Nobilon Advances First Vaccine Into Human Trials - Intranasal Influenza Vaccine Begins Phase I Clinical D... ( BOXMEER Netherlands March 13 /- Nob...)

Nobilon Advances First Vaccine Into Human Trials - Intranasal Influenza Vaccine Begins Phase I Clinical Development

Date:3/13/2009

BOXMEER, Netherlands, March 13 /PRNewswire-FirstCall/ -- Nobilon, the human vaccine business unit of Schering-Plough Corporation (NYSE: SGP), today announced that it has reached an important milestone with the initiation of its first-in-human clinical development program 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 (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 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 program of SCH 900795 represents Nobilon's commitment to bringing innovative vaccines for human health to the market using state
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