Vical Completes Final Patient Follow-Up in TransVax(TM) CMV Vaccine Phase 2 Trial
- Category: Vaccines
- Published on Monday, 23 November 2009 02:00
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Vical Incorporated announced that the company has completed the last scheduled follow-up visit for the final patient enrolled in a Phase 2 trial of its TransVax(TM) cytomegalovirus (CMV) vaccine in hematopoietic stem cell transplant (HCT) recipients
SAN DIEGO, CA, USA | November 23, 2009 | Vical Incorporated (Nasdaq:VICL) announced today that the company has completed the last scheduled follow-up visit for the final patient enrolled in a Phase 2 trial of its TransVax(TM) cytomegalovirus (CMV) vaccine in hematopoietic stem cell transplant (HCT) recipients. The company expects to have data available in the first half of 2010.
"We reported promising results in July for TransVax(TM) for clinical efficacy and immunogenicity endpoints at the four-month interim analysis point," said Vijay B. Samant, Vical's President and Chief Executive Officer, "and in October we reported that the immune responses were sustained through the seven-month data point. We have now completed the patient treatment and follow-up on schedule and have begun collecting data from our clinical sites. We are hopeful that the final data will continue the favorable trends we have seen so far."
TransVax(TM) is a bivalent DNA vaccine containing plasmids (closed loops of DNA) encoding CMV phosphoprotein 65 (pp65) and glycoprotein B (gB) for induction of cellular and humoral immune responses. TransVax(TM) is formulated with a proprietary poloxamer-based delivery system. The Phase 2 trial is evaluating the potential for TransVax(TM) to prevent CMV reactivation in CMV-seropositive HCT recipients, which could reduce antiviral usage and CMV-associated disease.
In July, the company reported results from a four-month interim analysis in the Phase 2 trial favoring the TransVax(TM) vaccine over placebo across a broad range of clinical efficacy endpoints. In October, the company reported that T-cell responses to both CMV antigens encoded by the vaccine were sustained through a seven-month data point, after the last of four scheduled injections, and noted a promising trend in the antibody response against CMV. TransVax(TM) has orphan drug designation for HCT and solid organ transplant patients.
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 for 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 www.vical.com.
SOURCE: Vical Incorporated