"We are pleased by the Safety Monitoring Committee's recommendation and look forward to advancing this critical study of our hepatitis B candidate. Hepatitis B is the tenth leading cause of death worldwide and our commitment to the development of this therapeutic vaccine is squarely in line with our mission - to protect life," said Daniel Abdun-Nabi, president of Emergent BioSolutions Inc.
The SMC reviewed the safety data from the first group of patients that have completed day 70 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.
About The Hepatitis B Therapeutic Vaccine Candidate
Although current treatment options are safe and effective in the majority of patients, the majority of hepatitis B patients are unable to clear the viral infection resulting in the need for long-term therapy. The company's HBV immunotherapeutic is designed to direct the immune system against virus infected cells in the liver. Following oral administration, the hepatitis B core antigen protein is produced by the spi-VEC Salmonella vector, within gut macrophages. The macrophages "present" portions of the HBV core antigen to the immune system, inducing antigen specific T-cells responsible for cell-mediated immunity. Through the targeted immune response, the company's hepatitis B immunotherapy is anticipated to benefit patients by increasing the potential to clear the virus therefore minimizing the risk of liver damage and eliminating the need for long-term antiviral therapy.
About Hepatitis B
The World Health Organization (WHO) estimates that up to 2 billion people (one-third of the world's population) have been infected with HBV and that between 350 and 400 million people are chronically infected. Globally, chronic HBV is one of the leading causes of advanced liver cancer. During their lifetime, 10-40% of chronic HBV patients will develop serious sequelae, such as hepatocellular carcinoma, cirrhosis and decompensated liver disease. Hepatitis B virus affects all countries and geographic areas throughout the world.
The hepatitis B market size is estimated to be currently valued at $500 million and is expected to double to over $1 billion by 2010. The strong market growth is attributed to an increase in the awareness and diagnosis of hepatitis B, as well as the increasing use of drug combination therapy.
No comments:
Post a Comment