Vical to Present Phase 1 Data for Vaxfectin-Formulated Pandemic Influenza DNA Vaccines
SAN DIEGO, July 14, 2008 /PRNewswire-FirstCall/ -- Vical Incorporated today announced the scheduled presentation of preliminary human safety and immunogenicity data from a Phase 1 trial of the company's Vaxfectin(R)-formulated H5N1 pandemic influenza DNA vaccines on Thursday, July 17, at the IBC Life Sciences Next Generation Vaccines conference (National Harbor, MD - July 17-18).
Vical's Vice President of Vaccine Research, Larry R. Smith, Ph.D., will present preliminary safety and immunogenicity results from this first human trial of vaccines formulated with the company's patented Vaxfectin(R) adjuvant. Results from this trial will drive the next steps in the company's H5N1 pandemic influenza vaccine program and could expand collaborative opportunities for both the Vaxfectin(R) adjuvant and the Vical DNA vaccine technology.
The double-blind, placebo-controlled, dose-escalation trial was conducted in approximately 100 healthy volunteers age 18 to 45 at three U.S. clinical sites. The trial was designed to assess safety and immunogenicity following intramuscular vaccination with needle and syringe or with the Biojector(R) 2000 needle-free injection system in different cohorts, and to evaluate monovalent and trivalent Vaxfectin(R)-formulated DNA vaccines at various doses.
Vical's monovalent vaccine contains a plasmid (a closed loop of DNA) encoding the hemagglutinin (HA) surface protein from the H5N1 influenza virus strain, A/Vietnam/1203/04. It is designed primarily to elicit antibody responses against the H5 protein, but could elicit T-cell responses against H5 as well. Vical's trivalent vaccine contains the H5 plasmid plus separate plasmids encoding consensus sequences of two highly-conserved influenza virus proteins: nucleoprotein (NP) and ion channel protein (M2). The trivalent vaccine is designed to elicit a combination of T-cell and antibody responses against all three proteins. Both vaccines are formulated with the company's Vaxfectin(R) adjuvant, which has demonstrated effectiveness with a variety of DNA vaccines in multiple animal models as well as dose-sparing and immune-enhancing ability in animals with a conventional seasonal influenza vaccine.
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 is developing 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 address significant unmet medical needs. Additional information on Vical is available at http://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. Forward-looking statements include statements about the next steps in the company's pandemic influenza vaccine program, the effect of the preliminary Phase 1 clinical trial results on the company's collaborative opportunities, and the design and potential benefits of the company's pandemic influenza vaccines. Risks and uncertainties include whether results from the Phase 1 trial will be favorable; whether Vical or others will continue development of the pandemic influenza vaccines or any other product candidates; whether results from the Phase 1 trial will determine next steps in the company's pandemic influenza vaccine program or expand collaborative opportunities for the Vaxfectin(R) adjuvant or the Vical DNA vaccine technology; whether any product candidates will be shown to be safe and efficacious in clinical trials; the timing of clinical trials; whether Vical or its collaborative partners will seek or gain approval to market any product candidates; the dependence of the company on its collaborative partners; 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: Alan R. Engbring Vical Incorporated (858) 646-1127 firstname.lastname@example.org Website: http://www.vical.com Media: Heidi Chokeir, Ph.D., or David Schull Russo Partners (619) 814-3512 email@example.com
CONTACT: investors, Alan R. Engbring of Vical Incorporated,+1-858-646-1127, ; or media, Heidi Chokeir, Ph.D.,, or David Schull, both of RussoPartners, +1-619-814-3512, for Vical Incorporated firstname.lastname@example.org email@example.com
Web site: http://www.vical.com/
Ticker Symbol: (NASDAQ-NMS:VICL)
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Posted: July 2008