., a world-renowned center of expertise in influenza research, including avian influenza. The goal is to design a vaccine that could be developed and manufactured quickly and safely, without handling the infectious organism, and stockpiled longer than conventional vaccines. The vaccine is expected to target both variable surface proteins and unchanging core proteins of the virus for protection against potential pandemic outbreaks characterized by highly virulent pathogens, rapid human-to-human disease transmission, and minimal prior immunity.
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 developed certain infectious disease vaccines and cancer therapeutics internally. 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.
This press release contains forward-looking statements subject to risks and uncertainties that could cause actual results to differ materially from those projected, including: whether the company will access any or all of the remaining $2.6 million available under the NIAID grant; whether the company will successfully complete preclinical development and file an IND; whether the company will secure additional funding to support Phase 1 human testing; whether the avian flu vaccine or any other product candidates will be shown to be safe and effective; the timing, nature and cost of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; whether the company's products will be developed and manufactured quickly and safely and stockpiled longer than conventional vaccines; whether Vical or its collaborative partners will succeed in marketing any product candidates; and additional risks set forth in the company's filings with the Securities and Exchange Commission. These forward-looking statements represent the company's judgment as of the date of this release. The company disclaims, however, any intent or obligation to update these forward-looking statements.
Contacts: Investors: Vical Incorporated
Alan R. Engbring
Media: Porter Novelli Life Sciences
Susan Neath Virginia Amann
(858) 527-3486 (608) 274-6046
Source: Vical Incorporated