Nobilon initiates Phase I influenza vaccine trial

Nobilon, the human vaccine business unit of Schering-Plough, has initiated its first-in-human clinical development program for SCH 900795, a new intranasal live attenuated influenza vaccine for annual seasonal use.

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.

The candidate vaccine is composed of the three attenuated influenza viruses recommended by the World Health Organization for seasonal vaccine, in an intranasal device.

Gelmer Leibbrandt, general manager of Nobilon, said: I am pleased to announce the start of the first clinical development program of Nobilon. This is an important milestone in the young history of our company. We are encouraged by the positive results obtained in the preclinical 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.

Nobilon, a subsidiary of Schering-Plough Corporation has production and R&D facilities in Boxmeer and Oss, the Netherlands. The biotechnology company is dedicated to developing, producing and marketing human vaccines.