BioDiem makes progress on influenza vaccine trial

Australian pharmaceutical development company BioDiem announced that the recruitment stage of the Phase I clinical trial of SCH 900795, an intranasal Live Attenuated Influenza Vaccine (LAIV) in development for annual seasonal use, has been completed.

The Phase I study was a randomised, double-blind, placebo-controlled, single rising dose design and included a total of 120 healthy volunteers. The primary objective of this first-in-human trial was to investigate safety, tolerability and immunogenicity of escalating doses of this vaccine in adult men and women. SCH 900975 is being developed by Nobilon, the human vaccine business unit of Schering-Plough.

BioDiem has licensed the majority of the LAIV rights to Nobilon Results from the Phase I study are not yet available, as data are still being analysed. However, a Phase II trial is planned for 2009/2010 to coincide with the next northern hemisphere influenza season. More details will be provided when the trial commences.

The candidate vaccine, SCH 900795, is composed of three attenuated (weakened) influenza viruses chosen according to the recommendations of the World Health Organization for seasonal vaccine, in an intranasal device. The LAIV offers several improvements over many existing influenza vaccines, such as a single-dose intranasal spray delivery, which is more convenient for people being vaccinated, an advanced cell culture manufacturing, rendering vaccine production independent of chicken eggs and the potential of earlier and broader protection against infection by influenza viruses.

Chief Executive Officer of BioDiem, Julie Phillips, said: “We are delighted with the progress made to date with this product and the promising information we have received so far. We look forward to receiving further information on this trial and the next steps when the analyses of the results are completed.”