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Vical's proprietary core technology is based on plasmid DNA (pDNA), closed loops of DNA that encode any protein of interest. When injected into tissues such as skeletal muscle or the skin, cells take up pDNA and produce the encoded protein. This allows for pDNA to be used as the basis for a broad range of biopharmaceutical products: infectious disease vaccines (delivering antigens from viruses, bacteria, or parasites), cancer vaccines or immunotherapeutics (delivering tumor antigens or immunostimulatory proteins), and growth factors to stimulate angiogenesis and tissue repair in diseases such as cardiovascular disorders.
Since its initial discovery, Vical has continued to improve its DNA delivery technology so as to maximize gene expression as well as the body's response to the proteins produced. For example, we optimize the DNA sequences that make up our pDNA, and we continue to develop new formulation and delivery technologies, including the use of lipid molecules (which can function as vaccine adjuvants) and synthetic polymers such as poloxamers.
Plasmids are manufactured in Vical's cGMP facility in San Diego using uniform methods of bacterial fermentation and processing, which allows faster development and production times than technologies that require development of product-specific processes. In addition, since our product candidates contain no viral components they are designed to avoid unwanted immune responses, infections, or malignant changes in a cell's genetic makeup, and have been administered repeatedly with a very favorable safety profile in clinical trials to date.
http://www.vical.com/technology/vaxfectin/default.aspx
http://www.vical.com/technology/publications/default.aspx
Vical has filed thirteen investigational new drug applications to conduct clinical trials and holds four master files for manufacturing recombinant DNA products.
Vical has completed more than thirty clinical trials with recombinant DNA products. These Phase 1 – Phase 3 trials of vaccines or gene therapy products have been conducted in up to 15 countries.
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Phase 3 Clinical Trial: ASP0113 Therapeutic Cytomegalovirus (CMV) Vaccine
A Study to Evaluate a Therapeutic Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seropositive Recipients Undergoing Allogeneic, Hematopoietic Cell Transplant (HCT). For more information, please go to the NCT01877655 trial listing at ClinicalTrials.gov.
Phase 2 Clinical Trial: ASP0113 Therapeutic Cytomegalovirus (CMV) Vaccine 1
A Study to Evaluate the Efficacy and Safety of a Vaccine, ASP0113, in Cytomegalovirus (CMV)-Seronegative Kidney Transplant Recipients Receiving an Organ From a CMV-Seropositive Donor. For more information, please go to the NCT01974206 trial listing at ClinicalTrials.gov.
Phase 1/2 Clinical Trial: Safety and Efficacy Trial of DNA Vaccines to Treat Genital Herpes in Adults
A Randomized, Double-Blind, Placebo-Controlled, Dose-Escalation, Phase 1/2 Trial to Evaluate the Safety and Efficacy of Herpes Simplex Virus, Type 2 Therapeutic DNA Vaccines in Symptomatic HSV-2-Seropositive Adults. For more information, please go to the NCT02030301 trial listing at ClinicalTrials.gov. ?
$VICL recent news/filings
Many thanks to stocktrademan for post #774
