Nobilon, the human vaccine business unit of Schering-Plough Corporation, has reached an important milestone with the initiation of its first-in-human clinical development programme for SCH 900795, a new intranasal Live Attenuated Influenza Vaccine (LAIV) for annual seasonal use.
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 single-dose intranasal delivery, advanced cell culture manufacturing technology and 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 programme 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 programme of Nobilon," said Gelmer Leibbrandt, general manager of Nobilon. "This is an important milestone in the young history of our company." Han van den Bosch, director R&D, stated, "We are encouraged by the positive results obtained in the pre-clinical development of our candidate vaccine so far and we believe that this vaccine has the potential to become an important tool in the prevention against seasonal Influenza illness."
The initiation of the clinical development programme of SCH 900795 represents Nobilon's commitment to bringing innovative vaccines for human health to the market using state-of-the-art technologies.
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.
Nobilon International BV, a part of Schering-Plough Corporation, was founded in 2003 and was acquired through the Organon BioSciences acquisition in 2007.