BOXMEER,
The candidate vaccine is composed of the three attenuated Influenza viruses recommended by the World Health Organization (WHO) for seasonal vaccine, in an intranasal device. The LAIV differs from most existing influenza vaccines, because it has been designed to offer (1) single-dose intranasal delivery, (2) advanced cell culture manufacturing technology and (3) potential earlier and broader protection against infection by influenza viruses.
The Phase I study consists of a randomized, double-blind, placebo-controlled, rising single-dose design and will include a total of 120 healthy volunteers. The primary objective of the Phase I program is to investigate the safety, tolerability and immunogenicity of escalating doses of SCH 900795 in adult men and women.
"I am pleased to announce the start of the first clinical development program of Nobilon," said
The initiation of the clinical development program of SCH 900795 represents Nobilon's commitment to bringing innovative vaccines for human health to the market using state-of-the-art technologies.
About Influenza
Influenza (flu) is a contagious disease caused by the influenza virus. Influenza is a significant cause of morbidity and mortality and seasonal epidemics are responsible for approximately 40,000 deaths and over 100,000 hospitalizations annually in the US. Influenza infection in children causes a significant increase in both medically attended illness as well as hospitalizations. Mortality due to influenza generally affects aging adults. Inactivated, parenterally administered influenza vaccines have been available since the mid-1940s and effectively prevent influenza illness in healthy adults. Vaccination of elderly generally has a lower impact on prevalence, but is up to 80% effective in preventing death. Nevertheless, current inactivated influenza vaccines have limitations and are underutilized. Intramuscular vaccination with needles is an important barrier for the acceptance of annual influenza vaccination, which may be overcome by intranasal application. Moreover, Live Attenuated Influenza Vaccine (LAIV) is expected to be more effective in inducing local and cellular immunity and as such may be more efficacious in eliciting protection.
About SCH 900795
Nobilon acquired in 2004 the majority of rights to develop, commercialize and manufacture the LAIV technology from Australian company BioDiem, which had acquired these rights from the Institute of Experimental Medicine in
About Nobilon
Nobilon International BV, a part of Schering-Plough Corporation, was founded in 2003 and was acquired through the Organon BioSciences acquisition in 2007. It has production and R&D facilities in Boxmeer and Oss,
SOURCE Schering-Plough Corporation