The Safety Monitoring Committee (SMC) reviewed the safety data from the first group of patients that have completed 70 days in the study. On the basis of the available data, the SMC recommended that the company continue to progress the study into the two remaining groups. The company anticipates preliminary top line safety and efficacy data from this study will be available at the end of 2008 and complete study results will be available in the first half of 2009.
In this study, a total of 45 patients with chronic hepatitis B virus (HBV) infection are being randomized within three separate groups to receive immunotherapy or placebo. The immunotherapy utilizes the company’s proprietary spi-VEC delivery system to deliver the hepatitis B core antigen, in order to induce an immune response to the hepatitis B virus.
Daniel Abdun-Nabi, president of Emergent BioSolutions, said: “We are pleased by the Safety Monitoring Committee’s recommendation and look forward to advancing this critical study of our hepatitis B candidate.”