Vical’s TransVax CMV Vaccine Shows Positive Result In Ongoing Phase 2 Trial

Vical Incorporated’s TransVax cytomegalovirus (CMV) vaccine continued to demonstrate an overall increase in cellular immune responses compared with placebo, at the seven-month immunogenicity data point in an ongoing phase 2 trial.

TransVax 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.

Reportedly, TransVax is formulated with a proprietary poloxamer-based delivery system. The phase 2 trial is evaluating the potential for TransVax to prevent CMV reactivation in immunosuppressed CMV-seropositive hematopoietic stem cell transplant (HCT) recipients, which could reduce antiviral usage and CMV-associated disease.

The company said that at the seven-month immunogenicity analysis, TransVax continued to provide increased cellular immunological responses to both encoded CMV antigens compared with placebo. TransVax has received orphan drug designation for HCT and solid organ transplant patients.

Rolland, senior vice president of product development at Vical, said: “T-cell responses are very important in protecting recovering transplant recipients against CMV disease and we were pleased to see that the T-cell responses to both CMV antigens encoded by our vaccine, noted in our four-month interim analysis, were sustained through the seven-month data point. In addition, we saw a emerging trend in the antibody response against CMV after the last of four scheduled injections. We look forward to reviewing the final trial data in the first half of 2010.”