Dynavax initiates Ph I trial of HBV vaccine

Dynavax Technologies Corp has initiated a Phase I trial of its novel therapy for chronic hepatitis B virus infection. The study is being conducted in Hamburg, Germany, and will enroll 20 healthy subjects to evaluate the safety of the therapy at two dosing schedules with results expected in the second half of the year.

According to the firm, the novel HBV therapy combines, for the first time, the surface and core antigen of HBV, manufactured at Dynavax Europe. Commenting on the study, Eduardo Martins, vice president, clinical development, said: "the trial represents the first evaluation of this therapeutic approach in humans. In addition to verifying safety, we will measure subjects' T cell responses to evaluate whether the vaccine demonstrates the same pharmacologic effects as those seen in animal models, namely the induction of virus-specific cellular immune responses."

Dynavax indicated that the hepatitis B trial is the second of several studies slated to enter the clinic with funding from Symphony Dynamo. In April, 2006, SD committed $50.0 million to Dynavax to advance its cancer program and both its therapies for chronic hepatitis B and chronic hepatitis C into human clinical trials. Dynavax announced the initiation of its SDI-funded Phase I cancer program in metastatic colorectal cancer in late 2006.