BOXMEER, Netherlands, Oct. 13 /PRNewswire-FirstCall/ -- Nobilon, the human vaccine business unit of Schering-Plough Corporation (NYSE: SGP), today announced that it has initiated a clinical Proof of Concept trial with SCH 900795, a new intranasal Live Attenuated Influenza Vaccine (LAIV) for annual seasonal use.
"We are encouraged by the continuation of the clinical development program of SCH 900795 after interim results of Nobilon's first ever Phase I study had demonstrated that the primary study end point was met," said Han van den Bosch, director R&D at Nobilon. "We remain on track to continue the development program of our LAIV for annual seasonal influenza vaccination. In the new study, we will investigate safety, tolerability and immunogenicity of SCH 900795 in 140 healthy adults of 50 years and older. We are pleased that the first subject in this double-blind, randomized, placebo-controlled study has been successfully dosed."
The earlier Phase I study had a randomized, double-blind, placebo-controlled, rising single-dose design and included a total of 117 healthy volunteers between the ages of 19 and 50 years. The objectives of this study were to investigate the safety, tolerability and immunogenicity of escalating doses of SCH 900795.
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.
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 St. Petersburg, Russian Federation. SCH 900795 could offer several improvements over most current vaccines such as single-dose intranasal spray delivery, improved convenience and earlier and broader protection. SCH 900795 is manufactured using state-of-the-art cell culture technology, offering important advantages over egg-based production such as consistency and flexibility in production, reduced risk of microbial contamination, a more homogenous viral yield, and usability for subjects with egg allergies.
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, the Netherlands. The biotechnology company is dedicated to develop, produce and market human vaccines, building on existing expertise within Schering-Plough. One of its core expertises is large-scale cell culture production of viruses, including influenza. For more information, go to the website www.nobilon.com.
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription, animal health and consumer health care products. Schering-Plough's vision is to Earn Trust, Every Day with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its website is www.schering-plough.com.